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Sterility Test

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

Prove it Spicy by Scoville Heat Units Test!

Prove it Spicy by Scoville Heat Units Test!

CapsaicinoidsCapsaicinoids are the chemical components in capsicum that give the sensation of a spicy taste. The most common and most abundant capsaicinoid in hot peppers is capsaicin. In the food industry, capsaicin content is often used as added value in products as...

GMP+ International Certification

GMP+ International Certification

Along with SIG's determination to strengthen its existence as part of a global network and towards a safer world, we are proud to announce that SIG has successfully received its first GMP+ FSA International (Good Manufacturing Practice System, Feed Safety Assurance)...

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Phone. +62 24 7640 3685
WhatsApp. +62 812 9000 5165
Email. cs.sigsmg@saraswanti.com

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