Hypericum perforatum

Our raw Hypericum perforatum is grown on a herb farm in Bulgaria (Bulgaria is a leading producer of medicinal herbs with over 750 different plant species grown in the country’s varied climate zones).

Hypericin levels in St John’s Wort show a wide seasonal variation, rising rapidly in spring when the flower shoots reach a height of between 5 and 10 centimetres and continuing to rise until the plant is in full flower, when the hypericin levels tend to fall back.

There are over 450 species of Hypericum perforatum, but few of these are known to contain hypericin so herb identification is essential.  Of the two main strains grown for hypericin the broad-leafed strain is indigenous to northern Europe and the narrow-leafed strain is indigenous to southern Europe (although of course commercial production of either strain can take place anywhere).  The narrow-leaf strain has been found to contain approximately twice the concentration of hypericin as the broad-leaf strain.

There are strong indications that hypericin production is roughly 20% higher in years which experience above-average rainfall.

Seedlings of St. John's Wort are slow growing and compete poorly with other plants.  The seeds need light for germination and should be sown shallow depths (not more than two millimetres). Deep planting results in weak young seedlings.

St. John's Wort produces a deep root system. Generally the best harvest time is when the crop is half in bud and half in open flower. Timing is important in order to capture the hypericin levels at their peak.

Later harvests may yield very low hypericin levels.  Harvesting is normally not done until the second year, as there is usually limited flowering in the year of planting. The crop is usually dried under cover, to help retain the colour and preserve quality.

Herbs In A Bottle supplies Hypericum perforatum as a Tincture (in litre and half-litres), a Fluid Extract (in litre and half-litres), a Fixed Oil (in litre and half-litres), Cut herb (500g) and Powder (500g).

NIMH Conference 2014

Herbs in a Bottle is pleased to Sponsor the 150th Conference of the National Institute of Medical Herbalists which is to be held in Nottingham this year.

Herbs in a Bottle is a Total Conference sponsor joining other sponsors within the four-day event.

David Carter, Managing Director of Herbs in a Bottle, said:

“When I learned that 2014 was to be NIMH’s 150th anniversary conference I knew it was an event I wanted to support.  I have personally attended the past two NIMH conferences and have been impressed with the dedication and enthusiasm of the medical herbalist profession and the importance of this sector to the health and well-being of the British population.  2014 promises to be a great conference for us with many of our customers attending, including overseas customers who have told us they will be there. 

“As well as being a Total Conference sponsor we will have a stand at the event and our staff will be meeting existing customers, attracting potential customers and showcasing Herbs in a Bottle to new NIMH members. It is my personal ambition to meet as many herbalists as possible and during the time I am at the conference I will be available to any NIMH member who wishes to talk to me. 

“It is not just at NIMH conference we seek to support herbalist practitioners.  As our customers they are the focus of our activity and over the years many have become friends and partners in our herbal medicine production.  It is only by listening to what herbalists want and continually investing in new facilities, processes and production that we have grown to be a stable and forward-looking manufacturer of herbal medicines.

“By sponsoring the 2014 NIMH Conference we are showing our commitment to the future.  We see Herbs in a Bottle as a major herbal medicine manufacturer long into the future – perhaps even the next hundred and fifty years!  NIMH is a great institution, and Herbs in a Bottle is also in a different way a great institution.  Together we can be a cornerstone of herbal medicine in the United Kingdom and beyond.”

David Carter

Cancer Research Race For Life

Above:  Sue and Lucy (standing second and third from left), Jos (standing sixth from left) and Kay (kneeling, in white).

Four Herbs In A Bottle staff took part in the Cancer Research Race For Life held in the grounds of historic Burghley House on 1st June.

Race for Life is a series of 5k or 10k women-only fundraising events, which raise money for research to help find a cure for all 200 types of cancer.

Curcuma longa or Turmeric Root

  

Today we are making tincture of Curcuma longa or Turmeric Root, also fluid extract, cut and powder versions.

• We obtain our raw Curcuma longa or Turmeric Root rhizomes from India which is the world's largest producer of the crop.
• Curcuma longa or Turmeric Root requires a hot, tropical climate to grow, and does well in a light soil - healthy plants grow a metre high.
• Curcuma longa or Turmeric Root is brownish-yellow colour and when cut has a orange interior (becoming bright yellow when dried and powdered).
• Farming techniques and local climate can influence curcumin content of Curcuma longa - it can vary from 2% to 8% (testing the crop is vital).

Are you going to the URHP Conference this year?

Annual Conference & AGM

Friday 20th, Saturday 21st and Sunday 22nd June 2014

WITH GUEST SPEAKERS - LESLEY AND MICHAEL TIERRA

Purley Chase Centre, Purley Chase Lane, Mancetter, Atherstone, Warwickshire CV9 2RQ

Tel: 01827 712370 www.purleychasecentre.org.uk

It is with great pleasure to announce that our guest speakers, for most of this year’s AGM and conference weekend, are Lesley and Michael Tierra. They are the world’s leading herbalists and renowned for their pioneering works in Chinese and many other fields of herbal medicine. They are bringing with them some exciting talks and healing demonstrations. If you know anything about Michael and Lesley Tierra, you will know that attending their specialist workshops is an opportunity not to be missed especially as
they are not often in the UK.
 
The cost of the full event is £75.00 for URHP members and £85.00 for non-members. A deposit of £20.00 can be placed with initial early booking. The cost for a part session is £30.00 with a £10.00 deposit on early booking. The outstanding costs must then be paid by 18th May. A part session is for any one day attendance. The AGM meeting is free.

Purley Chase has 60 beds available in single and shared rooms. If you would like to stay there overnight and include meals, please book the accommodation as soon as possible directly with them. The booking form can be found on their website. A £30.00 deposit is required with the outstanding balance to be paid by 12th June 2014. Please state you dietary requirements and those attending part sessions please book meals or snacks as needed.

The nearest for other accommodation is Bed and Breakfast on the A5 at Dordon called the Chestnuts or at Mancetter on the A5, or The Bull (3 miles away). There are many others to be found around Atherstone. The nearest main line railway station is at Nuneaton, about 10 kilometres away. Nuneaton is on the main line between London and Lancashire, and trains also serve Atherstone about 2 miles away.

For more information, please contact Jane Woolley Tel: 0151 336 2693
Email: janewoolley1@aol.com

Conference Programme

Friday

4:30 pm – 5:30 pm Registration

5:30 – 6:30 pm Dinner

7:00 – 9:00pm Michael Tierra:
practical pulse diagnosis related to herbal practice and herbal approaches to the treatment of acute bacterial and viral diseases

Saturday

10:00 am – 1:00 pm Lesley Tierra:
Tongue diagnosis and herbs

11:45 am – 12:00 pm tea break

1:00 pm – 2:00 pm lunch

2:00 pm – 5:00 pm Michael Tierra:
Practical pulse diagnosis continued and the treatment of shen (Mind-Spirit) disorders

3:45 pm – 4:00 pm tea break

5:30 - 6:30 pm dinner

7:00 social drinks at the bar

Sunday

10:00 am – 11:45 am Lesley Tierra:
Herbal treatments for menopause and depression.

11:45 am – 12:00 pm tea break

12.00 pm – 1:00 pm
Tribute to Teresa Barlow

1:00 – 2:00 pm lunch

2:00 pm AGM meeting

NB All handouts will be sent nearer the time. Also, we will be asking for volunteers for the healing demonstrations at the time of the event.
Note Herbs in a Bottle is not involved in the organisation of this Conference and no responsibility can be accepted by HIAB for any aspect of the Conference.  All communication must be with the Conference organisers as detailed. 

Next year's Scutellaria lateriflora (Skullcap) crop

Above you can see next year's Scutellaria lateriflora (Skullcap) crop being planted on a specialist herb farm in an organic valley in north-west America.

Herbs in a Bottle have already contracted to buy this crop, assuming it meets the pre-set quality criteria.  Over the coming weeks and months we will be receiving regular updates on how the crop is progressing.  It is genuinely exciting for us to see the tiny shoots grow to maturity, nurtured with care and love (love is not an exaggeration - the herb farm is staffed by herbal enthusiasts!).

We are very careful on how we choose the farmers and growers who supply our herbs.  We ask many searching questions on the history and ownership of the company, and look for partners who match our high ethical standards.  We also rate suppliers on the current licences they hold, and monitor renewal dates of those licences.

The management structure of a company is also of interest.  We look for people who are motivated as well as just technically competent.  Above all we value an interest in herbs (an enthusiasm for herbs is very hard to fake). 

Quality systems also receive scrutiny.  We look for documented control procedures and accountability (ideally we want named individuals who will take responsibility for each stage of the growing, harvesting and forwarding process).  Complete traceability of every batch is essential. 

Obtaining raw herbs is more than just a matter of legislative compliance, codes of practice, and growing guidelines (vitally important though these elements are).  We are interested in how raw herbs are stored prior to shipment and who has access to them (and what clothing they wear and whether they have been trained in hygiene procedures).  We even ask about the drains and where they flow to.

Employee training is another area we ask about.  We ask questions about induction of new staff and whether any casual or agency staff are ever employed.  As well as training and re-training, we also ask whether training records are audited (and who by).

Medical screening of staff is additional area of interest for us, and we will want to know what medical facilities the supplier will have, and what the reporting procedures are for staff who become ill.

This might all sound very single-minded and procedural, but as well as the details we are also interested in the wider picture.  The quality of the air, the purity of the water, the health of the soil - all contribute to the value of the herbs.  That is why we look for farmers and growers of integrity, living in harmony with nature.

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Solidago virgaurea or European Goldenrod herb

Today we are making tincture, fluid extract, powder and cut herb versions of Solidago virgaurea or European Goldenrod herb.

Solidago virgaurea is a native European species and can be found throughout the continent.

All parts of the plant are used except the root.

We obtain our supplies of raw Solidago virgaurea from Poland where it is regarded as a valuable medicinal plant and has been the subject of a number of academic studies.

In Poland Solidago virgaurea is gathered from a variety of wild sites - mainly lowlands, low mountains, dry meadows and forest glades.  Solidago virgaurea abundance in the wild is evaluated according to the Braun-Blanquet scale - if it is not abundant it must not be gathered.  Wild harvesting of herbs can result in variation in the content of biologically-active compounds, therefore sampling is prudent.

Harvesting sites are traditional.  Three harvests are carried out - May/June, July and September.  Variations have been recorded in the compound content of the herb according to when it is harvested, and also the conditions under which it has been grown.

Studies indicate content of polyphenolic acids greatest in the first and last harvests.

Solidago virgaurea seems to prefer partially shaded sites - it does well in a light indicator of 3.0 to 4.0.  The highest content of flavonoids has been obtained from plants grown in this light range.  Significant differences in flavonoid content have been recorded in Solidago virgaurea according to raw material origin within Poland.

Studies indicate that the highest content of flavonoids in Solidago virgaurea is found during the vegetative stage (before flowering).

However studies are at an early stage. 

Irrespective of where and when grown Chromatographic analysis (HPLC) of all samples of Solidago virguarea show the three flavonoids rutin, astragalin and hyperodside plus the two polyphenolic acids rosmarinic and chlorogenic. 

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Shards of glass, splinters of glass, crushed glass – all have frightful consequences

Out of all the dangerous substances that can contaminate herbal medicines, glass must rank as among the most alarming. 

Shards of glass, splinters of glass, crushed glass – all have frightful consequences if they are ingested or accidentally rubbed on the skin.

“This is just common sense” you might say.  No-one in their right mind would allow glass anywhere near herbal medicine production.  Even to suggest the idea of glass contamination is unnecessary fear-mongering.

Until you stop to calculate all the possible ways in which glass might be brought onto a production site and, despite all normal standards of care and attention, find its way into finished goods.

That is why at Herbs in a Bottle we give glass special attention with glass awareness training, glass control processes, and glass safety systems – all defined in our operating procedures and audited as part of our GMP licence.

We start with limiting the amount of glass that is allowed into Essendine and strictly controlling the conditions under which it is allowed into production areas.  For instance, staff are advised not to bring glass onto site.  Use of glass for drinking purposes is confined to the canteen and offices. 
Herbs in a Bottle tinctures and fluid extracts are not produced in glass bottles.

Customers can, for large orders, request production into glass bottles under very strict control conditions.  Smaller sizes of essential oils are stocked in glass bottles.  We also offer glass bottles as part of our packaging portfolio.

Glass packaging (which only comes from approved suppliers) is carefully inspected when it is delivered.  The checks have to be documented.  If there is any evidence, however slight, that the glass has been broken the delivery is turned away. 

Within our warehousing are designated areas where glass must be stored and monitored.  Outer containers of glass bottles must be resealed after opening.  The stock is regularly inspected.

Laboratory glass (instruments of various kinds) must not leave the laboratory suite.  No laboratory glass must leave the QC rooms.  Plastic measuring cylinders and jugs are provided for use outside the laboratory.

Inevitably where glass is allowed there will from time to time be breakages.  It is important therefore that everyone is trained to know what to do when breakages occur.  It is not enough to just sweep it up and hope for the best. 

All glass breakages must be reported and the risk of contamination assessed.  All activity within the area of the breakage must stop and the area is isolated until the breakage is dealt with.  It is important to realise that spread of glass shards from a breakage may be over a significant area, and therefore all the equipment and floor must be cleaned, washed, swept and vacuumed. 

For all breakages a Glass Incident Form must be completed describing the incident, and the action taken in response.  Radius ratios are taken into account when deciding how far the cleaning should extend.  Designated cleaning materials (coloured red) must be used in glass incidents, and soles of shoes inspected and cleaned.

After clean-up has been completed our Quality Supervisors then carry out minute inspections of the area using a sticky tape medium to look for any evidence of glass shards.  If any are found the decontamination process must be repeated.  Only when the QC inspection is positive can the area be released and the clearance signed-off.

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Juniperus communis or Juniper Berry

Today we are making Tincture, Fluid Extract, Cut and Powdered versions of the herb Juniperus communis or Juniper Berry.

We also offer the herb as an Essential Oil in 10ml bottles.

We obtain our raw Juniper berries from Albania where they are collected from wild - the berries must be dark blue in colour when they are picked.

The tincture has an aromatic odour and a bitter resinous taste.

www.herbsinabottle.com or see a pdf version of our catalogue

Labelling

You might think that labelling was a relatively minor part of herbal medicine production. 

You could not be more wrong!

Effective labelling is of fundamental importance to everything we do.

Careful control of identity labels is VITAL.  Think of the awful consequences of giving a patient the wrong product or the wrong strength because an erroneous label was used.  That is why we have strict regulations for labelling from arrival of raw herbs to despatch of finished medicines.

Examples of labels include sample labels, raw material labels, percolator bucket labels, product labels and many other variations.

Controlling all these labels in a fast-moving production environment requires conscientious staff following regulations and paying great care to details. 

All labels are controlled.  There are never occasions when labels are lying around loose.  If there are surplus labels at the end of a particular operation they must be destroyed.

Staff must report labels that are "stray" or otherwise defective.  Labels adrift, labels falling off, labels that appear to be in the wrong place or on the wrong item - all these must be reported.  Also any labels that are damaged, dirty or faded.

Labels must never be put on lids (in case lids are switched for any reason).

Supervisors who are authorised to control labels are carefully identified in our staff structure and trained.  Once labels are issued they are checked according to a set procedure - particularly the form of the medicine (whether tincture, fluid extract etc); whether the Latin binominal name matches the common name and whether the spelling is correct; whether the plant part (root, leaf, bark etc) is correct; codes receive special attention and checking as do batch numbers; country of origin must be correctly identified - and many other items of information that goes onto our labels.

Bulk labels are stored in locked cupboards and only designated staff are allowed access.  Labels are controlled items in our stock inventory and when issued have to be reconciled.  The quantity printed, used and disposed of has to balance.

At the risk of sounding obsessive, it is no exaggeration to say that labels are an all-consuming all-important fact of life at Herbs in a Bottle!

Purchasing raw herbs

The way we purchase raw herbs is of crucial importance to achieving consistency of finished products.  As everyone knows, it is not possible to make a silk purse out of a sow's ear.  High quality herbal medicines can only be made from high quality raw materials.

The Herbs in Bottle purchasing procedure has been built up from many years' experience buying raw herbs worldwide - and this experience has now been defined, codified and audited as part of GMP.

The emphasis is upon safeguarding the materials that are supplied to production, so that we (and you) can be sure that they come from reliable known sources.

We do not grow any of our own herbs.  We have taken that decision to ensure that our production process can be independent of any commercial pressures to process what is grown, even when harvests are deficient in quality.  We would prefer to go out of stock for a while rather than put through raw materials that are inconsistent in quality.

All growers and wholesalers on our approved suppliers list are assessed prior to first purchase, and then assessed at defined intervals thereafter.  The suppliers are required to quality assess all deliveries according to criteria we supply them.  This includes provision of relevant certificates of analysis and test results that comply with agreed specifications.

All suppliers must maintain and provide on request records that include full batch traceability. 

Our Quality department monitors whole of the purchasing process.  This includes maintaining the approved supplier list; obtaining correct information; supervising packaging specifications; controlling codes for raw materials and packaging; investigating complaints.

Herbs in a Bottle will monitor all supplies of raw materials, testing every batch supplied and auditing (and re-auditing) the supplier's at their site. 

It goes without saying that we will refuse suppliers that show any evidence of non-compliance (lazy performance, sloppy standards, inadequate or misleading paperwork etc).

It gives you peace of mind that when you purchase from Herbs in a Bottle you are getting high-quality medicines that are fit for purpose.

Rosmarinus officinalis or Rosemary Leaf

Today we have manufactured Rosmarinus officinalis or Rosemary Leaf Tincture, Fluid Extract, cut and powdered herb.

Constituents of Rosmarinus officinalis include antioxidants, carnosic acid, rosmarinic acid, betulinic acid, rosmaridiphenol and rosmanol.

We also offer Rosemary as an essential oil - 10ml, 20ml, 50ml, 100ml, 500ml.

According to a Defra (Department of Farming and Rural Affairs) report Rosmarinus officinalis antioxidants levels are closely related to soil moisture content.

The World Health Organisation (WHO) report on increasing resistance to antibiotics

There have been extensive reports in the media about the World Health Organisation (WHO) report on increasing resistance to antibiotics (see for instance http://www.bbc.co.uk/news/health-27204988 ).

The WHO report envisages "post-antibiotic era, where people die from simple infections that have been treatable for decades" (Pippa Stephens Health reporter, BBC News).

Herbs in a Bottle urges everyone interested in this issue to read the evidence submitted to the House of Commons Science Committee by eminent medical herbalist Michael McIntyre (Chair of the
 European
 Herbal
and 
Traditional
 Medicine 
Practitioners
Association
).

Entitled Herbs to combat the threat of microbial resistance to antibiotics the submission can be read on the website of the National Institute of Medical Herbalists:  http://www.nimh.org.uk/wp-content/titkosuploads/2010/10/Presentation-on-anti-microbial-resistance-to-the-House-of-Commons-Science-Committee.pdf

Herbs listed in the report are:

Thymus vulgaris
Sophora alopecuroides
Rosmarinus officinalis
Coptis chinensis
and
Phellodendron amurens
Scutellaria baicalensis
Wrightia inctoria
Dendrobenthamia capitata
Elsholtzia rugulosa
Elsholtzia blanda
Geranium strictipes
Polygonum multiflorum
Salvia
officinalis
Isatis
tinctoria
Echinacea
purpurea or angustifolia

Arctium lappa
Arctostaphylos uva ursi
Zea mays

It is vital that the medical establishment takes seriously this evidence.

Fluid Extracts

Manufacture of fluid extracts from raw medicinal herbs is a satisfying and rewarding process, with the aim of producing a high quality product that meets set specifications.

At Herbs in a Bottle we use two pharmacopoeia techniques to create fluid extracts - maceration and percolation.  

Maceration is the pre-soaking of the raw herb in a prescribed strength and quantity of menstrum for a minimum period of twelve hours.  This allows complete penetration of solvent through the cell walls of the plant materials and diffusion of cell contents into the menstrum.

Percolation is a process undertaken in stainless steel conical percolators which facilitates extraction by the processes of diffusion and washout - the continuous movement of menstruum against plant cell walls maintaining high concentration gradient and an efficient extraction.

The manufacturing process is scheduled by Production Managers who check the availability of raw materials, determine the required production volume and issue Works Orders with a product batch number.

Labels are issued for percolators and buckets to ensure every stage is carefully recorded (and the records will be reconciled and checked by the appropriate superviser).

Raw materials are requested by means of the Works Order.  The stock is picked by batch number.  Careful weighing takes place and the raw herbs are delivered to the production area.

The required solvent for that particular herb will be requested (for instance, a 1:1 45% of Valeriana officinalis rad requires one part macerate to one part menstruum, solvent system 45% Ethanol v/v in water).

Equipment used includes macerating bins (which are white buckets fitted with white lids that provide an air tight seal); conical 50 litre stainless steel percolators; filter discs; funnels and collecting bins.  All equipment must be thorough cleaned before and after use, and inspected as clean by our QC department.

The raw materials are then weighed directly into the clean labelled macerating bins (cleaned and sanitised).  Hygiene checks are carried out by a supervisor.  The required amount of solvent is measured out in a graduated stainless steel bucket.  Each bin is filled with the required amount of liquid and then sealed and transferred to the maceration area where it is left for a minimum soak time of twelve hours.

The percolators are prepared, and the filter discs covered with muslin dampened in pure water.  The lid, funnel and stopper are assembled.  The pre-soaked material is divided and carefully loaded into the percolators and tamped.  The required amount of solvent is measured and poured into the percolator.  The vessel is closed and transferred to the extraction area.  

Percolator taps are opened after a short standing time and the date and start time recorded.  Flow rate is a fast drip of ten drops per second.  The rate of percolation is carefully monitored and is influenced by gravity and osmosis.  

Intermediate QC tests are carried out during percolation, observing strict hygiene procedures (the QC supervisor wears gloves, jugs and ladles are sanitised, nothing must be put on the floor etc).  

At completion further QC tests take place to ensure the liquid meets the specification.

Following completion a thorough equipment clean takes place (using a specified detergent then soaking, scrubbing, sanitising, and comprehensive rinsing).

Following the equipment clean down a thorough area clean takes place.

Of course, this is just a brief precis of the production procedure - you are very welcome to visit our Essendine facility to see the full process in operation.

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Scutellaria lateriflora

Our supply of Scutellaria lateriflora or Skullcap Herb growing on a specialist Organic herb farm in North America.  The soil you can see is volcanic ash.  All the water used for irrigation on the farm is melted glacier water - exceptionally pure.

Scutellaria lateriflora is sensitive to the climate and sometimes the crop can fail.

Shortages of Scutellaria lateriflora can lead to price rises as buyers try to outbid each other.

This creates a time of risk for medical herbalists as manufacturers may be tempted to purchase supplies of the raw herb from dubious sources.

Always buy from a GMP licensed company - or insist on a bona fide Certificate of Analysis.

Good Manufacturing Practice

Herbs in a Bottle is a Good Manufacturing Practice (GMP) company.  Our GMP licence is MIA 37212.  You can check whether a company holds a GMP licence by looking at the MHRA Register here:  http://www.mhra.gov.uk/home/groups/is-lic/documents/publication/con2030303.pdf

Among herbal medicine manufacturers there are, unfortunately, many weasel words spoken about GMP.

You will often hear "We work to GMP standards" or "We are GMP equivalent" or "What does GMP mean anyway, at the end of the day it's just a paper chase!".

To help dispel some of the misinformation here are some key facts about GMP:

GMP is a quality assurance standard that ensures herbal medicines are consistently manufactured to a pre-determined level of quality.  This means that GMP has two aspects - manufacturing and quality control.  Once a GMP licence has been granted it is enforced through inspections (both scheduled and unannounced) by the Medicines and Healthcare products Regulatory Agency (MHRA).

To gain a GMP licence a company has to follow the Rules and Guidance for Pharmaceutical Manufacturers and Distributors commonly known as the Orange Guide.  By buying from a GMP licensed company medical herbalists are able to state that they are prescribing medicines manufactured to pharmaceutical standards.  We are happy for our customers to state on their websites that they buy their medicines from Herbs in a Bottle and quote our GMP licence number.

The GMP process is, for Herbs in a Bottle, an all-encompassing regime but it can be defined as ten basic rules.

1  All manufacturing procedures are defined in detail in a series of written instructions (SOPs), and training is given on those procedures.

2  The written SOPs must be followed EXACTLY - no cutting corners, no special exceptions.

3  The correct raw materials are defined and specified, and purchased to that specification - if on delivery to Essendine they fail our sampling and testing process they are rejected.

4  The correct equipment must be defined and specified, and training on correct use of equipment (including cleaning regimes) is mandatory.

5  Production staff are trained in all issues around contamination and its prevention.

6  Correct labelling is regarded as crucial to the manufacturing process.

7  Production staff are trained and monitored so that they work accurately and precisely.

8  Production staff are required to follow hygiene and good housekeeping procedures.

9  Above and beyond the formal SOPs all staff must be alert for possible sources of contamination and report anything that might be suspicious.

10  All production staff must keep accurate records of what they have done.

By purchasing your medicines from Herbs in a Bottle you can be sure that you are not prescribing to your patients any toxic or substandard products.  GMP is not a cheap standard to achieve, and means we have to employ more QA and supervisory staff than non-GMP companies, as well as maintaining a higher level of machinery and insisting on higher specifications of raw materials (rejecting substandard herbs can mean we go out of stock for particular items).  Yes, you can get cheaper medicines from other manufacturers - but if they are not GMP licensed the money you save could mean extra risk for your patients.

Our catalogue:  http://herbsinabottle.blogspot.co.uk/2014/04/our-catalogue-is-now-in-searchable-pdf.html

Our website:  www.herbsinabottle.com

Our catalogue is now in a searchable pdf format

The Herbs in a Bottle catalogue is available as a pdf:

Catalogue

It includes a search box, so just type in the name of the herb you are interested in and it will take you straight to the page.

If you want to order just send the product code and amount to sales@herbsinabottle.com and we will process the order and contact you to arrange payment.

Please note that we can only sell to qualified medical herbalists.

Herbs in a Bottle now member of ESSNA

Herbs in a Bottle is pleased to announce that the company has been accepted as a member of ESSNA, the European Specialist Sport Nutrition Alliance.

ESSNA is an association representing the interests of the sport nutrition sector across the European Union.

It was created in 2003 to campaign for appropriate European legislation on sports nutrition products. The association is a respected organisation, widely recognised by legislators and the mainstream media as the voice of the responsible specialist sports nutrition sector in Europe.

ESSNA cooperates actively with the European Institutions and Agencies, national governments, trade bodies, consumer organisations, leading scientists and the media to ensure the fulfilment of its missions.

As a member of ESSNA Herbs in a Bottle with be helping to work towards the following objectives:

• To ensure the development of an appropriate and balanced regulatory framework for sport nutrition products
• To keep abreast of on-going legislative developments to ensure compliance
• To promote reputable sport nutrition brands in the media
• To address the issue of non-compliant products tarnishing the reputation of the sector
• To promote initiatives and campaigns to inform consumers of the benefits of regular physical activity, healthier diets and responsible use of sport nutrition products
• To support continued independent scientific research into sport nutrition and into issues relating to quality and safety

More information:  http://www.essna.com/

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What does our Hygiene policy mean to you...

We take great care over hygiene at the Herbs in a Bottle Essendine site, and everyone who joins the company will go through our Hygiene Training and on-going inspections.

Clothing

Everyone who works in our production areas is required to wear designated overcoats (made of a durable material with no pockets and no button fastenings).  They must also wear hair nets so that hair and ears are completely covered at all times.  The net must be put on before the coat to avoid any hairs getting onto the coats.

Only work shoes can be used in production areas, and outdoor shoes must be left in the locker room.

No watches or jewellery are allowed (with the exception of plain gold wedding bands).  Wearing nail varnish, strong perfume or excessive make-up is not permitted.  Mobile 'phones and other personal electronic equipment cannot be taken into the production areas.

At the start of each shift all production personnel are inspected by their managers.

All staff are reminded that raw materials, intermediate or finished products must not come into contact with bare hands.

Food and Drink

Drinking water is provided at a specific point in the Despatch office.  Otherwise no food or drink is allowed in the production areas.  A staff canteen (outside the production areas) is provided where staff can take their breaks.

Smoking

Herbs in a Bottle Essendine is a no-smoking site.

Personal Hygiene

All production personnel are required to wash their arms and hands thoroughly before commencing work and regularly throughout the day as required (and always after toilet visits).  Washing arms and hands between product batches is mandatory.  Fingernails must be kept short and clean.

Exposed cuts and abrasions must be covered with blue detectable waterproof dressings.

Health declaration forms must be completed by all production staff returning to work after an absence (including holidays abroad), after sickness and after any unauthorised absence.

Stomach upsets developing on-shift must be reported immediately to a supervisor.  All personnel suffering from or coming onto contact with infections (eg typhoid, dysentery, staphylococcal infection) must immediately inform the management team, and where necessary health clearance from their doctor will be required before they can return to work.  No personal medications are allowed in the production areas.

Visitors

All visitors to the Essendine site are recorded and must complete a health questionnaire.  Visitors cannot enter production areas without authorisation, and must comply with the rules on wearing protective clothing including shoe coverings.  Hand wash rules also apply.

Miscellaneous requirements

There are many other hygiene procedures in force throughout Essendine, and these vary according to the equipment operated and the way the respective herbs are processed.  For instance, disposable aprons and gloves are worn for processing powders and dry herbs; special green coats must be worn in the mill room; spillages must never be returned to clean stock etc.

What does our Hygiene policy mean to you...

The high standards we insist upon through our Hygiene policy mean that our products are clean and uncontaminated.  We always keep in mind the fact that ultimately our medicines will be prescribed to people who are ill and often will have low immunity.  Cleanliness and hygiene is not just good business, it is a moral duty to those end users we seek to serve.

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Ensuring harmful foreign matter does not enter herbal medicine production

It goes without saying that herbal medicines should not contain poisonous, dangerous or otherwise harmful foreign matter or residue.

At Herbs in a Bottle we work hard to ensure the raw herbs we use are entirely free from contamination by moulds, insects, and other animal contamination including animal excreta.  The first check we do is visual, looking for abnormal odours, discolouration, slime or signs of deterioration.  Soil, sand, stones and dust are also looked for.

During storage we take special care to avoid formation of moulds since they may produce aflatoxins.

As well as macroscopical examination (looking at the shape, size, colour, surface characteristics, texture, fracture and appearance) we also use microscopy (HPTLC) which provides most of the information we require on the identity, purity and often the quality of the raw herbs.

Additionally we will test for loss on drying (which determines water and volatile matter), and we will carry out ash tests (both total ash and acid-insoluble ash).

Tests are carried out to determine the volatile oils.

Tests are carried out to determine the swelling index (the volume in millilitres taken up by the swelling of one gram of herb under specified conditions).

We strongly encourage our customers to visit Essendine and see our sampling and testing regime - it will give you complete peace of mind that the medicines you are prescribing for your patients are safe and uncontaminated.

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The importance of sampling

The only way to ensure the purity and integrity of herbal medicine production is through eternal vigilance.  This must include a stringent and rigorous sampling regime.  Only through comprehensive sampling can control over quality be maintained.

When you purchase herbal medicines do not accept bland assurances that samples have been taken of the raw herbs.  A sample is only reliable if represents the whole batch.  Here is a brief overview of the Herbs in a Bottle sampling procedure:

All deliveries of raw herbs are sampled, with samples taken from the upper (not less than 10cm from the top), middle and lower parts of a container or package.  Samples of seeds are withdrawn with a grain probe.   In mass samples must be as uniform as possible.

The average sample is quartered - dividing it diagonally into four equal parts.  Two opposite parts are carefully mixed, and the process repeated until the required quantity is obtained for the testing to be carried out.  A portion of the final sample is retained to act as a reference.

Tests are carried out on the following:

• Organoleptic characteristics (colour, texture, odour)
• Presentation of material (raw, crushed, cut compressed)
• Presence of admixtures, foreign matter (sand, glass, particles, dirt), mould or signs of decay
• Presence of insects
• Presence of packaging material originating from poor or degraded containers

If the sample fails the tests the batch cannot be used in production.

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Allergen management and control

When you buy herbal medicines, do you know what your supplier's policies and procedures are towards towards allergens?  Do they even have policies and procedures?  Or are they just putting different raw materials through production and hoping for the best?

At Herbs in a Bottle we recognise the potential risk to human health from materials derived from sources classified as potentially allergenous.  Strict rules of cross-contamination control (based on HACCP) are in place.  As a GMP company we take very seriously the implementation and auditing of allergen management and control.

The following are considered potential allergens:

• Peanuts
• Nuts - including almonds, hazelnuts, walnuts, pecans, Brazil nuts, macadamia nuts, cashew nuts, pistachio nuts, Queensland nuts
• Eggs
• Milk
• Crustaceans
• Sesame seed
• Fish
• Soya
• Celery
• Mustard
• Sulphur dioxide and sulphites
• Lupin
• Molluscs
• Cereals containing gluten (wheat, rye, barley, oat, spelt, kamut)

All our suppliers are required to have nut and allergen control strategies in place and provide appropriate documentation providing traceability of raw material batches.

If allergens are allowed into Essendine they must go into designated storage locations for potential allergens and undergo risk assessment on the source and composition of the material.  The raw materials will be labelled with "Potential allergen" warnings and stored in sealed packaging.  The stocks are controlled in production and reconciled after production.

Great stress is placed on avoiding any cross-contamination.  Procedures include comprehensive staff training, documented cleaning procedures, application of validated cleaning methods and pharmaceutical-standard positive/negative air balance in the production rooms.  A designated supervisor will assess production rooms, equipment and personnel prior to and throughout manufacturing.

Rooms have prohibited entry status before and during manufacture and during the comprehensive end clean down.

After manufacture all containers are sealed, decontaminated on the exterior, and removed.

Our QC department routinely takes samples from the final cleaning rinse to ensure no possibility of cros-contamination - these samples undergo HPTLC analysis.

When you buy Herbs in a Bottle medicines you can be sure that your patients will not be adversely affected by cross contamination with allergens.

Inula helenium root

Today we are making products from raw Inula helenium root - cut herb, powder, fluid extract and tincture.

As with all raw herbs entering Essendine, the roots will go through many tests before they are released for production including formal identification; formal check on status (GMO herbs are not allowed onto our Essendine site, and all herbs must have documented proof that they are GMO free); microbiological analysis (including checks for TVC, enterobacteriacea, yeast & moulds, E-coli, Salmonella, Staphylococcus Aureus); checks for toxins (including lead, cadmium, mercury and arsenic); checks for pesticide residues, checks for aflotoxins etc

If for any reason the raw herb fails the tests it is rejected - there is no possibility it can be released for production, no matter how urgent the demand might be.

Calendula

Calendula is one of the most versatile plants in our Materia Medica and deserves special attention.

We obtain the finest Calendula flowers from each new crop and carefully check all aspects of quality, including a full pesticide residue analysis.

Our extracts are carefully percolated without the use of additional heat.

Tests

The arrival of new consignments of raw herbs at Herbs in a Bottle is a routine event, and yet every delivery is significant.

Although suppliers are selected with great care, it is impossible to take anything for granted.  On arrival the delivery receives a visual inspection to check the integrity of the external packaging, the consistency and identity of the raw herbs and excipients, and the quality and integrity of glass and plastic packaging in contact with the product.  Documents are completed and if the herbs are organic additional steps must be taken.

Sampling is a key stage of the booking-in process.  Chemistry and physical examination takes place at Essendine.  Micro testing takes place at an independent laboratory and checks include Yeast & Mould, Stepholococcus aureus, Enterobacteriacea, E. coli, Salmonella and Total Viable Count.

Until the test results are obtained the herbs are held in our Quarantine area and stay there until all quality control tests are completed and compliance with specifications has been confirmed.

A smooth flow of raw materials into our Essendine facility

The Herbs in a Bottle warehouse contains over three hundred and fifty herbs in their raw state, imported from all over the world.  Described by visitors as an Aladdin's cave of herbal treasures (some of them very rare and valuable) managing this cornucopia is a demanding challenge that requires a skilled team of warehouse professionals.  Their task is to ensure a smooth flow of raw materials into our Essendine facility.

Deliveries to the Essendine site are strictly managed so that we do not having arrivals appearing unexpectedly and unauthorised people wandering about the site.  We require suppliers to use approved hauliers and our staff will refuse to unload herbs from any vehicle that appears to have been contaminated by a previous load.  Any damaged packages are immediately rejected.

Complete traceability is an essential component of herbal medicine production, therefore all raw herbs arriving at Essendine must be accompanied by valid documents - haulier documents, supplier delivery notes, Certificates of Analysis.  Pallets must be clean and of sound structure so that the consignment of herbs can be securely stacked and strapped.

Any packaging (boxes, bags etc) containing the raw herbs must be of food grade standard and checked to comply with EU Directive 2004/14/EC (which covers migration of contaminants).  Poly-weave sacks have to be non-permeable, cardboard boxes must have poly-liners etc.  Hessian sacks are banned, and the only paper packaging allowed are sturdy multi-ply sacks with a maximum weight of 25kg.

Labelling is of crucial importance.  Mandatory requirements are supplier name and emergency contact details, product name, product identity code, batch number, date of processing, and weight in kg.  Organic herbs must have certification logo and certification number on the label.

Customers are encouraged to visit Essendine to see our warehousing procedures in action.

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Quality checking procedures in the packing room

During the visit by Lincoln College students the HAIB QA Supervisor Lynn Windsor explains the quality checking procedures in the packing room.

Visit by students from Lincoln College

Herbs in a Bottle welcomed students from Lincoln College earlier today who toured our Essendine facilities and attended a presentation on the production of herbal medicines.

Medical herbalist and NIMH member Katie Dobiesz led the tour, and said:  "The students were impressed by every stage of the production process and were surprised at the vast array of tinctures and fluid extracts that we produce".

Above:  The Quality Control lab was a particular interest, and here we see one of the students examining the HPTLC equipment.

Above:  Lab Technician Rosie about to demonstrate HPTLC process.

Above:  one of the students with the HPTLC identification of Scutellaria lateriflora.

Powdered herbs

Producing powdered herbs of the consistent quality required by medical herbalist practitioners involves four staff following a sixteen-stage procedure.

Planning is key, as well as careful pre-checking and recording of the raw herbs (already tested by our QC department). 

Throughout the production process hygiene checks are mandatory and the milling machine needs to be absolutely clean to prevent cross-contamination - this means cleaning the hopper, the sieve, the chute, and the extraction chamber, as well as ensuring the floor is perfectly clean and there is no powder on any surfaces.  Scoops and tools also need to be cleaned and in pristine condition.  Cleaning must be carried out by personnel specifically trained to understand the milling machine and how it works as well as understanding the implications of not cleaning properly.  At the end of the preparatory clean the room must be inspected and (if all complies) signed off.

The milling machine is a "disintegrator" consisting of a feed hopper into a hammer action and a grinding action, the material then passing through a sieve plate (the sieve plates can be varied in size).

To ensure uniformity the raw herbs are fed through the mill in a steady way.  Bags are filled and repalced in timely manner (taking samples from each bag for QC checks).  Each bag is identified by product name, code and batch number before being weighed and sealed. 

At the end of milling the entire cleaning procedure must be repeated.

At every stage inspections take place to ensure that GMP requirements are being followed. 

A quality-driven organisation

Herbs in a Bottle is a quality-driven organisation, and this is especially reflected in the way we seek out high-quality raw materials and continuously enhance our production techniques and specifications.

We recognise that quality is a total concept. Among the many aspects we consider when looking at our overall quality commitment are:

• Cleanliness and hygiene
• Selection of raw materials
• Organic vs. non organic issues
• Fresh vs. dried issues
• Extraction techniques
• Active components
• Energetics and feel
• Packaging

All of the above, combined with the philosophy and integrity of the company, go to make up our Quality Policy.

The Environment

We aim to be an environmentally responsible company. Herbs in a Bottle recognises that the plants we use are a valuable natural resource and that some of our plants are under severe environmental pressure due to indiscriminate gathering and over-harvesting. Herbs in a Bottle is a strong supporter of organic cultivation and the investigation of cultivation techniques for herbs which are difficult to grow.

When one percolates a tincture or fluid extract, the solvent is in continuous motion against the plant material, maintaining a concentration gradient throughout the process. This allows for the greater extraction of those vital plant ingredients, and leads to less waste of our valuable herbal resources.

Essential oils

We offer our customers a range of sixty-four Essential Oils.

The majority of Herbs in a Bottle Oils are concentrated hydrophobic liquids steam distilled from raw plant material (flowers, leaves, wood, bark, roots, seeds or peel). A very small number are produced using other extraction methods.

In almost all cases the oils are distilled in a single process.  Essential Oils can vary according to a number of
factors including botanical origin, geographical origin, specific characteristics and individual chemotypes. Our aim is to supply you with a standardised product that conforms to therapeutic standards.

In the absence of any legally enforceable “therapeutic standard” for Essential Oils the following criteria have been observed:

• Gas spectrometry reports for each oil are reviewed.
• All oils are first distillation unless (in exceptional cases) the raw plant material dictates otherwise - for instance ylang ylang.
• All oils list Latin botanical names as well as the common name.
• All oils are packaged in dark opaque bottles to neutralise susceptibility to heat, light, and air.
• Other information such as extraction methods, specific gravity, and optical rotation is available on request.

Recent advances in chemistry have flooded the market with synthetic essential oils which have little therapeutic value. Our Essential Oils are guaranteed to be pure extracts with no added synthetic materials. None of the chemical constituents have been removed. The oil is never “stretched” by adding oil from cheaper plants. You may call for the gas chromatographs of any batch which will show the various organic components which make up each specific oil. All batches have complete traceability.

Remember, generally Essential Oils should not be applied directly to the skin because of their undiluted form. A range of Carrier Oils is available for blending with Essential Oils. A number of Essential Oils can cause severe irritation or allergic reaction, and practitioners should consult the appropriate references on material safety.

Special terms for newly-qualified practitioners

All graduates from training programmes recognized by the European Herbal Practitioners Association may participate in our start-up programme.

Simply place your order with us (minimum £500) and pay for the whole order less a 25% discount, plus two further discounts for £25 each redeemable against your second and third orders (minimum order for each these two subsequent discounts is £100).

Remember that if your order is over £200 carriage is free.

Redeemable against any of our products. These special terms are for telephone orders only and are not available via our website. Only one start-up per graduate.

The Way Ahead

As herbal medicine manufacturers we have decided that the only way we are going to survive in a demanding world is to put our company on the firmest foundations possible. A tremendous pace of investment and expansion at our Essendine facility has commenced with the aim of securing herbal medicine production far into the future. Our Technical department is rightly acclaimed in the industry as a highly professional department able to respond to the most stringent demands of medicines legislation. To further strengthen this department we have appointed Steve Williams as Technical Director. Steve has thirty years’ experience in the pharmaceutical industry and will enable us to put herbal medicine production on a level of excellence equal to that of conventional medicines.

Diversification has taken place within Herbs in a Bottle and we now carry out very substantial New Product Development (NPD) and contract manufacture – all within the CAM sector. This has revolutionised the options for practitioners wanting to develop their own ranges of medicines.

Come and see for yourself

Blending Suite, Wet Rooms, Capsule Rooms, Technical and NPD facilities, specialist warehousing, bespoke storage areas and many more features make our Essendine factory one of the biggest and newest herbal medicine manufacturing facilities in the world, fully compliant with GMP. Come and see our production areas for yourself – we welcome visits by groups of practitioners and welcome your feedback on how we are doing.