Aseptic processing is performed in a validated Class 100 clean room with HEPA (High Efficiency Particulate Air) filtration to maintain sterility of the products and prevent contamination by micro-organisms and particulate matter.
The staff have been trained in aseptic techniques and strictly adhere to this code of practice. Accurate and detailed records are kept for each product processed. A quality assurance programme is in place to evaluate the equipment, personnel and facility. Microbiological testing and clean room (Class 100) status validation and verification are conducted annually.
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Full documentation of each process is carried out according to standardized procedures.
All processes are done in accordance with authorized SOP's (Standard Operating Procedures) for :
- Appropriately trained personnel
- Adequate premises and space
- Suitable equipment and services
- Correct materials containers and labels
- Approved procedures
Suitable storage and transport of the medication
A system is in place to recall any batch or product should it be necessary.
High standards of hygiene are observed by all of those involved with the processing of compounded prescription medicines.
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