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WHITE PAPERS & CASE STUDIES

  • Blow-Fill-Seal For Biologics: Breaking Through The Glass Ceiling Of Pharmaceutical Packaging
    Blow-Fill-Seal For Biologics: Breaking Through The Glass Ceiling Of Pharmaceutical Packaging

    As the industry continues its move toward biologics, innovative solutions and technologies will be needed to ensure a safe and reliable approach to the manufacturing and delivery of these drugs. One option is to leverage the advanced aseptic manufacturing of blow-fill-seal (B/F/S) technology, which has the potential to address the challenges of traditional glass filling as well as the global distribution of biologics.

  • High Potency Containment For Polypeptide Vaccine Manufacturing
    High Potency Containment For Polypeptide Vaccine Manufacturing

    The team at Polypeptide Labs' overall project aim was to achieve homogenization (blending/tumbling) of potent lyophilized polypeptide product offloaded from a separate isolator.

  • Optimize Your Critical Cleaning Process And Ensure Results
    Optimize Your Critical Cleaning Process And Ensure Results

    Getting the best results from any cleaner requires proper mixing and cleaning procedures. This article includes mixing directions for aqueous cleaning detergent and methods for monitoring performance.

  • Cleaning Validation For Medical Device Manufacturing
    Cleaning Validation For Medical Device Manufacturing

    Cleaning validation or verification is a necessary regulatory compliance step in medical device manufacturing and reprocessing. Support from the cleaner manufacturer can save time and money.

  • Pharma Manufacturers Should Get Cleaning Validation Support From Supplier
    Pharma Manufacturers Should Get Cleaning Validation Support From Supplier

    Cleaning validation is a necessary and time-consuming part of manufacturing pharmaceuticals. The validation process can be expedited and cost reduced if the cleaner supplier can provide support.

  • Water For Injection Measurements

    Water is one of the most widely used raw materials in the pharmaceutical plant. Several grades of water are used throughout the plant. One grade, Water for Injection (WFI), is water purified by reverse osmosis or distillation as specified by the United States Pharmacopeia (USP). Specific tests for Conductivity apply to WFI Water produced on site for manufacturing purposes.

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PRODUCTS & SERVICES

Aseptic Processing: Consulting And Engineering Services Aseptic Processing: Consulting And Engineering Services

At a time when pharmaceutical manufacturing operations are under tremendous pressures to improve effectiveness, deliver quality and reduce costs, CRB's aseptic processing experts are creating innovative solutions for the handling of potent and non-potent compounds in aseptic environments.

Pharmaceutical Containment Systems And Equipment  Pharmaceutical Containment Systems And Equipment

For cost-effective implementation of containment requirements Mediseal relies on fast, optimal cleaning of pharmaceutical equipment.

Pharmaceutical Packaging for Small Lot Sizes Pharmaceutical Packaging for Small Lot Sizes

The trend towards small lot sizes has negative effects for the pharmaceutical industry. Up to 30% losses in terms of overall equipment effectiveness (OEE) are not a rarity.

Pharmaceutical Steam Sterilizer Pharmaceutical Steam Sterilizer

The FOF steam sterilizer series is the synthesis of Fedegari’s approach: work hard to create simplicity to you, without compromising performance. Fedegari guarantees the highest performances thanks to its experience and daily work with customers: engineering solutions, developing software and components.

Pharmaceutical Isolator For Sterility Testing Applications Pharmaceutical Isolator For Sterility Testing Applications

The FCTS Sterility Test Isolator has been designed for pharmaceutical samples taken from manufactured drug batches and meets all the requirements of the FDA, EMA, WHO and associated pharmacopoeia as well as all applicable EN standards and directives and international norms.

Pharmaceutical Isolator For Aseptic Filling And High Potent Active Ingredients Pharmaceutical Isolator For Aseptic Filling And High Potent Active Ingredients

The FCIS pharmaceutical isolator have been designed primarily for :

  • Pharmaceutical dispensing/handling of API and High Potent Ingredients
  • Assure sterile continuity after unloading sterile process machines
  • Guarantee aseptic filling during manufacturing phase.
Aerosol Microleak Detection System Aerosol Microleak Detection System

Emerson's Cascade Technologies is the global leader of packaging leak detection systems for the Aerosol, Food, and Pharmaceutical industries. The Cascade CT2211 aerosol microleak detection system is the first Quantum Cascade Laser (QCL) system developed for automated, in-line leak detection.

Dual-Input Intelligent Analyzer Instrument Dual-Input Intelligent Analyzer Instrument

Sensor input with an unrestricted choice of dual measurements. This multi-parameter instrument offers a wide range of measurement choices supporting most industrial, commercial, and municipal applications. The modular design allows signal input boards to be field replaced making configuration changes easy. Conveniently, live process values are always displayed during programming and calibration routines.

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