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Sterility Test

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

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.

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Bogor Laboratory & Main Office

Graha SIG:
Jl. Rasamala No. 20, Taman Yasmin, Bogor, Jawa Barat 16113.

Phone. +62(251) 7532348
Whatsapp. +62(821)11 516 516
Email. marketing-sig@saraswanti.com

Surabaya Laboratory

AMG Tower, 12th Floor, Jl. Dukuh Menanggal 1-A, Gayungan, Surabaya, Jawa Timur, 60234.

Phone: +6231 8253 1288

Jakarta Marketing Office

Ruko No.52B, Jl. Percetakan Negara, Rawasari, Cempaka Putih, Jakarta Pusat 10570.

Phone. +62(21) 21479292

Semarang Representative

Contact Person : Fajar Ery
Mobile : +62(0813) 91706805

Yogyakarta Representative

Contact Person : Zaimul Arifin
Mobile : +62(896) 48569422

Operational Hours

Monday to Friday
08.00 - 17.00 WIB.

 

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