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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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.

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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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.

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Our website:  www.herbsinabottle.com

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.

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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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.