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TGA Laboratories' guidelines for assessing the results of microbiological tests on non-sterile pharmaceuticals for human use

7 November 1994

Although this document is dated November 1994, it is still valid and can be used until 1 January 2010. As of 1 January 2010, Therapeutic Goods Order No. 77 Microbiological standards for medicines <http://www.tga.gov.au/legis/tgo/tgo77.htm> will specify the minimum microbiological requirements with which a medicine must comply throughout its shelf life.

Category Type of Preparation Suggested Limit
1 Products for Topical Application (including those for use in body cavities)
1a For use on broken* and unbroken skin (other than antiseptics and corticosteroids)

TAMC** not more than 102 per mL or per gram amongst which there should be

  • no pseudomonads
  • no Staphylococcus aureus
1b Antiseptics and corticosteroids

TAMC** not more than 10 per mL or per gram amongst which there should be

  • no pseudomonads
  • no Staphylococcus aureus
2 Products for Oral Use
2a Products other than those containing raw material of vegetable or animal origin

TAMC** not more than 103 per mL or per gram amongst which there should be

  • not more than 102 yeast and mould
  • not more than 102 enterobacteria
  • no E coli in 1mL or 1g
  • no salmonellae in 10mL or 10g
2b Products containing raw materials of vegetable or animal origin

TAMC** not more than 104 per mL or per gram amongst which there should be

  • not more than 102 yeast and mould
  • not more than 102 enterobacteria
  • no E coli in 1mL or 1g
  • no salmonellae in 10mL or 10g
2c Herbal teas

TAMC** not more than 105 per gram amongst which there should be

  • not more than 102 yeast and mould
  • not more than 102 enterobacteria
  • no E coli in 1mL or 1g
  • no salmonellae in 10mL or 10g

* "broken skin" refers to minor cuts and abrasions; products intended for use on large open wounds or severely damaged skin should be sterile.

** Total Aerobic Microbial Count

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