10.5 LIMITS FOR MICROBIAL CONTAMINATION -

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Thai Herbal Pharmacopoeia

สำนักยาและวัตถุเสพติด กรมวิทยาศาสตร์การแพทย์ กระทรวงสาธารณสุข

Bureau of Drug and Narcotic, Department of Medical Sciences, Ministry of Public Health

10.5 LIMITS FOR MICROBIAL CONTAMINATION

In the manufacturing, packaging, storage and distribution of pharmaceutical preparations, suitable means must be taken to ensure their microbiological quality. Unless otherwise specified in the individual monograph, the non-sterile pharmaceutical preparations should comply with the acceptance criteria given in Table 1, and the herbal drug preparations should comply with the acceptance criteria given in Table 2. Tables 1 and 2 include a list of specified micro-organisms for which acceptance criteria are set. The list is not necessarily exhaustive and for a given preparation it may be necessary to test for other micro-organisms depending on the nature of the starting materials and the manufacturing process.

Table 1 Acceptance Criteria for Microbiological Quality of Non-sterile Pharmaceutical Preparations

Category	Types	Requirements*
1	Topical preparations for broken skins, abscess, lesions, and mucous membranes excluding vaginal and rectal routes	- Total aerobic microbial count: not more than 2 × 10² CFU per g or per mL and total combined yeasts and moulds count: not more than 2 × 101 CFU per g or per mL. - Absence of Pseudomonas aeruginosa and Staphylococcus aureus per g or per mL
2	A. Preparations for inhalation use (Applied to liquid preparations for nebulization)	- Total aerobic microbial count: not more than 2 × 10² CFU per g or per mL and total combined yeasts and moulds count: not more than 2 × 10¹ CFU per g or per mL. - Absence of bile-tolerant gram-negative bacteria, Pseudomonas aeruginosa and Staphylococcus aureus per g or per mL.
	B. Preparations for vaginal use	- Total aerobic microbial count: not more than 2 × 10² CFU per g or per mL and total combined yeasts and moulds count: not more than 2 × 10¹ CFU per g or per mL. - Absence of Pseudomonas aeruginosa, Staphylococcus aureus and Candida albicans per g or per mL.

*Carry out the tests as described in the “Microbial Limit Tests” (Appendix 10.2).

Table 1 (continued)

Category	Types	Requirements*
2	C. Preparation for rectal use	- Total aerobic microbial count: not more than 2 × 10³ CFU per g or per mL and total combined yeasts and moulds count: not more than 2 × 10² CFU per g or per mL.
	D. Preparations for nasal use (Applied to liquid, semi-solid or solid preparations for administration to the nostrils)	- Total aerobic microbial count: not more than 2 × 10² CFU per g or per mL and total combined yeasts and moulds count: not more than 2 × 10¹ CFU per g or per mL. - Absence of Pseudomonas aeruginosa and Staphylococcus aureus per g or per mL.
	E. Preparations for auricular, gingival and oromucosal use	- Total aerobic microbial count: not more than 2 × 10² CFU per g or per mL and total combined yeasts and moulds count: not more than 2 × 10¹CFU per g or per mL. - Absence of Pseudomonas aeruginsa and Staphylococcus aureus per g or per mL.
3	Transdermal patches and topical preparations for intact skin, e.g., creams, lotions, ointments, solutions, powders, etc.	- Total aerobic microbial count: not more than 2 × 10² CFU per g or per mL or per patch and total combined yeasts and moulds count: not more than 2 × 10¹ CFU per g or per mL or per patch. - Absence of Pseudomonas aeruginosa and Staphylococcus aureus per g or per mL or per patch.
4	A. Aqueous preparations for oral use	- Total aerobic microbial count: not more than 2 × 10² CFU per g or per mL and total combined yeasts and moulds count: not more than 2 × 10¹CFU per g or per mL. - Absence of Escherichia coli per g or per mL

*Carry out the tests as described in the “Microbial Limit Tests” (Appendix 10.2).

Table 1 (continued)

Category	Types	Requirements*
	B. Non-aqueous preparations for oral use	- Total aerobic microbial count: not more than 2 × 10³ CFU per g or per mL and total combined yeasts and moulds count: not more than 2 × 10²CFU per g or per mL. - Absence of Escherichia coli per g or per mL
5	Preparations for oral administration containing raw materials of natural origin (animal, vegetable or mineral) which cannot be treated with a process for reduction of microbial count**	- Total aerobic microbial count: not more than 2 × 10⁴ CFU per g or per mL and total combined yeasts and moulds count: not more than 2 × 10²CFU per g or per mL. - Bile-tolerant gram-negative bacteria: not more than 10²probable number of bacteria per g or per mL. - Absence of Staphylococcus aureus and Escherichia coli per g or per mL. - Absence of Salmonella spp. per 10 g or per 10 mL.

*Carry out the tests as described in the “Microbial Limit Tests” (Appendix 10.2).
**Specified for raw materials of natural origin that are not obtainable with the required purity including those for manufacturing drugs where an antimicrobial treatment (e.g., with ethylene oxide or ionizing radiations) is not feasible or permissible. The examples are arabic gum, tragacanth, pancreas powder, pepsin, and trypsin

Table 2 Acceptance Criteria for Microbiological Quality of Herbal Drug Preparations

Category	Types	Requirements*
1	Preparations from crude drug extracts which underwent a process for reduction of micro-organisms: A. Preparations for oral use	- Total aerobic microbial count: not more than 5 × 10⁴ CFU per g or per mL and total combined yeasts and moulds count: not more than 5 × 10²CFU per g or per mL. - Bile-tolerant gram-negative bacteria: not more than10²probable number of bacteria per g or per mL. - Absence of Escherichia coli per g or per mL. - Absence of Salmonella spp. per 25 g or per 25 mL.
	B. Topical preparations for intact skin	- Meet the requirements stated in Table 1 Category 3.
2	Preparations of crude drugs and mixtures of crude drugs for internal use which will undergo a process for reduction of microbial count before use (e.g., by pouring boiling water over them)	- Total aerobic microbial count: not more than 5 × 10⁷ CFU per g or per mL and total combined yeasts and moulds count: not more than 5 × 10⁵CFU per g or per mL. - Escherichia coli: not more than 10³ CFU per g or per mL. - Absence of Clostridium spp. per g or per mL. - Absence of Salmonella spp. per 25 g or per 25 mL.
3	Preparations for external use of crude drugs and mixtures of crude drugs A. Applied to herbal compress (LUK PRAKHOP)	- Total aerobic microbial count: not more than 5 × 10⁷ CFU per g or per mL and total combined yeasts and moulds count: not more than 5 × 10⁵CFU per g or per mL. - Absence of Pseudomonas aeruginosa, Staphylococcus aureus and Clostridium spp. per g or per mL.
	B. Applied to others, i.e., herbal inhalant (YAA DOM SAMUN PHRAI), herbal insufflation (YAA NAT)	- Meet the requirements stated in Table 1 Category 3.

*Carry out the tests as described in the “Microbial Limit Tests” (Appendix 10.2).

Table 2 (Continued)

Category	Types	Requirements*
4	Other preparations for internal use containing whole or ground crude drugs	- Total aerobic microbial count: not more than 5 × 10⁵ CFU per g or per mL and total combined yeasts and moulds count: not more than 5 × 10⁴ CFU per g or per mL. - Bile-tolerant gram-negative bacteria: not more than 10² probable number of bacteria per g or per mL. - Absence of Escherichia coli and Clostridium spp. per g or per mL. - Absence of Salmonella spp. per 25 g or per 25 mL.

*Carry out the tests as described in the “Microbial Limit Tests” (Appendix 10.2).

APPENDICES • 10.5 LIMITS FOR MICROBIAL CONTAMINATION

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ตำรามาตรฐานยาสมุนไพรไทย

Thai Herbal Pharmacopoeia

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10.5 LIMITS FOR MICROBIAL CONTAMINATION