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.
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