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

WHITE PAPERS & CASE STUDIES

  • 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.

  • Rouge & Biofilm: Compounding Cleaning Challenges
    Rouge & Biofilm: Compounding Cleaning Challenges

    Rouge may facilitate the development of more tenacious biofilms. Both rouge and biofilm represent cleaning and decontamination challenges to manufacturers. By Michael Gietl and Paul Lopolito

  • Variability In Sterility Test Processes And The Benefits Of Modular Workstations
    Variability In Sterility Test Processes And The Benefits Of Modular Workstations

    A review of the current operational practices that incorporate sterility testing and provides an insight into the role of hydrogen peroxide vapor bio-decontamination and continuous particle monitoring.

  • Be In Control Of Product Quality – Do Not Just Rely, But Understand
    Be In Control Of Product Quality – Do Not Just Rely, But Understand

    Past experiences have shown that too often product quality is based on sole reliance of vendor certifications, statements and promises. To diminish such reliance new technologies started to be implemented, like process analytical technologies (PAT), process controls, automation etc. often once again overexerted as the solution to all problems. Activities that supposedly result in higher product quality due to better process controls. Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing LLC

  • Hydrogen Peroxide Decontamination: Vapor Vs. Aerosolized Systems

    When facing a microbial contamination challenge, hether from multidrug-resistant organisms in a hospital or in bio-pharmaceutical production facilities, not all hydrogen peroxide-based decontamination systems are the same.

  • Monitoring Chemical Processes For Early Fault Detection Using Multivariate Data Analysis Methods

    Multivariate statistical methods can be used to monitor process variables and predict final product quality at an early stage, while also providing deeper understanding of the process. This allows engineers and production managers to optimize their processes, thereby realizing significant cost and time savings. By Dr Frank Westad, Chief Scientific Officer, CAMO Software

More White Papers & Case Studies

PRODUCTS & SERVICES

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 Feldmeir Clean In Place System

Used Feldmeir Clean In Place System

One (1) used Feldmeier Clean-In-Place system, dual tank design with (2) approximately 500 gallon stainless steel tank, heat exchanger, circulation pump, diaphram pump on common stainless steel base.

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.

Used Custom Stainless Steel Fabricating CIP Skid System

Used Custom Stainless Steel Fabricating CIP Skid System

One (1) used Custom Stainless Steel Fabricating CIP Clean In Place skid, 316 stainless steel construction, consisting of: (1) approximate 50 gallon tank, (2) spray balls, top man way with cover, coned bottom with sump style outlet, (1) Yula U tube heat exchanger, shell & tubes rated for 150 psi at 40 to 350 f, serial# , built , (1) Fristam centrifugal pump, model , serial# , driven by a 5 hp motor, (1) Fristam centrifugal pump, model , serial# , driven by a 3 hp motor, (1) Control panel, and miscellaneous piping, and valves, mounted on a stainless steel frame.

Used Electrol Specialties Clean In Place Skid System

Used Electrol Specialties Clean In Place Skid System

One (1) used Electrol Specialties Company CIP Clean In Place skid, 316 stainless steel construction, consisting of: (1) approximate 50 gallon tank, (2) spray balls, top man way with cover, coned bottom with sump style outlet, (1) Yula U tube heat exchanger, shell & tubes rated for 150 psi at 40 to 350 f, serial# 17573, built 1997, (1) Fristam centrifugal pump, model FPX722-140, serial# FPX722995173, driven by a 5 hp motor, (1) Control panel, and miscellaneous piping, and valves, mounted on a stainless steel frame.

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