SOP for Sterility Testing for Medical Device

PURPOSE

This SOP provides guidelines for the Sterility Testing of products subjected to sterilization.

SCOPE

The sterility tests is intended for detecting the presence of viable forms of microorganisms in the reported sterilized products.

The tests must be carried out under conditions designed to avoid accidental contamination of the product during the test.

RESPONSIBILITIES

QC, a Microbiologist is responsible for executing the process.

QA oversees that the operating procedure has been followed.

MEDIA FOR TESTING

• Fluid Thioglycollate Medium (FTM)
• Soybean Casein Digest Medium(SCDM)

QUANTITY OF SAMPLE TO BE TESTED

• 20 Pieces sampled from 100 pieces per batch.

MATERIAL APPARATUS

• Sterile forceps
• Sterile scissors
• Sterile test tubes (or flasks)
• Sterile gloves
• Sterile mask
• 70% IPA
• Clean bench
• Biological indicator-sterile and unsterile

PRELIMINARY REQUIREMENT

• The microbiologist staff must sanitize the sterility testing room in accordance with cleaning procedures to assure its cleanness monthly.
• Wash hands by using soap and disinfectant, respectively.
• Switch ”ON the UV Lamp in Bio Safety Cabinet and expose it for a minimum of 17 minutes.
• Transfer the test samples through Passbox, sanitize using 70%IPA and place it in the Bio Safety cabinet.
• Turn off the UV lamp and warm up for 3 minutes, before testing.
• Dress the sterility testing uniform including sterile gloves and mask as well, then enter into the sterility testing room.
• Disinfect the outside of the product package by spraying it with 70% IPA and placing it on a clean bench.
• Incinerate the media tube/flask mouth while opening and closing.

TEST PROCEDURE

PRODUCT	PROCEDURE
Syringe	Open the individual package under the Bio Safety Cabinet and separate parts of the syringe into a barrel, plunger, gasket, and needle by using pre-sterilized forceps, then immerse them into the culture media without external contamination.
Infusion Set	Open the individual package under the Bio Safety Cabinet and then take out the Infusion set using pre-sterilized forceps, and using forceps remove the protector from the needle and transfer the protector into the culture media test tube. Separate the wing from the set by cutting with a pre-sterilized scissor and transfer it into a culture media tube. Finally cut the tube of the set into small pieces with scissors and transfer into the culture media tube.
Blood tubing set	Open the individual package aseptically under Bio Safety Cabinet, choose the portion of the bloodline that is difficult to sterilize, cut these portions and immerse them into the culture medium.
Catheter	Open the individual package under the Bio Safety Cabinet and separate parts of the catheter by using pre-sterilized forceps and scissors, and immerse them into the culture medium.
Specimen collection swabs (oral/nasal)	Open the individual package under Bio Safety Cabinet using pre-sterilized forceps, then immerse the swab into the culture media without external contamination.

ALSO READ: SOP for Preparation and Sterilization of Microbial Media

INCUBATION

After proper marking for identification, all the FTM and SCDM test tubes run the test sample together with biological indicators. One for the positive control which contains an unsterilized biological indicator (Bacillus spp.) andthe  negative control containing a sterilized biological indicator incubated at 30°C-35°C and 20°C-25°C respectively for not less than 14 days.

Sr. No.	Name of Media	Microbial Culture	Incubation Temperature
1.	FTM	(Aerobic bacteria) S.aureus ATCC 6538 B.subtilis ATCC6633 P.aeruginosa ATCC 9027	30°C-35°C
2.	SCDM	B.subtilis ATCC 6633 C.albicans ATCC 10231 A.niger ATCC 16404	30°C-35°C 20°C-25°C 20°C -25°C

OBSERVATION AND INTERPRETATION OF THE RESULTS

Observe the incubated tubes daily for microscopic evidence of microbial growth. Record the observation, the specimen complies with test results if :

• No sign of growth is observed in the specimen tube till the 14th day.
• No sign of growth is observed in the negative control.
• No sign of growth is observed in test media negative control.
• Growth is observed in bacterial positive control within 3 days.
• Growth is observed in fungal positive control within 5 days.
• The media used should have passed the growth promotion test.

The test may be considered invalid only if one or more of the conditions are fulfilled.

• The data of microbiological monitoring of the sterility testing facility shows a fault.
• Microbial growth is found in negative controls.

Note:

If the test is declared to be invalid it is repeated with the same number of units as in the original test. If no evidence of microbial growth is found in the repeat test, the product examined should comply with the test for sterility and if growth is found, the product does not comply with the test for sterility.

REFERENCE

The United States Pharmacopeia (current revision).

The Pharmacopeia of Japan (current revision)

ABBREVIATIONS

SOP: standard operating procedure

QA: Quality Assurance

QC: Quality Control

UV: Ultra Violet

IPA: Isopropyl Alcohol

SPP: Species

FTM: Fluid Thioglycollate Medium

SCDM: Soybean Casein Digest Medium

ANNEXURE

Nil

REVISION HISTORY

Nil

ALSO READ: Sterility Test Validation Protocol