Sterility Test
– Bioburden
The sterility test is conducted to determine whether or not there are microorganisms in a sterilized preparation.
The principle of the sterility test is to inoculate the test portion directly or through membrane filtration and grow it into the appropriate medium (TSA and FTM). The procedure is carried out in the aseptic and maintained environment (cleanroom).. The method is according to USP 42 NF 37 <71> and ISO 11737-2:2019.
How SIG can help
SIG is offering the convenience of performing sterility testing. SIG has cutting-edge technologies to support sterility testing.
Medical devices/health care products::
- sterile cotton
- sterile gauze
- Sterile surgical suture
- Syringe
- Needle
- Sterile Catheters
- Blood bag
- Blood transfusion set
- Infusion set
- Surgical gloves
- Urine bag
- Implants
- Surgical drapes (plastic)
- Surgical paper
- Gowns
Method of analysis
The sterility test 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
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)...
AOAC 2017 & 2022 Dietary Fiber, Appropriate Methods for Accurate Results
Fiber is a type of carbohydrate that cannot be digested by the human body so it can help regulate the body's use of sugar, helping to keep hunger and blood sugar in check. Great sources are whole grains, whole fruits and vegetables, legumes, and nuts (Institute of...
Leading for rice safety test! SIG become the one and only lab in South East Asia for Sulfuryl Fluoride detection
Rice is one of the main food commodities that are consumed by many people, especially in fulfilling carbohydrate intake. Central Bureau Statistics of Indonesia records rice consumption in Indonesia reaching 32.07 million tons in 2022. To protect the quality of rice...
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 Jakarta
Jl. Percetakan Negara No. 52 B RT 006 / RW 001, Rawasari, Cempaka Putih, Jakarta Pusat 10570.
Phone. +62 21 2147 9292
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
SIG Semarang
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.
FOLLOW US