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Sterility Testing Consumables, Media & Instruments

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  • Sterility testing equipment for microbiological quality control
  • Membrane Filtration Steritest Testing
  • Sterility Testing Culture Media & Rinsing Fluids
  • Sterility Testing Peristaltic Pump
  • Sterility Testing Services & Maintenanc
  • Rapid sterility testing method using fluorescence-based detection with Milliflex® Rapid system 2.0
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Sterility testing is an essential part of validation for products manufactured according to GMP purporting to be sterile. False negative results could lead to the release of contaminated products, whereas false positives could give rise to lengthy and costly investigations. Have confidence in your sterility test results with our extensive portfolio of Quality control solutions that you can rely on for regulatory compliance e.g. with USP, the European Pharmacopoeia and the Japanese Pharmacopoeia. 

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Products

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Product Number
Product Description
Pricing
STBMTSB12
Soybean Casein Digest Broth (TSB), ready-to-use, bottle volume 100 mL , filling volume
STBMCTM12
Clear Fluid Thioglycollate Medium, ready-to-use, bottle volume 100 mL , filling Volume
1.46628
Sterile Isopropyl Myristate (IPM), ready-to-use, bottle volume 360 mL , filling volume
STBMRFA12DP
Fluid A, Double packed, double packed of, ready-to-use, bottle volume 100 mL , filling volume
22089
Casein peptone Lecithin Polysorbate Broth, suitable for microbiology, NutriSelect® Plus
1.46139
Thioglycollate Medium, ready-to-use, tube volume 10 mL , filling volume
1.46220
Thioglycollate Medium, tube of, ready-to-use, tube volume 9 mL , filling volume
90404
Thioglycolate Broth with Resazurine, suitable for microbiology, NutriSelect® Plus
T9032
Thioglycollate medium, Microbiologically tested, NutriSelect® Plus
70157
Thioglycollate Broth (USP Alternative), suitable for microbiology, NutriSelect® Plus
1.46469
Fluid D acc. USP, ready-to-use, bottle volume 500 mL , filling volume
STBMCTM12DP
Clear Fluid Thioglycollate Medium, double packed of, ready-to-use, bottle volume 100 mL , filling Volume
1.46492
Tryptic Soy Broth with TLHC (Inactivator B.), ready-to-use, bottle volume 90 mL , filling volume
41298
Tryptic Soy Broth, Vegitone, suitable for microbiology, NutriSelect® Plus
1.46053
RSTM Cassette, For sterility testing with Milliflex® Rapid System
SYMBDTH01
Steritest® Symbio complete drain tray, For 2 canisters, LFH pump
1.46715
Fluid Thioglycollate Medium + 0.5% Tween® 80, bottle of, ready-to-use, bottle volume 100 mL , filling volume
TZNFVSP20
Steritest® Sampling Needle-Free Valve, sterile; ethylene oxide treated
SYMBISL01
Steritest® Symbio ISL Pump, 2 media pump kit for use in isolator
SYMBRACK2
Steritest® racks, to hold-up to 4 Steritest®carrying trays, for use with Steritest® NEO Devices, pkg of (2 racks per pack)
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Related Product Resources

Brochure: Sterility Testing Complete Portfolio
Brochure: Steritest® NEO Devices
Poster: Complete Solutions for Complete Confidence with the Steritest® System
Datasheet: Steritest® Culture Media and Fluids 

Datasheet: Steritest® Symbio Pump and Accessories
Article: Sterility Testing of Products with Antimicrobial Properties
Article: Sterility Testing of Products to be Diluted in Isopropyl Myristate
Datasheet: Milliflex® Rapid System

Steritest® System for Sterility Testing

Configure your Steritest® system to fit your sample, packaging, and controlled testing environment needs.

Our portfolio, which offers a fully regulatory compliant testing workflow (USP <71>, EU Pharmacopoeia < 2.6.1> and JP Pharmacopoeia <4.06>) includes:

  • Sterility testing pumps and accessories
  • Membrane filtration devices
  • Culture media, rinse fluids and solvent
  • Direct inoculation method

MILLIFLEX® RAPID SYSTEM FOR RAPID STERILITY TESTING

The Milliflex® Rapid System 2.0 is an automated solution for the rapid detection, imaging, and quantification of viable microbial contaminants in filterable samples throughout the manufacturing process. Its state-of-the-art ATP-based technology and highly sensitive detection camera, allow the Milliflex® Rapid System 2.0 to deliver sterility results in 5 days instead of the traditional 14 days resulting in faster corrective actions in case of contamination.

Sterility Testing Devices

Minimizing the risk of false positive and false negative results, the Steritest® NEO unit has been proven to be the most reliable filtration device available on the market.

Sterility Testing Culture Media and Fluids

Our sterility testing culture media and rinse fluids are formulated and tested to meet international standards. They provide the highest level of quality and testing confidence.

Sterility Testing Pumps

Our Steritest® Symbio pumps are designed to integrate perfectly into all testing environments. They will speed up and streamline your workflow, maximizing safety, confidence and convenience.

Sterility Testing Accessories

The Steritest® Symbio accessories are designed to facilitate your daily sterility testing work routine. To address your special requirements, accessories are available for a variety of different drug packaging configurations.

Direct Inoculation Method

Sterility testing of non-filterable samples, complying with your different direct inoculation method requirements.

Rapid Sterility Testing Method

The Milliflex® Rapid System 2.0 has been proven to be used for rapid sterility testing by the FDA’s Center for Biologics Evaluation and Research as a faster sterility test to identify microbial contamination in biologicals.

Related Product Categories
Pyrogen Testing
Pyrogen testing is a critical step in ensuring the safety of parenteral pharmaceutical products and medical devices. The Monocyte Activation Test (MAT) is an in vitro pyrogen test that can detect both endotoxin and non-endotoxin pyrogens in one test.
Hygiene Monitoring Instruments, Samplers, Tests & Accessories
Hygiene monitoring verifies the effectiveness of your sanitization routine using methods like ATP testing, NAD testing, protein testing or swab sampling.
Viable Air Samplers
Active air samplers impact microorganisms of a known volume of air onto an agar medium for detection of colony-forming units. Our MAS-100® and RCS® air sampler series provide accurate results with good repeatability and regulatory compliance.
Microbial Filtration
Complete membrane filtration systems for accurate results in bioburden testing. Rapid microbial testing technologies can speed up your time-to-result.
Related Applications
Sterility Testing
Sterility testing is an essential process necessary for sterilization validation. Membrane filtration is a preferred method for sterility testing of pharmaceuticals, food and beverages, tissue materials and other products that claim to be sterile.
Pyrogen Testing
The pyrogen test measures the pyrogenic load in parenteral products. It is a regulatory requirement for the release of sterile parenteral drugs
Bioburden Testing
Bioburden testing measures the levels of microbial contamination in water, raw materials, and finished products.
Mycoplasma Testing in the Pharmaceutical Industry
Mycoplasma can grow to high titers in culture cultures, adversely impacting these. In the pharmaceutical industry Mycoplasma testing is key to detect contamination early and avoid loss of time and production batches.
Vaccine Manufacturing
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Monoclonal Antibody Manufacturing
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Classical Pharmaceutical Formulation & Manufacturing
Manufacturing the final dosage form of a small molecule drug requires robust quality and design in development of the formulation and production of the final product. Explore solutions and best practices to advance and accelerate small molecule pharmaceuticals, from development to commercialization.
mRNA Development & Manufacturing
Our comprehensive portfolio of products and services provides everything you need for mRNA synthesis, purification, and formulation for development and manufacturing.
Related Services
Pharma Microbiology Method Development & Validation
When a microbial test method (S.O.P.) needs to be set up for a new product or improved for a product that demonstrates antimicrobial effects and/or filtration issues, our applications laboratory can develop a method that is compliant with applicable regulations (Pharmacopoeias). As a company, we are known for the quality of our products. We apply these same high standards to our methods development assignments and keep the same strict attention to regulatory compliance.
System and Equipment Installation for Microbiology Testing Systems
Installation of your lab system is an important step before commissioning your equipment or prior to any qualification and it could be critical for system integrated in isolator.
Maintenance & Service Plans
Browse our maintenance and service plans for Milli-Q water purification systems and our microbiology testing systems.

Highlights

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  • Analytical Cannabis Testing Solutions

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    • Residual Solvents
    • Moisture Analysis
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