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
Audience with the Head of BPOM RI, SIG Ready to Support the Improvement of Product Safety & Quality in the Market
Jakarta, February 14, 2025 – SIG successfully held an audience with the Head of the Indonesian Food and Drug Authority (BPOM RI) to strengthen cooperation in monitoring the quality and safety of products, particularly in the food, cosmetics, and pharmaceutical...
Greater Jakarta Agricultural Quarantine Center for Animals, Fish, and Plants Supported by SIG in Ensuring Food Protection and Security by Showcasing Laboratory Capabilities and Capacity
Bogor, February 14, 2025 – SIG proudly welcomed a visit from the Greater Jakarta Agricultural Quarantine Center for Animals, Fish, and Plants (BBKHIT DKI Jakarta). The purpose of this visit was to present SIG’s capabilities and competencies as an SNI ISO...
Healthy Lifestyle and a Proportional Body: Understanding Foods, Supplements, and Substances That Can Be Tested in the Laboratory
A healthy lifestyle and a well-proportioned body are becoming increasingly popular in modern society. Awareness of the importance of a balanced diet, exercise, and the consumption of supportive supplements is on the rise. But do all the foods and supplements we...
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@siglaboratory.co.id
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Email. salesmedan.sig@saraswanti.com
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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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