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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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
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Jl. Percetakan Negara No. 52 B RT 006 / RW 001, Rawasari, Cempaka Putih, Jakarta Pusat 10570.
Phone. +62 21 2147 9292
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Phone. +62 31 8253 1288
WhatsApp. +62 818 885 165
Email. marketing@sigsurabaya.com
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Jl. Kanfer Raya Blok R No. 4 Pedalangan, Kec. Banyumanik, Kota Semarang, Jawa Tengah 50268.
Phone. +62 24 7004 0541
WhatsApp. +62 812 9000 5165
Email. cs.sigsmg@saraswanti.com
SIG Medan
Jl. Bunga Asoka, Ruko Komp. Asoka Raya Residance No. 1, Medan Selayang, Sumatera Utara 20133,
WhatsApp. +62 822 7207 9665
Email. salesmedan.sig@saraswanti.com
SIG Yogyakarta
WhatsApp. +62 896 4856 9422
Email. arifin.sig@saraswanti.com
SIG Makassar
WhatsApp. +62 853 3843 9816
Email. anwar@sigsurabaya.com
Operational Hours
Monday to Friday
08.00 - 17.00 WIB.
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