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
Fulfill BSN KAN Invitation: SIG Ready to Collaborate to Enhance Laboratory Role Education in the Community
Jakarta, March 27, 2025 – On this occasion, SIG responded to the invitation from BSN KAN to have a direct audience with Dr. Agustinus Praba Drijarkara, Director of Laboratory Accreditation, and his team. SIG was represented by Mr. Adi Mulyadi, QA Manager, and Mr....
Explained the Capabilities and Capacity of the Lab, SIG Ready to Support the Needs of the Indonesian Quarantine Agency
Jakarta, March 20, 2025 – It is an honor for SIG to be directly received by Mr. Shahandra Hanitiyo, S.IP, M.Si., Secretary of the Indonesian Quarantine Agency, and his team. The visit, led by the President Director of SIG, Dr. M. Edi Premono, aimed to present and...
SIG Receives “Good” Rating in the BPOM External Laboratory Recognition Pilot Project
Bogor, March 19, 2025 – It is an honor for SIG to accept the invitation from the Head of BPOM, Prof. Taruna Ikrar M.Biomed PhD, for the presentation of the certificate of the BPOM External Laboratory Recognition Pilot Project for testing laboratories. SIG successfully...
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Phone. +62 24 7004 0541
WhatsApp. +62 812 9000 5165
Email. cs.sigsmg@saraswanti.com
SIG Yogyakarta
WhatsApp. +62 896 4856 9422
Email. arifin.sig@saraswanti.com
Operational Hours
Monday to Friday
08.00 - 17.00 WIB.
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