Liquids, creams, and ointments are susceptible to microbial and other contamination during manufacture. Special measures must be taken to prevent contamination, including using closed processing and transfer systems, effective ventilation of production areas, and readily cleanable tanks and equipment made of high-quality stainless steel. Water quality must be specified, monitored, and sanitization procedures validated. Materials received and transferred must be checked for quality and delivered to the correct destination to prevent contamination of products or clean containers. Mixing and filling processes must be validated and special care taken at start, stop, and end of filling. Storage conditions of unfinished products must be specified if not immediately packaged.

1. MANUFACTURE OFMANUFACTURE OF
LIQUIDS, CREAMS ANDLIQUIDS, CREAMS AND
OINTMENTSOINTMENTS
PIC/S Annex 9PIC/S Annex 9

2. PRINCIPLEPRINCIPLE
• Liquids, creams and ointments may be
susceptible to microbial and other
contamination during manufacture.
Therefore special measures must be taken
to prevent any contamination.
2

3. PREMISES ANDPREMISES AND
EQUIPMENTEQUIPMENT
• to protect the product from contamination,
closed systems of processing and transfer is
recommended.
• production areas where products or open
clean containers are exposed should be
effectively ventilated with filtered air.

4. PREMISES ANDPREMISES AND
EQUIPMENTEQUIPMENT
• Tanks, containers, pipework and pumps
should be readily cleaned and if necessary
sanitised.
• The use of glass apparatus should be avoided
wherever possible. Use high quality stainless
steel for product contact parts.

5. PREMISES ANDPREMISES AND
EQUIPMENTEQUIPMENT
• Water System:
– Specify and monitor the chemical and
microbiological quality of water.
– Maintenance be made in order to avoid the risk of
microbial proliferation.
– Follow a validated flushing procedure to ensure
that the sanitising agent has been effectively
removed after any chemical sanitization

6. PRODUCTIONPRODUCTION
• Check quality of materials received in bulk
tankers before they are transferred to bulk
storage tanks.
• Ensure that when transferring materials via
pipelines, they are delivered to their correct
destination.
• Materials likely to shed fibres or other
contaminants should not enter the areas
where products or clean containers are
exposed.

7. PRODUCTIONPRODUCTION
• Ensure 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.

8. PRODUCTIONPRODUCTION
• When finished product is not immediately
packaged, the maximum period of storage
and the storage conditions should be specified
and respected.

9. Remember this…
• Liquids, creams and ointments may be
susceptible to microbial and other
contamination during manufacture. Therefore
special measures must be taken to prevent
any contamination.

10. Liquid, Creams and Ointments Quiz
1. Glass apparatus should be avoided in
production because
A. It breaks and may contaminate the product
B. it is cheap
C. it needs to be calibrated

11. Liquid, Creams and Ointments Quiz
2. True or False. When product is not
immediately filled into the container, the
maximum period of storage and the storage
conditions should be specified and respected.
3.Product contact parts should be made of
_____________________.

12. Liquid, Creams and Ointments Quiz
4. True or False. Mixing tanks and apparatus
should be readily cleaned.
5. True or False. Materials likely to shed fibres or
other contaminants should not enter the areas
where products or clean containers are exposed.

13. THANK YOU