Presentation Slides from Gilchrist Technical Services Ltd. Alastair Gilchrist-Speaker
Gilchrist Technical Services Ltd.
Test result from a batch of cosmetic
product contaminated with mould.
Photograph used by kind permission of Southern Microbiological Services Limited
The 10 Golden Rules Of GM
- Get the facility and equipment design right from the start.
- Practice good hygiene.
- Write good procedures and follow them.
- Identify who does what.
- Train and develop staff.
- Validate processes.
- Keep good records.
- Maintain facilities and equipment.
- Build quality into the whole product lifecycle.
- Perform regular audits an implement improvements identified.
- Design a good logical material flow through the facility.
- Specify the finishes in each area:
- Appropriate to the activity being carried out.
- Which are easy to keep clean and to maintain.
- Ensure that there are changing, hand washing andmessing facilities outside the production areas.
- Provide appropriate storage conditions for the materials,components sub- assemblies and finished products.
- Where possible locate utilities outside production areas.
- Implement and monitor appropriate pest control programmes.
- Specify and use hygienic equipment.
- Suitable materials of construction.
- Appropriate surface finishes.
- Fully drainable.
- Crevice free.
- Capable of being cleaned and sanitised.
- Write a microbiological control strategy and ensure thatyour equipment design and configuration fits with yourstrategy.
- Minimise the number of operational steps. Make – Fill – Pack
- People are your biggest asset.
- Choose them carefully and reward them appropriately.
- Define their roles and make sure that they understand:
- What they have to do.
- How to do their tasks.
- How to record their work.
- Why they have to follow procedures and training.
- Ensure that personnel have the right tools and resources to do thejob.
- Train and develop personnel.
- Tasks can always be done better and improvements should beimplemented.
Microbiological Control Strategy
The war against microorganisms is one which will never be won. Each batch of product is a battle which must be won to ensure the safety andperformance of the product.
- Define how equipment will be cleaned.
- Define how equipment will be sanitised.
- Ensure that the interfaces between equipment is notforgotten e.g. the hose that links the mixer or storagecontainer to the filling machine.
- Document your requirements.
- Write procedures.
- Validate that the procedures meet your requirements.
Raw Materials – the building blocks of cosmetics
- Ensure that appropriate raw materials are used.
- Agree specifications with suppliers.
- Make sure that the specification includes a microbiology limit.
- If the material is known to be hostile to micro organisms e.g. ethanol orsodium hydroxide the specification can be “Not required”
- If raw materials are particularly susceptible tomicrobiological contamination consider basingbatch sizes on full packs.
- Only handle bio-critical raw materials in clean productionareas by trained staff using appropriate sanitised equipment.
- Ensure that part containers of raw materials are re-sealedand stored in an appropriate location.
- Test materials which are susceptible to microbiologicalcontamination.
Water –the most important raw material
- Most cosmetic products which require preservation contain water.
- Water is also the most commonly used medium for cleaning.
- Hot water can be used to sanitise equipment.
- If chemical sanitisation is used water will be required toremove traces of sanitising chemicals.
- City water is not normally considered suitable for makingcosmetic because:
- The quality can be variable [depending on source and/or season] it is not underyour control.
- The water is not purified to remove salts or organic materials.
- Additives such as chlorine or fluoride are often added.
- Purified water to a defined specification should be used toensure consistent product quality and that unacceptable levels of microorganisms are not introduced to the product.
Purified Water Specification
Define the water quality required.
• Install a system to produce and store water of the required quality.
• Test the water periodically to ensure that it meets the required quality.
• Purchase purified water.
• Use full containers on day of opening or dispose of remains.
Clean – no traces of any previous products or cleaning products apart frompurified water.
- Manual – difficult to validate as it is operator dependent.
- CIP – cleaning in place good option for larger items. Easy tovalidate.
- Off-line – dismantle items and clean in a parts washer.Easy to validate. Sanitisation – reduction of viable microorganismsto undetectable levels.
- Hot purified water [> 80°C for > 10 minutes]. No residues. Norinsing.
- Chemical sanitisation. All traces of sanitisers need to beremoved before production starts – creates effluent.Sanitisers need to be rotated.
Sanitisation needs to take place just before production especially if equipment is notdried.
Testing and Validation
Preservative Efficacy Test [PET] or challenge test – every cosmetic product must be assessed to ensure that the preservative system is robust unless itis hostile to micro organisms.
Total Viable Count [TVC] testing should be carried out on:
- Every batch of bio-critical cosmetic product produced.
- Bio-critical raw materials which could contribute to thebioburden of the product [including purified water].
- Correct validated test methodsshould be used. Validation of Processes
- Processes can be validated to reduce testing frequency.
- Testing of validated processes must be continued on an auditbasis.
Introduction to Cosmetics Preservation with Green Chemistry 12
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