Microbial quality standards

All finished products are tested for sterility in a controlled-access clean room environment in a laminar flow hood, which provides no greater level of a microbial challenge than that encountered in the fill environment. The testing environment consists of a gowning room and sterility test suite that meets the same air quality standards as the hlling suite. 

Appropriate specifications for chemical and microbial quality should be established and periodic testing conducted. Such specifications will vary depending on the process and the point in the process when the water is used. The water quality standards should reflect the intended use of the excipient The frequency of microbial and chemical testing of purified water is dependent upon a variety of factors including the test results and the point in the process (e.g., final wash in centrifuge) at which such water is used. 

Independent of the specific national drug regulations for countries around the world, there is also an international consensus that all TCM drugs must meet certain, stipulated high-quality standards. Additionally, it must be guaranteed that all TCM drugs prescribed by physicians are safe for patients. The safety proof aims mainly to exclude any kind of possible falsifications of the herbal drugs and the limitation of concentrations of heavy metals, aflatoxins and defined microbial adulterations. 

Recognizing these problems, UK food regulatory authorities have generally abandoned the use of quantitative microbial counts as enforceable standards of food quality. Despite this, the European Pharmacopoeia has introduced both quantitative and qualitative mierobial standards for non-sterile medicines, which might become enforceable in some member states. It prescribes varying maximum total microbial levels and exclusions of particular species according the routes of administration. The British Pharmacopoeia has now ineluded these tests, but suggest they should be used... 

Several guidelines are available in the literature for the pharmacist who must extemporaneously prepare an ophthalmic solution. The USP contains a section on ophthalmic solutions, as do other compendia and several standard textbooks. Since the pharmacist does not have the facilities to test the product, he or she should dispense only small quantities, with an expiration date of no more than 30 days. Refrigeration of the product should also be required as a precautionary measure. To reduce the largest potential source of microbial contamination, only sterile purified water should be used in compounding ophthalmic solutions. Sterile water for injection, USP, from unopened IV bottles or vials is the highest-quality water available to the pharmacist. Prepackaged sterile water with bacteriostatic agents should not be used. 

Ashbolt N, Grabow WOK, Snozzi M (2001) Indicators of microbial water quality. In Fewtrell L, Bartram J (eds) Water quality guidelines standards and health assessment of risk and risk management for water-related infectious disease. IWA Publishing, London, pp 289-316... 

Compatibility and safety for topical delivery systems are addressed in the same manner as for topical drug products. Performance and quality control should be addressed for the rate-controlling membrane. Appropriate microbial limits should be established and justified for each delivery system. Microbiological standards are under development therefore, the review division for a specific application should be consulted. 

Sterile products have several unique dosage form properties, such as freedom from micro-organisms, freedom from pyrogens, freedom from particulates, and extremely high standards of purity and quality however, the ultimate goal in the manufacture of a sterile product is absolute absence of microbial contamination. The emphasis of this chapter will be the validation of the sterilization processes responsible for achieving this goal. 

Water is the base for many biological life forms, and its safety in pharmaceutical formulations is unquestioned provided it meets standards of quality for potability and microbial content see Sections 9 and 18. Plain water is considered slightly more toxic upon injection into laboratory animals than physiological salt solutions such as normal saline or Ringer s solution. 

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