Sterile preparation must be free from contamination with microorganisms.

a) Name THREE sterilization methods that are commonly used in the pharmaceutical industry. What are the priniciples of these methods?

(9 marks)

b) The sterile production unit must be separated from the general manufacturing area within the hospital pharmacy or factory. Describe the basic cleanroom requirements. (3 marks)

c) Isolators may be used for small-scale aseptic processing of sterile products. Briefly describe how isolators should be tested to ensure they conform with the required level for its purpose. (3 marks)