Last Amended on - Page 1 of 14 I. DRUGS & PHARMACEUTICALS 1. Biological Assays Antibiotics And Other Drugs Bulk Drugs & Their Formulations: Erythromycin, Gentamicin, Nystatin IP Appendix 9.1 2.2.10 BP Appendix XIVA (EP 2.7.2), USP <81> Upto 100% 2. Sterility Tests a. Canned Foods (Commercial) Sterility APHA Chapter-61, 61.51 (Pass/Fail) b. Hospital Ware, Surgical Items, Pharmaceuticals, Drugs & Cosmetics Sterility IP Appendix 9.5, BP Appendix XVIA, (EP 2.6.1), USP <71> (Pass/Fail) 3. Microbiological Tests Microbial Limit Tests Total Aerobic Microbial Count/ Viable Bacterial Count Yeast & Mold Count IP Appendix 9.4, 2.2.9 BP Appendix XIVB, XVIB (EP 2.6.12) USP <61> 1 CFU/ ml 10 CFU/ g 1 CFU/ ml 10 CFU/ g Escherichia coli IP Appendix 9.4, 2.2.9 Enterobacteriaceae & Other Gram Negative Bacteria Pseudomonas aeruginosa BP Appendix XIVB, XVIB (EP 2.6.13) USP <62 Detection/1 ml or 1g 10 to 1000 CFU/ g/ ml Detection/1 ml or 1 g
Last Amended on - Page 2 of 14 Staphylococcus aureus Detection/1 ml or 1 g Salmonella Detection/10 ml or 10g Clostridia IP Appendix 9.4, 2.2.9 Candida albicans Bile Tolerant Gram Negative Bacteria BP Appendix XIVB, XVIB (EP 2.6.13) USP <62 Detection/1 ml or 1 g Detection/1 ml or 1 g Detection/1 ml or 1 g Antimicrobial Effectiveness Test IP Appendix 9.2, 2.2.2 BP Appendix XVIC (EP 5.1.3) USP <51> (Complies/Does not complies) II. Bacterial Endotoxins Test (LAL Test) COSMETICS & ESSENTIAL OILS 1. Skin creams / Liquid foundation make-up/ Hair oils / Liquids, Solids, Powders, Creams and Oil Based Total viable count Total viable count IP Appendix 2.3, 2.2.3, BP Appendix XIVC (EP 5.1.3, EP 2.6.14), USP <85> IS 14318: 1996 IS 7123: 1993 (Complies/Does not complies) 10 CFU/ g/or ml Minimum. 10 microorganisms / g or ml Aerobic plate count FDA-BAM,Chapter 23 < 1 CFU/ ml <10 CFU/g Yeasts & mold plate count Anaerobic plate count < 1 CFU/ ml < 10 CFU/g < 1 CFU/ ml < 10 CFU/g
Last Amended on - Page 3 of 14 Skin creams / Liquid foundation make-up/ Hair oils / Liquids, Solids, Powders, Creams and Oil Based Total microbial count (bacterial and fungal count) IS 14648: 2011 < 1 CFU/ ml < 10 CFU/g Gram negative pathogens IS 14648: 2011 (Presence/Absence) Staphylococcus aureus (for baby products) IS 14648: 2011 (Presence/Absence) III. FOOD & AGRICULTURAL PRODUCTS 1. Alcoholic Drinks Coliforms IS 3752: 2005 < 1 CFU/ ml 2. Sugar & Sugar Bacterial count IS 5402: 2012/ ISO 4833: 2003 GS2/3-41: 1994 GS2/3-43: 1994 GS2/3-45: 2002 Coliforms IS 5401(Part 1): 2002/ ISO 4832: 1991 IS 5401(Part 2): 2012/ ISO 4831: 2006 Yeasts & Molds IS 5403: 1999/ GS2/3-47: 1998 < 1 CFU/ ml < 10CFU/g/ ml <0.30MPN/ ml or g < 1 CFU/ ml < 10 CFU/g/ ml < 1 CFU/ ml < 10 CFU/g/ ml Escherichia coli IS 5887(Part 1): 1976 Detection/1 ml or1g <0.30 MPN/ ml or g
Last Amended on - Page 4 of 14 Sugar & Sugar Salmonella IS 5887(Part 3): 1999 ISO 6579:2002, 10g/ ml,250g/ ml Shigella IS 5887(Part 7): 1999, 10g/ ml,250g/ ml 3. Non-Alcoholic Drinks Bacterial Count IS 5402: 2012/ ISO 4833: 2003 FDA-BAM, Chapter 3; Compendium APHA (4 th Edition) Chapter 7-7.6 Coliforms IS 5401(Part 1): 2002/ ISO 4832: 1991, IS 5401(Part 2): 2012/ ISO 4831: 2006 IS 3752: 1988, IS 15185: 2002/ ISO 9308-1, FDA-BAM Chapter 4; APHA Chapter 8-8.7 Escherichia coli IS 5887 (Part 1): 1976 FDA-BAM Chapter 4, Enterococci IS 5887 Part 2: 1976/ IS 15186: 2002 <1 CFU <0.30-110-110 MPN/ ml or g, Detection/100 ml or 200 ml 0/100 ml Detection/1 ml,10 ml <0.30-110-110 MPN/ml <10 CFU/g ml or <100 CFU// ml, <1 CFU/ ml or Detection/100 ml or 200 ml/250 ml MPN/ ml
Last Amended on - Page 5 of 14 Non-Alcoholic Drinks Yeasts & Molds IS 5403: 1999/ FDA-BAM Chapter.18, APHA Chapter 20-20.51, 20.53 <1 CFU/ ml or Detection/ 200 ml/250 ml Pseudomonas aeruginosa IS 13428: 2005 Annexure D Staphylococcus aureus IS 5887(Part 2): 1976; IS 5887(Part 8/ Sec I & II): 2002 FDA-BAM, Chapter 12 Salmonella IS 5887(Part 3): 1999, IS 15187: 2002/ ISO 6340: 1995, FDA-BAM, Chapter 5 Shigella IS 5887(Part 7): 1999, FDA-BAM, Chapter 6 Detection/50 ml <10 CFU/ ml & Detection/100 ml or 200 ml or ml or 25 ml Detection/100 ml or 200 ml or25 ml or ml Detection/100 ml or 200 ml or 25 ml Sulphite reducing anaerobes (Clostridia) IS 13428: 2005, Annexure C Detection/50 ml Vibrio cholerae IS 5887 (Part 5): 1976 25 ml or 25g Vibrio parahaemolyticus IS 5887 (Part 5): 1976 25 ml or 25g Costridium perfringens IS 5887 (Part 4): 1999 Detection/25 ml Test for Commercial Sterility APHA Chapter 61-61.51 (Complies/Not complies)
Last Amended on - Page 6 of 14 4. Milk & Dairy Microbial Count IS 5402: 2012/ ISO 4833: 2003, <10 CFU/g Yeast &Mold Count IS 5403: 1999/, <10 CFU/g Escherichia coli IS 5887(Part 1): 1976, Detection/1 ml or g <100 CFU/g/ ml, <0.30-110 MPN/ g / ml Coliforms IS 5401(Part 1): 2002/ ISO 4833: 1991 IS 5401(Part 2)/ ISO 4831: 2006 APHA Chapter 8-8.7 FDA BAM Chapter 4 <0.30-110 MPN/ ml or g, <1 CFU/ ml <10 CFU/ g/ ml Salmonella IS 5887(Part 3): 1999; ISO 6579: 2002 Shigella FDA BAM Chapter 5, APHA Chapter 37-37.123,124,125,126 IS 5887 (Part 7): 1999, FDA BAM Chapter 6, APHA Chapter 38-38.23,24,25 Vibrio cholerae& Vibrio parahaemolyticus IS 5887 (Part 5): 1976 Staphylococcus aureus IS 5887(Part 2): 1976; IS 5887 (Part 8/Sec I & II): 2002/ ISO 6888: 1999 APHA Chapter 39-39.5 FDA BAM Chapter 12 <10 CFU/ ml/g <100 CFU/ ml/g Detection in 1g /1 ml, /25g or 25 ml
Last Amended on - Page 7 of 14 Milk & Dairy Faecal Streptococci IS 5887 (Part 2): 1976 <100CFU/g/ ml Detection in 1g/1 ml, MPN/ ml, or g Lactic Acid Bacteria Standard Methods for examination of Dairy <1CFU/ ml <10 CFU/g/ ml Listeria Spp IS 14988 (Part 1 & 2): 2001 FDA BAM Chapter 10 5. Animal & Poultry Feed Bacterial Count (Total Plate Count) IS 5402: 2012/ ISO 4833 (Part 1): 2013, < 10 CFU/g Coliforms IS 5401 (Part 1): 2002/ ISO 4832: 1991, IS 5401 (Part 2): 2012/ ISO 4831: 2006 <0.30-110 MPN/g/ ml < 10 CFU/g Yeasts & Molds IS 5403: 1999 <1CFU/ ml <10CFU/g/ ml Escherichia coli IS 5887 (Part 1): 1976, FDA-BAM Chapter 4 <10 CFU/g / ml or <100 CFU/g/ ml, <0.30-110-110MPN/g or ml Detection/1 ml or g Faecal streptococci (Enterococci) IS 5887 (Part 2): 1976 <100CFU/g/ ml Detection in 1g/1 ml, MPN/ ml, or g Staphylococcus aureus IS 5887 (Part 2): 1976; IS 5887 (Part 8/Sec I & II): 2002/ ISO 6888: 1999, FDA-BAM, Chapter 12 <10 CFU/ g/ ml <100CFU/ ml or g Detection in 1g/ 1 ml, /25g or 25 ml
Last Amended on - Page 8 of 14 Animal & Poultry Feed Salmonella IS 5887 (Part 3): 1999/ ISO 6579: 2002 BAM-Chapter 5, APHA (4 th Edition) Chapter 37-37.123,124,1251,26 Shigella IS 5887 (Part 7): 1999, BAM-Chapter 6, APHA Chapter 38-38.23,24,25 Clostridium perfringens IS 5887 (Part 4): 1999 APHA (4 th Edition) Chapter 33-33.6 & 34-34.6 BAM-Chaper16 & 17 Bacillus cereus IS 5887 (Part 6): 2012/ ISO 7932: 2004 FDA-BAM,Chapter 14 10g/ ml or 250 g/ ml Detection/1 g or 1 ml,20 ml or 20g,25g or 25 ml <10 CFU/g/ ml or <100 CFU/g/ ml, Vibrio cholerae IS 5887 (Part 5): 1976 Vibrio parahaemolyticus IS 5887(Part 5): 1976 Vibrio vulnificus FDA BAM-Chapter 9 Listeria species IS 14988 (Part 1 & 2): 2001 FDA BAM Chapter10, APHA(4 th Edition) Chapter 36-36.5 Detection/1g, 25g. 6. Meat and Meat Bacterial Count (Total Plate Count) IS 5402: 2012/ ISO 4833: 2003 < 10 CFU/g/ ml
Last Amended on - Page 9 of 14 Meat and Meat Coliforms/ Enterobacteriaceae IS 5401 (Part 1): 2002/ ISO 4832: 1991, IS 5401 (Part 2): 2012/ ISO 4831: 2006 FDA-BAM Chapter 4 APHA (4 th Edition) Chapter 8-8-6, 8-7 / IS/ISO 7402: 1993 <0.30-110 MPN/g/ ml <1CFU/ ml < 10 CFU/g <10CFU/ ml Escherichia coli IS 5887 (Part 1): 1976, FDA-BAM Chapter 4, APHA (4 th Edition) Chapter 8-8.8,8.91,8.92 <10 CFU/g / ml or <100 CFU/g/ ml, <0.30-011 MPN/ g / ml, Detection/1 ml or g Staphylococcus aureus IS 5887 (Part 2): 1976; IS 5887 (Part 8/Sec I & II): 2002/ ISO 6888: 1999, FDA-BAM chapter 12, APHA (4 th Edition) Chapter 39-39.5 Clostridium perfringens IS 5887 (Part 4): 1999 APHA (4 th Edition) Chapter 3-33.6 & 34-34.6 BAM-Chaper16 & 17 Yeasts & Molds IS 5403: 1999 FDA-BAM, Chapter18 Salmonella IS 5887 (Part 3): 1999/ ISO 6579:2002; FDA-BAM Chapter 5, APHA (4 th Edition) Chapter 37-37.123,124,125,126 <10 CFU/ g/ ml or <100 CFU/ g/ ml Detection in 1g /25g /1 ml Detection/1 g or 1 ml,20 ml or 20g,25g or 25 ml <1CFU/ ml <10CFU/ ml/g Detection/25 ml or 10g or 25 or 250 g
Last Amended on - Page 10 of 14 Meat and Meat Listeria species IS 14988 (Part 1 & 2): 2001 FDA BAM Chapter 10, APHA (4 th Edition) Chapter 36-36.5 1g, 25g. Test For Commercial Sterility APHA (4 th Edition) Chapter 61-61.51 (Pass/Fail) 7. Snacks and Instant Mixes Bacterial Count (Total Plate Count) IS 5402: 2012/ ISO 4833: 2003, FDA-BAM Chapter 3, APHA (4 th Edition) Chapter 7-7.6 <1CFU/ ml < 10 CFU/g/ ml Coliforms IS 5401 (Part 1): 2002/ ISO 4832: 1991; IS 5401 (Part 2): 2012/ ISO 4831: 2006; FDA-BAM Chapter 4, APHA (4 th Edition) Chapter 8-8.7 Yeasts & Molds IS 5403: 1999, APHA Chapter 20-20.51,20.52, FDA-BAM Chapter18; DGHS manual Escherichia coli IS 5887 (Part 1): 1976, FDA-BAM Chapter 4, APHA (4 th Edition) Chapter 8-8.8,8.91,8.92 Bacillus cereus IS 5887 (Part 6): 2012; ISO 7932: 2004; FDA-BAM Chapter 14 <0.30-011 MPN/ g <1CFU/ ml <10CFU/ ml/g <1CFU/ ml <10CFU/ ml/g Detection/g/ ml <10 CFU/g / ml or <100 CFU/g/ ml, <0.30-011 MPN/ g / ml Detection/1 ml or g <10 CFU/g/ ml or <100 CFU/g/ ml,
Last Amended on - Page 11 of 14 Snacks and Instant Mixes Faecal streptococci (Enterococci) IS 5887(Part 2): 1976, APHA Chapter 9-9.5 <100 CFU/g/ ml Detection in 1g/1 ml, MPN/ ml or g Staphylococcus aureus IS 5887 (Part 2): 1976; IS 5887 (Part 8/Sec I & II): 2002/ ISO 6888: 1999, FDA-BAM Chapter12, APHA Chapter 39-39.5 Salmonella IS 5887 (Part 3): 1999/ ISO 6579: 2002; FDA-BAM Chapter 5, APHA (4 th Edition) Chapter 37-37.123,124,125,126 Shigella IS 5887 (Part 7): 1999; FDA-BAM Chapter 6, APHA (4 th Edition) Chapter 38-38.23,24,25 Clostridium perfringens IS 5887 (Part 4): 1999 APHA (4 th Edition) Chapter 33 & 34, FDA-BAM-Chaper16 & 17 Vibrio cholerae IS 5887 (Part 5): 1976 APHA (4 th Edition) Chapter 40-40.5, FDA-BAM Chapter 9 Vibrio parahaemolyticus IS 5887 (Part 5): 1976 FDA-BAM Chapter 9 <10 CFU/ g/ ml or <100 CFU/ g/ ml Detection in 1g /25g /1 ml Detection/25 ml 10g or 25 or 250 g <10 CFUg/ ml or <100 CFU g / ml Detection-25g,/ ml
Last Amended on - Page 12 of 14 Snacks and Instant Mixes Listeria Species IS 14988 (Part 1 & 2): 2001 FDA BAM Chapter 10, APHA (4 th Edition) Chapter 36-36.5, 1g, 25g. IV. WATER Test For Commercial Sterility 1. Drinking Water Bacterial Count or Standard Plate Count/ Heterotropic plate count APHA (4 th Edition) Chapter 61-61.51 IS 5402: 2012/ ISO 4833-1: 2013; IS 1622: 1981; IS 4251: 1967 (Pass/ Fail) <1 CFU/ ml or 100 ml, 250 ml or 1 l Coliforms IS 1622: 1981; IS 5401: 2002/ ISO 4831: 1991 Escherichia coli IS 1622: 1981 ISO 9308-2: 1990 IS 15185: 2002 <2 to >1800 MPN/100 ml, < 1CFU/ ml <2 to > 1800 MPN/100 ml), (Present/Absent) /250 ml 2. Packaged Drinking Water and Water for Process Food Industry Bacterial Count or Standard Plate Count/ Heterotropic Plate Count IS 5402: 2012/ ISO 4833-1: 2013; IS 1622: 1981; IS 4251: 1967 <1 CFU/ ml or 100 ml, 250 ml or 1 L Coliforms IS 1622: 1981; IS 5401: 2002/ ISO 4831: 1991 <2 to >1800 MPN/100 ml), < 1CFU/ ml
Last Amended on - Page 13 of 14 Packaged Drinking Water and Water for Process Food Industry Thermotolerant coliforms/faecal coliforms IS 1622: 1981 (MF/MPN), IS 15185: 2002 (MF)/ ISO 9308-2(MF)& ISO 9308-1 (MPN) <2 to >1800 MPN/100 ml), Detection/count / 250 ml Detection or count / 100 ml Escherichia coli IS 1622: 1981 ISO 9308-2: 1990 IS 15185: 2002 Enterococci IS 1622: 1981 IS 5887 (Part 2): 1976; IS 15186: 2002/ ISO 7899-2: 2000 <2 to > 1800 MPN/100 ml), Present/Absent /250 ml (MPN/100 ml) Detection or count / 250 ml Yeasts & Molds IS 5403: 1999 Detection or count/100 ml or 250 ml Pseudomonas aeruginosa IS 13428: 2005; Detection/100 ml or 250 ml, <1.8 to >1600 MPN/100 ml Staphylococcus aureus IS 5887(Part 2): 1976; IS 5887 (Part 8/Sec I & II): 2002 <1 CFU/ ml Detection/100 ml or 250 ml Salmonella IS 5887 (Part 3): 1999/ ISO 6579: 2002 & IS 15187: 2002/ ISO 6340: 1995, Detection/250 ml Shigella IS 5887 (Part 7): 1999 Detection/250 ml
Last Amended on - Page 14 of 14 Packaged Drinking Water and Water for Process Food Industry Sulphite reducing anaerobes (Clostridia) Vibrio cholera & Vibrio parahaemolyticus IS 13428: 2005 Annexure C IS 5887 (Part 5): 1976 Detection/50 ml or 100 ml Detection/250 ml Microcystine LR Envirologic kit Method 0.16 ppb to 2.5 ppb V. BIOLOGICAL TESTS ON OTHER MISCELLANEOUS TEST ITEMS 1. Sewage, Effluents And Waste Water Coliforms Enterococci IS 1622: 1981 <2 to > 1600 (MPN/100 ml or g) Faecal coliforms EPA Method 1681: 2006 < 0.18 / g or ml (MPN) Salmonella EPA Method 1682: 2005 < 0.006 / g or ml (MPN) 2. Paper Total count of bacteria ISO 8784 (Part 1): 2005 1 CFU/g Yeast and mold count ISO 8784 (part 1) : 2005 1 CFU/g 3. Genomic DNA Bacterial Identification In house Method: SOP No.30/40,2014.02.04 Issue no. 3.0 4. Genomic DNA Fungal Identification In house Method: SOP No.30/76,2014.02.04 Issue no. 1.0 -X-X-X-X-X-X-X-X-X-X-X-X-X-X-