Sterility Test
– Bioburden
The sterility test is conducted to determine whether or not there are microorganisms in a sterilized preparation.
The principle of the sterility test is to inoculate the test portion directly or through membrane filtration and grow it into the appropriate medium (TSA and FTM). The procedure is carried out in the aseptic and maintained environment (cleanroom).. The method is according to USP 42 NF 37 <71> and ISO 11737-2:2019.
How SIG can help
SIG is offering the convenience of performing sterility testing. SIG has cutting-edge technologies to support sterility testing.
Medical devices/health care products::
- sterile cotton
- sterile gauze
- Sterile surgical suture
- Syringe
- Needle
- Sterile Catheters
- Blood bag
- Blood transfusion set
- Infusion set
- Surgical gloves
- Urine bag
- Implants
- Surgical drapes (plastic)
- Surgical paper
- Gowns
Method of analysis
The sterility test is carried out using a Clean Room, including classes D, C, B, and A. Class B (room) and A (BSC) are the places for testing.
Library of Knowledge
Proof of Synergy: Ministry of Health Visits SIG, Drives Strengthening of Testing and Quality Assurance for Medical Devices
Bogor, August 11 2026 – SIG once again welcomed a visit from the Directorate of Medical Device Surveillance, Ministry of Health of the Republic of Indonesia, as part of the Quality Assurance Development Program for medical devices circulating in Indonesia. The visit,...
Strengthening Bioscience Research Capabilities, SIG Showcases Laboratory Expertise During Korea International Cooperation Agency (KOICA) Delegation Visit as Part of the 2026 NICAB Workshop
Bogor, July 24 2026 - SIG welcomed delegations from the Korea International Cooperation Agency (KOICA) as part of the field excursion program of the NICAB Workshop 2026, held under the theme "Enhancing Cutting-Edge Bioscience Research through Advanced Scientific...
SIG Presents Molecular Detection Technology for Halal Authentication at the 2026 NICAB Workshop
Bogor, July 22 2026 – SIG participated as a speaker at the 2026 NICAB Workshop during Session 3: Advanced Halal Science and Innovation, held on Wednesday, July 22 2026 at the IPB International Convention Center (IICC), Bogor. Carrying the theme "Enhancing Cutting-Edge...
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