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

FEATURE ARTICLES

  • ArmorFlex® 110 Film Frequently Asked Questions

    At ILC Dover, we are always "creating what’s next" by listening carefully to our customers. In response to customer input and emerging regulations, we've developed a robust new film to support our DoverPac® Containment Solutions line. This revolutionary product, ArmorFlex® 110, delivers permanent static dissipative properties while meeting FDA and 2002/72/EC requirements for food contact.

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WHITE PAPERS & CASE STUDIES

  • 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?

  • 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.

  • How To Optimize Your Weighing Process
    How To Optimize Your Weighing Process

    Many factors found in the laboratory can influence the behavior of a balance. Learn how to anticipate and regulate them to achieve the ideal settings for your balance and the most reliable weighing results. By Michelle Sheridan, Sales Specialist, Premium Weighing Sartorius Corporation

  • 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

    Maik W. Jornitz, President, G-CON Manufacturing LLC

    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

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PRODUCTS & SERVICES

Pharmaceutical Advanced Barrier Systems for Solid Dose Applications

Pharmaceutical Advanced Barrier Systems for Solid Dose Applications

The requirements concerning the safety of machine operators are a key issue in this day and age. The “Advanced Barrier System” (ABS)” is a safety concept that serves the operator and the product. It is used for the safe processing and filling of highly active and toxic products. In addition, it offers a safety level that can be validated, and it prevents the uncontrolled spreading of dangerous substances.

Used Howorth Pharmaceutical Glovebox Isolator

Used Howorth Pharmaceutical Glovebox Isolator

One (1) used 78" Howorth isolator, 316L stainless steel constructin, single sided, 78" long x 24" deep x 33" high chamber, (4) gloves, bottom discharge with weigh station, xp rated, class 1, div 1, group d on stand with controls, serial# 1000-GA-4370.

Used LaCalhene Pharmaceutical Isolator

Used LaCalhene Pharmaceutical Isolator

One (1) used La Calhene rigid wall isolator, stainless steel construction, single sided with (3) gloves, serial# AIR-1522

Used ILC Dover Softwall Flexible Isolator

Used ILC Dover Softwall Flexible Isolator

One (1) used Dover soft wall isolator, approximately 36" wide x 24" deep x 33" high, single sided with (2) glove ports, 12" and 8" end ports with stainless steel frame.

High Containment Pharmaceutical Rapid Transfer Ports

High Containment Pharmaceutical Rapid Transfer Ports

316 Stainless Steel Construction

Pharmaceutical Explosion Proof Double Tier Fill Transfer Isolator

Pharmaceutical Explosion Proof Double Tier Fill Transfer Isolator

All Isolation Systems, Inc. isolators are designed, engineered and manufactured to the highest standards, fully utilizing state of the art design and manufacturing processes. Complete as built drawings are submitted to our customers for their approval prior to manufacturing to assure total compliance with their requirements and specifications. Upon completion each isolator is fully tested for seal integrity and performance. A complete installation, operation and maintenance manual is provided including all test and certification reports, electrical and control schematics, certified final drawings, replacement parts lists, and component specification sheets, sufficient to compile your IQ’S , OQ’S and SOP’S. Isolator testing and validation protocols and procedures are available for your review upon request.

Class 100 Pharmaceutical Portable Transfer Cart

Class 100 Pharmaceutical Portable Transfer Cart

Isolation System, Inc. has designed and engineered the PTC System, with careful attention to user needs. This system has been developed to ensure effective material and product transfer between clean areas and process stations. Its rugged solid stainless steel construction protects against wear in high-traffic applications and provides long-lasting aesthetic appeal. This system can be supplied to operate under either positive or negative pressure conditions, recirculating or single pass air flows and returns. Adjustable shelves allows for multi-product and con-tainer size applications. Coved interior corners provides for easy cleaning and decontamination between uses. System can be operated under DC power or AC . DC power source is completely rechargeable . This product may be easily customized to fit your specific needs and process transfer requirements.

Pharmaceutical Air Shower, DownFlow Cart Entry System

Pharmaceutical Air Shower, DownFlow Cart Entry System

Isolation Systems, Inc. has designed and engineered the ASCE System, with careful attention to user needs. This system has been developed to ensure effective bulk material decontamination blow off prior to transfer into clean areas. Its rugged solid stainless steel construction protects against wear in high-traffic applications and provides long-lasting aesthetic appeal. Sensor activated cycle automatically washes product with high-velocity air prior to material introduction into clean area. Low wall air returns effectively capture dislodged contaminants through both pre- and final-filtration banks. This product may be easily customized to fit your specific needs and process requirements.

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