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.

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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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