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 & Resistomap in Action – Workshop Antimicrobial Resistance (AMR)
In line with our commitment to creating a safer world, SIG and Resistomap May 31st, 2023, successfully held training on monitoring antimicrobial resistance (AMR) in water samples.The workshop was guided directly by Mr. Jesse Majlander,the Operations Manager of...
Verification Visit by the Indonesian Agency of Fish Quarantine, Quality Control, and Safety of Fishery Products (BKIPM) at SIG
SIG as a laboratory that conducts fishery products testing received a visit from the Indonesian Agency of Fish Quarantine, Quality Control, and Safety of Fishery Products (BKIPM) on May 31st, 2023, at SIG Central Lab located at Jl. Rasamala No. 20 Bogor City.This...
SIG successfully explained the importance of Sulfuryl Fluoride (SF) analysis at the Asia Pacific Food Analysis Forum (APFAN) 2023
On Wednesday 24 May 2023, SIG through its representative, Insan Patria as the supervisor of the research division, had the opportunity to present about the importance of conducting Sulfuryl Fluoride (SF) tests on rice in the Asia Pacific Food Analysis Forum (APFAN)...
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