A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Page 2 of 4

Quality

Sterility Testing For Medical Devices

- Dr. Nishodh Saxena, Scientist, B.V. Patel Pharamceutical Education Research Centre (PERD), Ahmedabad, Gujarat, India.

Soyabean-casein digest medium:

 

Ingredients 
 Quantity
Pancreatic digest of casein 17.00 g
Papaic digest of soyabean meal 3.00 g  
Sodium Chloride 5.00 g
Dibasic potassium phosphate (K2HPO4) 2.50 g  
Dextrose (C6H12O6.H2O) 2.50 g  
Distilled water to 1000 ml
  • Sterilize in an autoclave at 121°C for 20 minutes. Cool promptly to 25°C and store at 20-30°C, avoiding excess of light. Medium can be used within 3 weeks only.

  • Use Soyabean-casein digest medium by incubating it at 20-25°C under aerobic conditions. 

Media for Penicillin or Cephalosporins:

Where sterility test media are to be used in the direct transfer method, modify the preparation of both the media by transferring aseptically a quantity of b-lactamase required to inactivate the antibiotic by using a  b-lactamase preparation that has been assayed previously for its penicillin- or cephalosporin-inactivating power.

Suitability tests for culture media:

1. Sterility of media:

Confirm the sterility of each sterilized batch of medium by incubating a portion of the batch at the specified incubation temperature for not less than 14 days or by incubating uninoculated containers as negative controls during sterility test.

2. Growth promotion test:

Separately inoculate, in duplicate, containers of each medium with less than 100 viable microorganisms of each of the strains listed below and incubate according to the conditions specified below. The test media are satisfactory if visual evidence of growth appears in all inoculated media containers within 5 days of incubation.

Guidelines for the selection of microorganisms, their growth conditions for the testing the growth promotion test and test for bacteriostasis and fungistasis as per IP.

Medium

Micro

organism

strain

incubation (7 days)

Teperature Condition

Fluid thioglycollate

Bacillus subtilis

Candida albicans

Bacteroides vulgatus

ATCC 6633

ATCC 10231

ATCC 8482

30 to 35°C

30 to 35°C

30 to 35°C

aerobic

aerobic

aerobic

Alternative thioglycollate

Bacteroides vulgatus

ATCC 8482

30 to 35°C

anaerobic

Soybean casein digest

Bacillus subtilis

Candida albicans

ATCC 6633

ATCC 10231

20 to 25°C

20 to 25°C

aerobic

aerobic

 

Guidelines for the selection of microorganisms, their growth conditions for the testing the growth promotion test and test for bacteriostasis and fungistasis as per  USP

Medium

Micro

organism

strain

incubation (7 days)

Teperature Condition

Fluid thioglycollate

Staphylococcus aureus

Pseudomonas aeruginosa

Clostridium sporogenes

ATCC 6538

ATCC 9027

ATCC 11437

32.5±2.5°C

32.5±2.5°C

32.5±2.5°C

aerobic

aerobic

aerobic

Alternative thioglycollate

Clostridium sporogenes

ATCC 11437

32.5±2.5°C

anaerobic

Soybean casein digest

 

Bacillus subtilis

Candida albicans

Aspergillus niger

 

ATCC 6633

ATCC 10231

ATCC 16404

22.5±2.5°C

22.5±2.5°C

22.5±2.5°C

 

aerobic

aerobic

aerobic

Cultures are available from

American Type Culture Collection,

10801 University Blvd. Manassas,

VA 20110-2209.

| Page 1 | Page 2 | Page 3 | Page 4 | Back | Back To Top