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 Obtains Appointment from the Ministry of Agriculture, Providing the Needs for Quality, Efficacy, and Safety Tests in Pesticides
Utilization of testing technology and leading the way in the development of research on toxicity studies, SIG based on the Decree of the Minister of Agriculture of the Republic of Indonesia No. 282 of 2023 Successfully completing its appointment as a testing...
SIG Partners with Triskelion: Opening Opportunities for Small Industry to Enter the European Market
SIG is an ISO 17025 accredited quality and product safety testing laboratory that has more than a decade of experience in the world of research. In line with the spirit of being a supporting agent for actualizing a safer world #towardsasaferworld and playing an active...
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...
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