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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.

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)...

SIG Laboratory

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

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

SIG Surabaya

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

Phone. +62 31 8253 1288
WhatsApp. +62 818 885 165
Email. marketing@sigsurabaya.com

 

Operational Hours

Monday to Friday
08.00 - 17.00 WIB.

 

 

 

 

SIG Jakarta

Jl. Percetakan Negara No. 52 B RT 006 / RW 001, Rawasari, Cempaka Putih, Jakarta Pusat 10570.

Phone. +62 21 2147 9292                                                                                 

SIG Semarang

Jl. Bina Remaja No. 1A (Ruko A) Banyumanik, Kota Semarang, Jawa Tengah 50264.

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

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