Pharmaceutical testing

A Biological Safety Cabinet (BSC), also known as a Biosafety Cabinet is mainly used for handling pathogenic biological samples or for applications that require a sterile work zone. A biological safety cabinet creates inflow and downflow of air that provides operator protection. The downflow air passes through an ULPA/HEPA filter and creates an ISO Class 3 work zone to protect samples from the risk of cross-contaminationTo guarantee the biological safety cabinet's optimum performance these are tested and classified by 2 standards: EN 12469:2000 and NSF 49.

Control Standard Endotoxin (CSE) is a widely used standard for endotoxin testing. It is a purified extract of E. coliO113:H10, the same strain used for the United States Pharmacopeia and the European Pharmacopeia reference standard endotoxin (RSE).

Our sterility testing Culture Media and Rinsing Fluids are a critical component of your Steritest™ solution. They provide the highest level of quality and testing confidence, they have been formulated and tested to meet the requirements of the USP <71>, EU Pharmacopoeia < 2.6.1> and JP Pharmacopoeia <4.06>. Steritest™ sterility Culture Media and Rinsing Fluids are manufactured in an ISO 9001, environmentally controlled production center. Each lot undergoes a stringent quality control (QC) procedure, including pH, sterility and growth promotion tests according to USP, EP and JP methods. Our manufacturing approach ensures the highest level of clarity for our culture media and rinsing fluids, therefore improving accuracy and significantly reducing the risk of incorrect interpretation and false results.

Granular media - GranuCult®, and powdered media - NutriSelect® with multiple quality control levels that comply with various standards such as EP, USP, JP, ISO, or FDA-BAM. Additionally, there are rapid culture media (chromogenic media): ChromoCult®, ReadyCult®, and FluoroCult®.

LAL reagents are primarily used to test for endotoxins in injectable pharmaceuticals, biological products, and medical devices. They are also used in renal dialysis centers and a wide range of other applications.Can achieve a maximum sensitivity of 0.001 EU/mL

The EZ-Fit® filtration system complies with water sample testing regulations and bioburden limits, adhering to international standards such as EP, USP, and ISO. The filtration system includes the EZ-Fit™ Manifold multi-branch filter holder, the quiet-operating EZ-Stream™ Pump, and various types of filter funnels (glass, stainless steel, plastic with membrane), along with the optional EZ-Pak® membrane dispenser.The filter membranes are available in pore sizes of 0.22µm, 0.45µm, and 0.8µm, made from various materials. Notably, the special PVDF membrane is used for samples containing antibiotics and antimicrobial agents.

- Microbial testing won’t be a burden when you use EZ-Fit® filtration units. The sterilized, disposable filtration devices for bioburden testing streamline your workflow, save time and give you highly reliable microbial enumeration results. 

EZ-Fluo™ is a non-destructive method that enables you to continue to grow the microorganisms after they have been stained in order to identify them using any standard ID technology. This is a tremendous advantage compared to other rapid test systems which cannot ID microorganisms using the same sample that was tested to detect the contamination

- The EZ-Fit® filtration system complies with water sample testing regulations and bioburden limits, adhering to international standards such as EP, USP, and ISO. The filtration system includes the EZ-Fit™ Manifold multi-branch filter holder, the quiet-operating EZ-Stream™ Pump, and various types of filter funnels (glass, stainless steel, plastic with membrane), along with the optional EZ-Pak® membrane dispenser.- The filter membranes are available in pore sizes of 0.22µm, 0.45µm, and 0.8µm, made from various materials. Notably, the special PVDF membrane is used for samples containing antibiotics and antimicrobial agents.

The Isolator facilitates the isolation of a product or process while providing the required sterile/aseptic environment. It is factory-configured to operate at positive or negative pressure in single or recirculating airflow. This equipment provides a comprehensive range of personnel and product protection in addition to the surrounding work areas and the environment.

LRW is specially processed water intended for reconstitution of LAL reagents and CSE, and to dilute samples and standards for LAL assays. Not for human or animal injection. LRW contains less than 0.001 EU/mL endotoxin and less than 1.56 pg/mL glucan.

- CRM Vitroids™ and LENTICULE® reference strains contain live microbial strains with confirmed concentrations (accredited according to ISO/IEC 17025), produced under standardized conditions, and reproducible in compliance with ISO 17034:2016 regulations.- Maximum number of generations: 3, cross-referenced with ATCC and WDCM – Shelf life of 16 - 24 months.

- CRM Vitroids™ and LENTICULE® reference strains contain live microbial strains with confirmed concentrations (accredited according to ISO/IEC 17025), produced under standardized conditions, and reproducible in compliance with ISO 17034:2016 regulations.- Maximum number of generations: 3, cross-referenced with ATCC and WDCM – Shelf life of 16 - 24 months.

S-Pak Filters 0.45 µm 47 mm white gridded are made from mixed esters of cellulose and have been optimized for MF method microbiological analysis of water or other liquids

S-Pak Filters 0.45 µm 47 mm white gridded are made from mixed esters of cellulose and have been optimized for MF method microbiological analysis of water or other liquids

Automated, rapid detection and enumeration of microbial contamination based on ATP bioluminescence

- The Milliflex Oasis® filtration system is used for testing water samples and bioburden limits. It includes: an all-in-one pump and filtration head; pre-sterilized filter funnels with an option for special PVDF membranes used for samples containing antibiotics, complying with USP <1227>; culture media compliant with the pharmacopoeia.- The filtration system reduces the risk of secondary contamination in line with recommendations from USP <61> EP 2.6.12 JP 4.05 part 1. Additionally, its traceability feature complies with USP <1117.

Our Pyroclear® Precision Pipette Tips are certified free of interfering endotoxins and glucans.

The Pyros Kinetix® Flex and Pyros® eXpress 21 CFR Part 11 compliant Software combine to provide a complete system for efficient, accurate endotoxin testing. The Pyros Kinetix® Flex tube reader is available in 96 eight mm wells. Each well has a detector that identifies changes in the optical density of a sample. In addition, each well is independently timed, allowing the operator to add more samples while a run is in progress.

Designed to integrate perfectly into all testing environments, streamlining your workflow, maximizing safety and convenience.