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
SIG Addresses Industrial Water Safety Challenges through ISO-Standardized Microbial Testing at the NgoMik! #17 Collaborative Webinar
Bogor, September 3, 2026 – Bogor, September 3, 2026. As part of its efforts to introduce the latest methods for microbiological water testing to laboratory practitioners in Indonesia, SIG joined Prolabios Mitra Analitika and the Center for Public Health Laboratory (BB...
SIG Holds Audience with BPDP, Pushes for Synergy to Strengthen Competitiveness of Indonesia’s Palm Oil Industry
Jakarta, September 2, 2026 - SIG held an audience with the Plantation Fund Management Agency (Badan Pengelola Dana Perkebunan/BPDP). The meeting served as a momentum for SIG to introduce its laboratory capabilities in supporting the strengthening of the plantation...
Reading Life Through DNA
Discover Environmental Biodiversity Through eDNA SIG now offers Environmental DNA (eDNA) Analysis powered by genomics technology to help identify biological traces present in the environment. “What lives in this environment? Now, SIG can read it through DNA.” Body...
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