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WHITE PAPERS & CASE STUDIES

  • 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 whitepaper includes mixing directions for each type of Alconox, Inc. aqueous cleaning detergent. It also describes methods for monitoring cleaner performance.

  • Why Medical Device Manufacturers Should Get Cleaning Validation Support From The Supplier
    Why Medical Device Manufacturers Should Get Cleaning Validation Support From The Supplier

    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 when establishing either cleaning validation or cleaning verification processes. This white paper outlines the basics of cleaning validation and how the cleaner manufacturer can help simplify and speed up the process, as well as support ongoing maintenance of the validated or verified state.

  • Why Pharmaceutical Manufacturers Should Get Cleaning Validation Support From The Supplier
    Why Pharmaceutical Manufacturers Should Get Cleaning Validation Support From The Supplier

    Cleaning validation is a necessary and time-consuming part of manufacturing pharmaceuticals. The validation process can be expedited and the cost reduced if the cleaner supplier can provide support — ultimately allowing pharmaceuticals to get to market faster and at a lower cost. This paper outlines the basics of cleaning validation and discusses the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.

  • 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.

  • Tighter pH Control In Chromatography & Purification Systems

    Biopharmaceutical Chromatography Systems are designed for separating and purifying proteins and bio-engineered products. The systems must maintain a hygienic design. Wetted surface finish must be < 20 μinch Ra and material traceability is important to maintain system integrity. pH measurement plays an important role in the purification process, providing feedback control of buffer and effluent feed through the column. The system’s wetted components must withstand Cleaned in Place (CIP) and Steamed in Place (SIP) cycles, which can stress a sensor with high heat and caustic. The pH sensor must be able to make accurate and stable pH measurements after the cleaning cycles.

  • Tighter pH Control In Biopharmaceutical Application

    In fermentation and cell culture, one of the most critical process challenges is to maintain the optimal pH level. Fermentation process utilizes a living organism such as a yeast, bacteria, or fungus strain to produce an active ingredient. Fermentation process is normally shorter in duration (2-7 days). Cell culture is a process in which a mammalian cell is grown to produce the active ingredient. The cell culture process is typically longer (2-8 weeks).

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PRODUCTS & SERVICES

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.

Conductivity Sensors Conductivity Sensors

The 140 series sensors are available with a range of cell constants, allowing optimum matching of the sensor to the expected conductivity. For low conductivity, choose the 142 sensor (available with either 0.01 or 0.1 / cm cell constants). For moderately high conductivity choose either the 140 or 141 sensors (both available with 0.2 or 1.0 / cm cell constants). The cell constant is accurate to within ±5 % of the nominal value, so the error in the measured conductivity will be at least ±5 %. For higher accuracy, the sensor must be calibrated by the user. A broad range of calibration standards is available.

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