Sterility testing consumables, media & instruments
Ensure your products meet sterility standards with advanced testing tools that seamlessly integrate into your quality control processes, offering rapid and reliable microbial detection across diverse applications.
The Steritest® NEO and Milliflex® Rapid System 2.0 from the trusted Steritest® and Milliflex® brands revolutionize sterility testing and microbial detection in pharmaceutical and biopharmaceutical production. The Steritest® NEO employs a robust filtration mechanism to streamline sterility assurance, minimizing the risk of false positives and negatives. Its pump and accessories seamlessly integrate into existing workflows, providing unmatched efficiency in testing workflows for injectable vaccines, monoclonal antibodies, and other sterile products.
Meanwhile, the Milliflex® Rapid System 2.0, with its cutting-edge ATP-based detection technology, delivers sterility results in just 5 days compared to traditional methods requiring 14 days. This rapid turnaround allows for swifter corrective actions, optimizing production times and ensuring product safety. Designed for parenteral products, these systems fit seamlessly into automated and continuous operations, offering the reliability and compliance needed in today’s stringent regulatory environment.
Available in materials suitable for high-corrosion environments, these systems meet stringent GMP, USP, and EU Pharmacopoeia standards. Both systems offer ease of maintenance and can be customized to meet specific testing requirements, with comprehensive engineering support for integration into specialized production environments.
Benefits
- Speeds up production with rapid microbial detection, reducing sterility test times from 14 to 5 days.
- Enhances reliability with advanced filtration mechanisms, minimizing false test results.
- Ensures compliance with global pharmacopoeia standards, streamlining regulatory approvals.
- Integrates seamlessly into existing production lines, reducing installation and transition costs.
- Offers flexible configuration and customization options, meeting diverse industry-specific needs.
- Applications
- Small molecule drugs,Water,Raw materials,Monoclonal antibodies,Tissue materials,Food and beverages,Biopharmaceuticals,Parenteral products,Mrna synthesis products,Vaccine components,Pharmaceuticals
- End products
- Sterile water for injection,Sterile iv solutions,Protein-based drugs,Biologics for infusions,Monoclonal antibody therapeutics,Lyophilized parenteral drugs,Mrna vaccines,Small molecule oral tablets,Injectable vaccines
- Steps before
- Raw Material Preparation,Sample Collection,Initial Quality Control,Bioburden Testing,Product Formulation
- Steps after
- Sterilization Validation,Packaging,Final Quality Assurance,Product Release
- Input ingredients
- filterable samples,non-filterable samples,antimicrobial products,pharmaceuticals,medical devices,parenteral products,raw materials,water,tissue materials,small molecule drugs,mRNA,biologics
- Output ingredients
- sterile pharmaceuticals,sterile medical devices,sterile parenteral drugs,sterile finished products,quality control documentation,regulatory compliance results
- Sterility Test Compliance
- USP <71>,EU Pharmacopoeia <2.6.1>,JP Pharmacopoeia <4.06>
- Detection Technology
- ATP-based technology
- Detection Time
- 5 days
- Filtration Method
- Membrane filtration / Direct inoculation
- Automation
- Automated detection and quantification
- Device Compatibility
- Steritest® System,Milliflex® Rapid System
- Microbial Detection
- Rapid detection and enumeration
- Test Result Accuracy
- Reliable sterility testing
- Packaging Compatibility
- Variety of drug packaging configurations
- Testing Environment
- Controlled
- Working mechanism
- Membrane filtration / Direct inoculation
- Automation level
- Automated / Manual
- Batch vs. continuous operation
- Batch / Rapid testing
- Integrated steps
- Sterility testing / Rapid microbial detection
- False positive/negative risk reduction
- Validated filtration devices
- Regulatory compliance
- USP / EU Pharmacopeia / JP Pharmacopeia
- Cleaning method
- Designed for use with laminar flow hoods / isolators
- System configuration
- Customizable for testing environments
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- System Configuration
- Sample,Packaging,Environment
- Market info
- Merck is known for its focus on life sciences, healthcare, and performance materials, offering products like pharmaceuticals, biopharmaceuticals, and high-tech materials. It has a strong reputation for innovation and quality in these sectors.