Principle
Liquids, creams and ointments may be particularly susceptible to microbial and other
contamination during manufacture. Therefore special measures must be taken to prevent any contamination.
Premises and equipment
- The use of closed systems for processing and transfer is recommended in order to protect the product from contamination. Production areas where the products or open clean containers are exposed should normally be effectively ventilated with filtered air.
- Tanks, containers, pipework and pumps should be designed and installed so that they may be readily cleaned and if necessary sanitised. In particular, equipment design should include a minimum of dead-legs or sites where residues can accumulate and promote microbial proliferation.
- The use of glass apparatus should be avoided wherever possible. High quality stainless steel is often the material of choice for parts coming into contact with product.
Production - The chemical and microbiological quality of water used in production should be specified and monitored. Care should be taken in the maintenance of water systems in order to avoid the risk of microbial proliferation. After any chemical sanitisation of the water systems, a validated flushing procedure should be followed to ensure that the sanitising agent has been effectively removed.
- The quality of materials received in bulk tankers should be checked before they are
transferred to bulk storage tanks. - Care should be taken when transferring materials via pipelines to ensure that they are delivered to their correct destination.
- Materials likely to shed fibres or other contaminants, like cardboard or wooden pallets, should not enter the areas where products or clean containers are exposed.
- Care should be taken to maintain the homogeneity of mixtures, suspensions, etc. during filling. Mixing and filling processes should be validated. Special care should be taken at the beginning of a filling process, after stoppages and at the end of the process to ensure that homogeneity is maintained.
- When the finished product is not immediately packaged, the maximum period of storage and the storage conditions should be specified and adhered to.