pharm-critical-environments-995x60 pharm-critical-environments-995x60

FEATURED ARTICLES

  • Heating And Cooling A Laboratory: Important Considerations For Equipment And Design
    Heating And Cooling A Laboratory: Important Considerations For Equipment And Design

    ASHRAE Standard 55-2004 determines the temperature, humidity and airflow which the average worker is comfortable; and though people in many industries have the luxury of dressing for the seasons, laboratory workers are usually burdened with an extra layer or two of protective garb. So, room atmosphere considerations also need to take into account that many laboratories have their own requirements as to temperature, humidity and airflow (ventilation). All of this adds up to a laboratory having very strict conditions of the facility’s internal air quality. By Brian Garrett, LEED Green Associate, Product Specialist, Labconco Corporation

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WHITE PAPERS & CASE STUDIES

  • Air Particle Counters Resistant To Vapor Hydrogen Peroxide (VHP)
    Air Particle Counters Resistant To Vapor Hydrogen Peroxide (VHP)

    The use of Vaporous Hydrogen Peroxide (VHP) is commonplace in the pharmaceutical industry for disinfecting sterile manufacturing cores. Since VHP is a strong oxidizing agent it can be damaging to certain internal components in optically based air particle counting instruments. The MET ONE series of air particle counters have been specifically designed to utilize materials that will not be damaged by exposure to VHP. The testing outlined in this paper demonstrates the resistance of these components and stability of the instrument over an extended period of exposure time.

  • Major Nutritional Supplement Manufacturer Increases Production With New Mixing And Blending System
    Major Nutritional Supplement Manufacturer Increases Production With New Mixing And Blending System

    A major nutritional supplement manufacturer needed to address the need for greater efficacy and additional capacity in the production of various products. Custom Powder Systems manufactured a 5000 Liter blender that fits and can be loaded and discharged within their limited manufacturing space and low ceiling heights.

  • Interpreting The Results After A Chemical Decontamination Cycle Performed With Vaporized Hydrogen Peroxide
    Interpreting The Results After A Chemical Decontamination Cycle Performed With Vaporized Hydrogen Peroxide

    The unexpected growth of a biological indicator (BI) at the end of a decontamination cycle is certainly an undesirable and problematic event.  What can and should be done at this point?

  • The Purpose And Application Of ISO 21501-4
    The Purpose And Application Of ISO 21501-4

    ISO 21501 is titled “Determination of particle size distribution – Single particle light interaction methods” and consists of 4 parts. Part 4: Light scattering airborne particle counter for clean spaces applies to handheld, portable and remote airborne particle counters used in cleanrooms.

  • Highlights On “Equivalent Time” F<sub>0</sub> Sterilization
    Highlights On “Equivalent Time” F0 Sterilization

    It has been experimentally shown that the reaction of thermal degradation of micro-organisms obeys the laws of a first order chemical reaction (i.e. like a chemical decomposition reaction) in which the reaction rate is proportional, in each moment, only to the amount of product still to be degraded (or decomposed).

  • Particle Testing in Cleanroom High-Pressure Gas Lines for ISO 14644
    Particle Testing in Cleanroom High-Pressure Gas Lines for ISO 14644

    This paper provides guidelines for the testing of high pressure gases used in cleanrooms according to the cleanliness limits derived from the ISO 14644-1 cleanroom classification standard, the FDA cGMP guidelines and the EU GMP Guidelines. Specifically, this applications paper relates to satisfying the air particle concentration limits of Class 100 (ISO 5) where product is exposed to the air environment.

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PRODUCTS & SERVICES

Pharmaceutical Sterilization and Depyrogenation Tunnels

Pharmaceutical Sterilization and Depyrogenation Tunnels

A uniquely simple, yet effective, method of loading pharmaceutical vials into the depyrogenation tunnel. 

Reduced Cycle Times In Isolator Systems

Reduced Cycle Times In Isolator Systems

An integrated and reliable biodeconatimination system is absolutely essential in isolators used to fill lines in pharmaceutical manufacturing. Quality and reliability are certainly important, but shortened cycles mean better economic success of the filling line.

AeroTrak® Remote Particle Counters With Integrated Pump

AeroTrak® Remote Particle Counters With Integrated Pump

AeroTrak Remote Particle Counters with Integrated Pump are ideal for use in any GMP-controlled area where continuous particulate and environmental monitoring is required. From the hot swappable sensor and pump assembly to the sample inlet capping auto-detect, AeroTrak Remote Particle Counter Models 6310, 6510 and the vaporized hydrogen peroxide (VHP)-resistant 6510-VHP have the features needed for seamless integration and easy maintenance.

Hydrogen Vapor Peroxide Bio-Decontamination Equipment

Hydrogen Vapor Peroxide Bio-Decontamination Equipment

The Bioquell Q-10 is a hydrogen peroxide vapor (HPV) bio-decontamination system which can be used to bio-decontaminate rooms, laboratories and hospital wards/units in a non-regulated environment.

Pharmaceutical Washing And Drying Equipment

Pharmaceutical Washing And Drying Equipment

Sanitize and dry containers or other process equipment including bins, drums, fluid bed drier bowls, down spouts, pallets and other parts with repeatable and validatable cleaning systems, designed to meet your specific cleaning requirements.

Used G&H Products Clean In Place System

Used G&H Products Clean In Place System

One (1) used G & H Products single tank CIP system, stainless steel construction, with 75 gallon holding tank 24" wide x 24" long x 30" deep, 2" tri-clamp side bottom outlet, with Ampco centrifugal pump, 30 HP 208-230/460 volt motor, 3540 rpm, with control panel and filter, mounted on stainles steel frame.

Used Martin Peterson Clean In Place System

Used Martin Peterson Clean In Place System

ONE (1) Used Martin Peterson CIP skid with 300 gallon stainless steel tank, heat exchanger, (2) basket filters, and circulation pump, mounted on common base, serial# M00077, new 2000.

Used Dober Group Clean In Place System

Used Dober Group Clean In Place System

One (1) used Dober Group CIP system, chematic design, stainless steel construction with (2) 1/2 HP circulation pumps, flow data control sensor, PLC controller and printer.

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