The Sterile Area

In particular, aseptic processing is carried out in a sterile room with HEPA (High Efficiency Particulate Air) filtration with a class 100 status (validated) and clean room environment to maintain sterility of the products and prevent contamination of 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 which includes microbiological testing and clean room (Class 100) status validation and verification.

Full documentation of each process is carried out according to standardised procedures.

Processing is done under the direct supervision of a pharmacist as per the applicable legislation.

All processes are done in accordance with SOP’s (Standard Operating Procedures) authorised by a pharmacist as per the above mentioned guidelines and all necessary requirements are provided 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