Process Validation (Biopharmaceutical Products)

Sieves and screens are precision filtration and separation components designed for particle sizing, screening, and separation of powders, granules, and other process materials. Available in various mesh sizes, materials, and configurations, they support consistent particle separation and process control ac...

From early development, including mammalian cell line development, cell culture development, and process development, through to pre-clinical production and commercial supply, Patheon by Thermo Fisher Scientific provides CDMO services for protein-based biologic therapeutics. Patheon offers biotech and ...

The Pharma Servicdes / Lichtenheldt development Department (LDS) accompanies and advises our customers from product idea through galenic development and through the registration into the routine production. For product development and scale up Lichtenheldt has its own dedicated staff and laboratories, ...

BioDuro-Sundia’s process development services support drug substance production,  providing an efficient path to manufacture API or intermediates. Our extensive services support production of API for GLP toxicology studies, IND-enabling studies, clinical studies, and commercialization efforts. qq...

Blow-Fill-Seal is the most economical way to get your liquids or semi-solids into the perfect shape. But investing in your own equipment doesn't always pay off. For these cases, there is our CDMO service. This means that you have a complete GMP infrastructure, bottelpack technology in various configuration...

Fujifilm Wako provides monocyte activation test (MAT) reagents for pyrogen testing as an alternative of Rabbit Pyrogen Test (RPT). Our LumiMAT™ Kit is used to detect the presence of pyrogenic substances in pharmaceuticals and medical devices without the need for animal testing.
By using these sust...

As part of its commitment to full service support, PLD Pharma Services is pleased to offer our customers support with ANDA and NDA applications, including bio equivalency studies, collecting background data, supervising technology tranfers and reviewing applications to make sure that companies comply ...

Nelson Labs Europe offers a comprehensive approach toward Extractables & Leachables testing for the pharmaceutical industry. Our approach combines technical and analytical expertise, polymer knowledge and understanding of regulatory requirements, all combined in a tailored approach for our customers.

The TRH-100 is battery operated, micro-controller-based Temperature and Humidity indicator. Battery life is max. of 1 year with a standard 9VDC alkaline battery. TRH-100 is with magnetic keys for programming parameters, also having MIN./MAX function, which can be seen by using magnetic keys without opening...

The testo 174 mini data logger measures and logs the air temperature and relative humidity in storage rooms and offices continuously without interruption accurately and reliably.

·         Display of current temperature/ humidity value
·...

• Mesa develops, manufactures and markets, high-quality process validation and monitoring instruments and consumables. • Prochem BD 134 Or 121ºC - Ready to use Intended to evaluate the performance of the Air Removal (vacuum) system of Pre-Vacuum equipped Steam Sterilizers at  134 Or 121ºC ...

Turnkey Projects from Design to Supply, Installation, Commissioning and Qualification ( Biotech, High Potent API, Formulation, Nutraceuticals ) ·         Conceptual, Basic and Detail Engineering -Process, Utilities, HVAC & Clean Room, Production Subsys...

Glatt Pharmaceutical Services develops and produces solid pharmaceutical dosage forms. Our focus lies on multiparticulate systems such as pellets, micropellets and granules. Whether you are looking for optimal bioavailablity or taste masking, improved solubility or stabilization of the dosage form, we have...

Rubber sheets are flexible elastomeric materials used for sealing, gasketing, insulation, cushioning, and protection across a wide range of industrial applications. Available in various rubber grades, thicknesses, and sizes, they can be selected based on requirements for temperature, chemical resistance, f...

PUPSIT (Pre-Use Post-Sterilization Integrity Testing) assemblies are single-use fluid handling assemblies designed to enable integrity testing of sterilizing-grade filters after sterilization and before process use. Configured with compatible tubing, connectors, valves, and other components, they support a...

PP components are precision-molded or fabricated polypropylene parts designed for fluid handling, process equipment, and single-use applications. They offer good chemical resistance, durability, and dimensional stability, making them suitable for pharmaceutical, biopharmaceutical, laboratory, food & be...

Powder bags are specially designed single-use packaging solutions for the safe handling, collection, storage, and transfer of powders and dry materials in pharmaceutical, biopharmaceutical, food, and industrial applications. Designed to support convenient material handling and process hygiene, they can be ...

O-Rings are precision-engineered elastomeric sealing components designed to prevent the leakage of liquids and gases in static and dynamic applications. Available in various sizes, materials, and hardness grades, including silicone, EPDM, FKM, and other elastomers, they provide reliable sealing performance...

Inflatable seals and gaskets are specially designed sealing components that expand when pressurized to create a secure, tight seal between mating surfaces. Manufactured from suitable elastomeric materials, they accommodate dimensional variations and provide effective sealing in applications requiring contr...

Filtration solutions designed to remove particulate contaminants and support fluid and gas filtration in pharmaceutical, biopharmaceutical, food and beverage, and industrial processes. Available in cartridge, capsule, and vent filter formats, these products support process protection, fluid purity, and rel...