Sterility can be defined as the freedom from the presence of viable microorganisms. The sterility test of sterile pharmaceuticals tests to determine the presence or absence of extraneous viable contaminating microorganisms in a sterilized pharmaceutical. The test for sterility is carried out under aseptic conditions.

Sterility test is an important part of GMP microbiology. USP <71> prescribes the sterility testing method used for pharmaceuticals and biologics.

 

How SIG can help

SIG laboratory provides sterility testing for pharmaceuticals with a method referring to USP 42 NF 37, 2019 <71>.

The types of samples that can be tested are:

  • Liquid infusion
  • Injection drug
  • Liquid injection antibiotics
  • Solid injection antibiotics
  • Antibiotic cream
  • Sterile aerosol products (asthma medication)
  • Liquid medicine

 

Method of Analysis

Sterility Test Metode Analisa

The sterility test at SIG laboratory 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

Peran Penting Lab Uji Makanan, Demi Keamanan Suatu Produk

Peran Penting Lab Uji Makanan, Demi Keamanan Suatu Produk

Saat kita menikmati makanan di rumah, restoran, atau membeli produk kemasan, jarang sekali kita memikirkan tentang proses pengujian yang memastikan keamanan dan kualitasnya. Di balik layar, lab uji makanan bekerja keras untuk memastikan produk yang kita konsumsi bebas...

SIG Laboratory

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Phone. +62 251 7532 348
WhatsApp. +62 82 111 516 516
Email. marketing-sig@saraswanti.com

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Phone. +62 21 2147 9292  

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Email. marketing@sigsurabaya.com

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Phone. +62 24 7004 0541
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WhatsApp. +62 822 7207 9665
Email. salesmedan.sig@saraswanti.com

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WhatsApp. +62 896 4856 9422
Email. arifin.sig@saraswanti.com

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WhatsApp. +62 853 3843 9816
Email. anwar@sigsurabaya.com

Operational Hours

Monday to Friday
08.00 - 17.00 WIB.

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