Sterilisation guidelines

Validation studies for gas sterilisation should be conducted following the guidelines of Appendix E (see also Contract Manufacture) and should include ... 

Production from National Production and filling class D if starting materials guideline terminally sterilised (regular pharmacy production) Every batch Environmental monitoring biobnrden endotoxins Product dossier with validation data on production and QC... 

Purified water can also be purchased. In that case Sterile purified water or Sterilised water for injections is recommended because of the insecure shelf life and usage period of non-sterile water. Table 23.8 provides practical, not official, guidelines for keeping water in small-scale situations without a storage and distribution installation. 

Classical sterilisation techniques using an autoclave and saturated steam under pressure, hot water or dry heat are practical and reliable. Other reliable sterilisation methods include membrane filtration, ionising radiatirm sterilisation (gamma and electron-beam radiation) and gas sterilisation (ethylene oxide, formaldehyde). Sterilisation equipment (autoclaves, membrane filters, and other sterilisers) is often used in industrial manufacturing, in preparation in pharmacies, and in other healthcare establishments. Standard sterilisation processes are described in the Ph. Eur., in other current Pharmacopoeias, in ISO standards and National guidelines. 

At present, there are no specific guidelines or rules for the sterilisation of freeze-drying systems. However, to ensure a sterilisation compliant with cGMP, sterilisation with saturated steam at a temperature of >121.1 °C corresponding to a saturated vapour pressure of >2.5 bar abs. has become widespread in practice. 

Clear up body fluids promptly and disinfect surfaces appropriately Dispose of all contaminated waste safely according to local guidelines, including how to dispose of soiled linen Clean, disinfect and sterilise equipment as appropriate... 

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