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Pharmaceutical Manufacturing and Packing Sourcer

Regulating Sterility

The implementation of USP 797, which is an FDA-enforceable Directive, will have a major impact on any facility involved in the preparation, storing and dispensing of sterile preparations, as Harry Kirk of Nitritex explains in his summary of the facilities requirements

Before assessing the implications of this section of USP 797, it is important to understand exactly the requirements of the Directive and the facilities to which it applies. Facilities affected by USP 797 include healthcare institutions, pharmacies and physician practice facilities. Areas where sterile products are prepared and where manipulations are performed during the compounding of sterile products which increase the potential for microbial contamination of the end product will also be affected, as will those where products are compounded using devices or ingredients which are not sterile to prepare products that must be sterilised prior to use. The products affected include diagnostics, drugs, biologics, nutrients and radiopharmaceuticals (baths and soaks for live organs and tissues, implants, inhalations, injections, irrigations, metered sprays, ophthalmic and OTC preparations). There are three microbial contamination risk levels identified.

LOW RISK

These are sterile facilities with air quality at ISO Class 5 (EU GMP Grade A/B) or better using only sterile ingredients, products, components and devices:

  • 48 hours at room temperature
  • 14 days at cold temperature
  • 45 days in a solid frozen state at -25ºC 70 -10ºC

MEDIUM RISK

Where compounding may require a long duration for sterile products that will be administrated to multiple patients or to one patient on multiple occasions. For medium risk preparations, and in the absence of passing a sterility test, the storage period cannot exceed the following times:


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Educated at Durham University, Harry Kirk has held senior management positions in a number of multinational life science companies. He lived in the Far East for 10 years, managing a cleanroom glove manufacturing facility before returning to the UK in 1990 as Sales & Marketing Director of a UK-based healthcare supplies company. In 1996 he co-founded Nitritex Ltd, a company specialising in the supply of cleanroom consumables. He is currently Business Development Director of the company with responsibility for new product and market development.
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