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FEATURED 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

  • 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

  • The Key To API Containment And Control

    When sampling and dosing active pharmaceutical ingredients (APIs) or high-potency APIs (HPAPIs), containment can be critical. Good laboratory practices (GLP) and the proper equipment designed and calibrated to facilitate GLP when transferring, mixing or blending APIs can reduce product waste, product contamination and minimize lost profit as well as create a healthier, contaminant free environment for lab operators. By Jason Frye

  • Drastically Reduced Isolator Decontamination Cycles

    With the use of catalytic aeration, M + P is able to reduce the duration of the aeration phase in isolators by about 50 %. The aeration phase is the most time consuming cycle during H2O2 decontamination. By Felix Henning, Optima Packaging Group GmbH 

  • Emerging Fourth Generation Pharmaceutical Containment Technologies

    Barrier technology has become overwhelmingly accepted as the basis for new aseptic processing facilities in 2013. The traditional clean room facilities of the 20th century are being rapidly replaced with advanced barrier based technology filling facilities. This technological evolution is dramatically reducing the risk of product contamination and risk of infection to patients. By Sterling Kline, RA IPS

  • 4 Factors To Consider For Effective Cleanroom Design

    You have been tasked by senior management to look into purchasing a cleanroom environment for a possible new product line. The mandate is that the cleanroom system provider must guarantee temperature, humidity, pressurization, and classification. As with any purchase, it is always best to be an educated buyer and have researched the options available to you. Knowing what questions to ask and what the cumulative effect is to those answers will make for a sound decision process and an overall successful project. By Rick Dobson, AES Clean Technology

  • A High Volume Process For Highly Potent (HP) Active Pharmaceutical Ingredients (APIs)
    A High Volume Process For Highly Potent (HP) Active Pharmaceutical Ingredients (APIs)

    This case study demonstrates how a commercial manufacturing partnership between Alkermes Contract Pharma Services (Alkermes) and a large pharmaceutical company resulted in the establishment of a high volume process for Highly Potent (HP) Active Pharmaceutical Ingredients (APIs).

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PRODUCTS & SERVICES

NFPA 654 Standards Industrial Vacuum for Combustible Dust Removal: A15DX

NFPA 654 Standards Industrial Vacuum for Combustible Dust Removal: A15DX

Cross-contamination can happen in tablet presses, capsule filling, milling, and polishing machines, pill de-dusters, and other equipment associated with pharmaceutical drug development and/or chemical production.  As powders, debris, and potent compounds within the environment threaten employee health and safety, they also threaten product purity. If you add the threat of combustible dust into the mix, you could potentially face something much worse.

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.

Flexible Curtain Pharmaceutical Barrier System

Flexible Curtain Pharmaceutical Barrier System

Isolation Systems, Inc’s premiere flexible enclosure system has been developed specifically for environmental separation. This system can be utilized to create any class of clean area from class 100,000 to class 10. The versatility of this partition system is such that its use within your clean area is only limited by imagination. Offered as our standard enclosure barrier on our soft wall systems, this product can also be configured to create hood enclosures, process separators, bench shrouds and to establish multi-class environments within the shared room area. Its unique anodized aluminum mounting track system is offered in three configurations- flat wall, in-jam and ceiling grid clip attachment, adding further to its versatility as well as its aesthetic appeal. Our standard system is offered in 40 mil polished and antistatic treated material. Optional thicknesses of up to 120 mil are also available. This extremely adaptable enclosure system will be custom tailored to your specifications. We assure your satisfaction with this unique product.

HEPA Filter Pharmaceutical Carts And Pass Throughs

HEPA Filter Pharmaceutical Carts And Pass Throughs

Unit construction:304 stainless steel with #4 finish.

Potent Compound Pharmaceutical Containment Isolator

Potent Compound Pharmaceutical Containment Isolator

Isolation Systems Glove Box Barrier Isolation Systems provide the highest levels of isolation and containment ensuring operator or product protection meeting current Operator Exposure Containment B and Levels 4 & 5.

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