Sterility Test

– Bioburden

– Sterility Test

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

Sterility Test Metode Analsisi

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

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.

en_USEN
Klik untuk chat
Hubungi kami via whatsapp, tim customer support SIG akan dengan senang hati membantu anda!