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Media Fill Test Kits & Sterility Control for PIC/S-, USP<797>, ISO13408-1 or GMP-guidelines

Media fill testing To assess operators ability to maintain the sterility of materials during preparation of aseptically prepared injectable dose forms, bioTRADING developped the ‘Universal Operator Broth Test Kit’ based on the UK NHS-protocol. Universal Operator Broth Transfer Kit Item no. UOBTK1 kit includes: 1 x TSB Glass break ampoule 1 x TSB, 50 ml vial 1 x TSB, 100 ml infusion bag 3 x Sterile vial Description Universal Operator Broth Transfer Kit 1

* protocol NHS, UK Pharmaceutical Aseptic Services Committee (formerly UK National CIVAS Group)

Sterility Control bioTRADING offers a wide range of sterile vials, Tryptic Soy Broth (TSB) products and sterile dehydrated culture media allso known as INSTAMEDIA to mimic cytostatic compounding and media fills. Contact us for customized volumes, media, packaging,... Sterile vials Item no. K500F000QK K500F000QV TSB vials Item no. K111F050QV K111F010QK K244F010QK K260F010QK Infusion bags Item no. K111Z100TM K111Z550DX K111Z1000RE K111Z1000RH Infusion bottles Item no. K111F100CR K111F500DP K119F100CQ Description Vial 20 ml, grey septum/open felscap Vial 50 ml, grey septum/open felscap Pack Size Pack, 100 pcs. Pack, 50 pcs. Description Pack Size TSB, 50 ml, Vial 50 ml, grey septum/open felscap Pack, 50 pcs. TSB, 10 ml, Vial 20 ml, grey septum/open felscap TSB, 2x Concentrated, 10 ml, Vial 20 ml, grey septum/open felscap TSB, 4x Concentrated, 10 ml, Vial 20 ml, grey septum/open felscap Pack, 100 pcs. Pack, 100 pcs. Pack, 100 pcs. Description TSB, 100 ml Pack Size TSB, 550 ml, gamma irradiated, 1 tyvek TSB, 1000 ml TSB, 1000 ml, gamma irradiated, 1 tyvek infusion bag 100 ml infusion bag 600 ml infusion bag 1000 ml infusion bag 1000 ml Description TSB, 100 ml, infusion bottle 100 ml, blue felscap TSB, 500 ml, infusion bottle 500 ml, blue felscap FTM, 100 ml, infusion bottle 100 ml, red felscap Pack Size 1 pcs. 1 pcs. 1 pcs.

Instamedia (powder) Item no. K240I010TD K656I010TD K554I010TD Description Pack Size TSB InstaMediA, powder for 10 ml, Vial 20 ml, grey septum/open felscap, gamma irradiated TSB InstaMediA, 4x Concentrated, powder for 10 ml, Vial 20 ml, grey septum/open felscap, gamma irradiated TSB InstaMediA, 10x Concentrated, powder for 10 ml, Vial 20 ml, grey septum/open felscap, gamma irradiated Glass break ampoule Item no. Description K111F020QN TSB, 20 ml, glass break ampoule Environmental monitoring In order to check your environment for contaminating microorganisms, bioTRADING offers multiple media for air-sampling, water-sampling, surface sampling and/or finger daps of your staff. Settle plates Item no. K123P090MF (*) K909P090MF (*) Description K123P090KT TSA, Petri dish 9 cm, gamma irradiated, 1 tyvek TSA, Petri dish 9 cm, silicagel, gamma irradiated, 1 AT bag TSA + Tween + Lecithin + Histidine + Thiosulfate, Petri dish 9 cm, silicagel, gamma irradiated, 1 AT bag * Extended shelf life & room temperature storage Contact plates Item no. K029R055QJ (*) K909R055QJ (*) Pack, 10 plates Pack Size Pack, 10 plates Pack, 10 plates Pack, 100 pcs. Pack, 100 pcs. Pack, 100 pcs. Pack size Pack, 8 pcs. Description Pack Size K029R055PU TSA + Tween + Lecithin, TwistLock™ 5.5 cm, gamma irradiated, 1 tyvek TSA + Tween + Lecithin, TwistLock™ 5.5 cm, silicagel, gamma irradiated, 1 AT bag TSA + Tween + Lecithin + Histidine + Thiosulfate, TwistLock™ 5.5 cm, silicagel, gamma irradiated, 1 AT bag * Extended shelf life & room temperature storage Pack, 10 plates Pack, 10 plates Pack, 10 plates

Quality Control Strains Microbiologics is the most trusted expert in the production, preservation, and manipulation of biological materials for cultural purposes such as growth promotion- (GPT), media challenge - and micobial enumeration testing. Item no. MBL8172 Description EZ-AccuShot™ Select - Aspergillus brasiliensis derived from ATCC® 16404 - Bacillus subtilis subsp. spizizenii derived from ATCC® 6633™ - Candida albicans derived from ATCC® 10231™ - Escherichia coli derived from ATCC® 8739™ - Pseudomonas aeruginosa derived from ATCC® 9027™ - Staphylococcus aureus subsp. aureus derived from ATCC® 6538™* Instructions for use In-house isolate identification and custom controls for environmental monitoring

Pro-Racks Standard or customized racks manufactured from a high molecular weight polyethalene (HMWPE), which will withstand high temperatures for cleaning and decontamination. available in different bright colours for easy and convenient coordination in the lab. Sterilisation monitoring products Validate the effectivenes of sterilisation processes, monitor and assure adequate sterilisation of products and instruments. - Bowie-Dick Tests - Biological indicators - Self-contained Biological Indicators - Spore Ampoules & incubators - Spore strips - Mini-Spore strips & discs - Chemical indicator - Radiation - Chemical indicator - Ethylene Oxide - Chemical indicator - Dry Heat - Chemical indicator - Steam - Chemical indicator - Hydrogen Peroxide - Indicator tape & test strips

Environmental monitoring software Sherpa Pharma offers a software platform for managing environmental monitoring processes in pharmaceutical cleanrooms. www.bioTRADING.com HEAD OFFICE AND PRODUCTION FACILITY Communicatieweg 7 | 3641 SG Mijdrecht The Netherlands T +31(0)297-286848 E sales@biotrading.com SALES OFFICE BELGIUM & LUXEMBOURG Haachtsebaan 143 | 3140 Keerbergen Belgium T +32(0)15-500100 F +32(0)15-500101 E info@biotrading.be

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