[8] sterility testing

sterile products

dosage forms of therepeutic agents that are free of viable microorganism

sterile products must be

free from contaminants because they bypass the body’s usual defense against infections

influences on strerile products

product

• product and materials

• depyrogenation

• sterilization

• product and material flow

• validation

• storage conditions

• personnel practices and training

influences on strerile products

equipment

• equipment design

• area equipment

• sterilization

• qualification

• procedures

• cleaning and maintenance

• presonnel practices and training

influences on strerile products

environment

• facility design

• personnel traffic flow

• HVAC

• personnel practices and training

• cleaning and maintenance

• qualification

• personnel hygiene

• decontamination

• utility systems

• effects from adjacent areas

aseptic processing is designed to __

prevent the introduction of viable microorganisms into separately sterilized materials during their assembly into a sealed sterile package

aseptic processing

sterilized materials should be protected from contaminants starting from point of sterilization up to the closure of the primary package

terminally sterilized products

lowest risk category of sterile pharmaceutical products

terminally sterilized products

sterilization process imparts __

quantifiable safety level by delivering measurable physical condition that corresponds to microbial lethality

terminally sterilized products

probability of the terminal sterilization process genetating a __

nonsterile unit of ≤ 10^-6 or nmt one nonsterile unit in one million units produced

METHOD SUITABILITY TEST (METHOD VALIDATION) GROWTH PROMOTION TEST

Place 5 mL of Fluid Thioglycollate Medium in each of two test tubes, then inoculate the medium with 0.1 mL (90 cfu) of __ microbial suspension separately.

Pseudomonas aeruginosa and Staphylococcus aureus

METHOD SUITABILITY TEST (METHOD VALIDATION) GROWTH PROMOTION TEST

Place 5 mL of Soybean-Casein Digest Medium in each of two test tubes, then inoculate the medium with 0.1 mL (90 cfu) of ___ microbial suspension separately.

Bacillus subtilis and Candida albicans

METHOD SUITABILITY TEST (METHOD VALIDATION) GROWTH PROMOTION TEST
Incubate the Fluid Thioglycollate Medium at (temp)

30^o -35^oC

METHOD SUITABILITY TEST (METHOD VALIDATION) GROWTH PROMOTION TEST
Incubate the Fluid SCDB at (temp)

20-25 C

METHOD SUITABILITY TEST (METHOD VALIDATION) GROWTH PROMOTION TEST
bacteria are incubated for __ days

3

METHOD SUITABILITY TEST (METHOD VALIDATION) GROWTH PROMOTION TEST
fungi are incubated for __ days

5

METHOD SUITABILITY TEST (METHOD VALIDATION) GROWTH PROMOTION TEST
Acceptance Criteria

Clear visible growth of the microorganisms (turbidity) is present in the culture media

METHOD SUITABILITY TEST (METHOD VALIDATION) GROWTH PROMOTION TEST
Interpretation

used to demonstrate if Fluid Thioglycollate Medium and Sodium-Casein Digest Medium are suitable for the detection of the test microorganisms.

METHOD SUITABILITY TEST (METHOD VALIDATION) SUITABILITY OF TEST METHOD (Bacteriostasis and Fungistasis)

CONTROL

Place 10 mL of Fluid Thioglycollate Medium in each of two test tubes, then inoculate the medium with 0.1 mL (90 cfu) of Pseudomonas aeruginosa and Staphylococcus aureus microbial suspension separately.

METHOD SUITABILITY TEST (METHOD VALIDATION) SUITABILITY OF TEST METHOD (Bacteriostasis and Fungistasis)

CONTROL

Place 10 mL of Soybean-Casein Digest Medium in each of two test tubes, then inoculate the medium with 0.1 mL (90 cfu) of Bacillus subtilis and Candida albicans microbial suspension separately.

METHOD SUITABILITY TEST (METHOD VALIDATION) SUITABILITY OF TEST METHOD (Bacteriostasis and Fungistasis)

CONTROL

Incubate the Fluid Thioglycollate Medium at 30 -35C, and the SoybeanCasein Digest Medium at 20 -25C for 14 days.

METHOD SUITABILITY TEST (METHOD VALIDATION) SUITABILITY OF TEST METHOD (Bacteriostasis and Fungistasis)

TEST PRODUCT

Place 10 mL of Fluid Thioglycollate Medium in each of two test tubes and add 1 mL of normal saline solution. Inoculate the medium with 0.1 mL (90 cfu) of Pseudomonas aeruginosa and Staphylococcus aureus microbial suspension separately.

METHOD SUITABILITY TEST (METHOD VALIDATION) SUITABILITY OF TEST METHOD (Bacteriostasis and Fungistasis)

TEST PRODUCT

Place 10 mL of Soybean-Casein Digest Medium in each of two test tubes and add 1 mL of normal saline solution. Inoculate the medium with 0.1 mL (90 cfu) of Bacillus subtilis and Candida albicans microbial suspension separately.

METHOD SUITABILITY TEST (METHOD VALIDATION) SUITABILITY OF TEST METHOD

Acceptance Criteria

Clear visible growth of the microorganisms (turbidity) is present in the culture media.

METHOD SUITABILITY TEST (METHOD VALIDATION) SUITABILITY OF TEST METHOD
Interpretation

used to demonstrate that the test is suitable for the evaluation of a sterile product (normal saline solution).

STERILITY TESTING
PRODUCT TESTING

Place 10 mL of Fluid Thioglycollate Medium in a test tube and add 1 mL of normal saline solution.

STERILITY TESTING
PRODUCT TESTING

Place 10 mL of Soybean-Casein Digest Medium in a test tube and add 1 mL of normal saline solution

PRODUCT TESTING Acceptance Criteria

There should be no evidence of microbial growth.

PRODUCT TESTING
Interpretation

Sterility test is used to determine if the product tested is sterile.