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FEATURED ARTICLES

  • FDA’s First Draft Guidance Under DSCSA – What It Tells Us And What It Doesn’t
    FDA’s First Draft Guidance Under DSCSA – What It Tells Us And What It Doesn’t

    On June 10th, the long-awaited first draft guidance under the DSCSA was released by the FDA. For those holding high expectations that the guidance would offer specific direction on how to handle suspect/illegitimate products internally, you may come away feeling a little shortchanged. However, in the past, the FDA has come under scrutiny for using guidance to replace rule making, since this requires legislative involvement, so the lack of detail in the draft may be an effort to make room for flexibility that industry felt they weren’t getting before. Whatever the intent, the draft guidance does provide some learning opportunities and also a very subtle call to action. I recently spoke with David Colombo and Dawn Wang with KPMG Life Sciences Advisory to find out what can be learned from this draft and where we go from here.

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WHITE PAPERS & CASE STUDIES

  • Container Closure Integrity Testing Of IV Bags
    Container Closure Integrity Testing Of IV Bags

    As a means to ensuring the safety of sterile products, the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) have provided strict guidelines for the testing of container closure systems.

  • High-Speed Pharmaceutical Glass Vial Inspection With In-Sight Vision Systems
    High-Speed Pharmaceutical Glass Vial Inspection With In-Sight Vision Systems

    Few industrial sectors have such stringent quality requirements as the pharmaceutical industry. To meet these exacting specifications, companies are increasingly utilizing intelligent vision systems.

  • Exceeding GMP Of Medical Devices At Each Step In The Production Continuum

    Through years, ATL has emerged as a leader in the manufacture of disposable medical devices. ATL is an FDA-registered medical device company whose custom disposable medical components are manufactured and shipped worldwide.

  • Pharmaceutical Company Cuts Packaging Costs
    Pharmaceutical Company Cuts Packaging Costs

    In tough economic times, First Priority, manufacturer of generic veterinary pharmaceutical products, decided it was time to take a hard look at where they could cut costs without compromising on efficiencies and quality of their products.

  • Effective Cleaning Of BOD Bottles

    Many environmental water/wastewater laboratory professionals are faced with the task of cleaning BOD Bottles. The interiors must be cleaned and rinsed completely to remove any inhibitory residues which may interfere with future tests. As these bottles have constricted necks, hand cleaning is difficult and time consuming. By Miele Professional

  • A Step-by-Step Guide to Implementing An Effective Track-And-Trace Program

    Although a universal standard for pharmaceutical track-and-trace solutions has yet to emerge, the California Board of Pharmacy’s ePedigree requirements are currently driving action in efforts toward implementing serialization to provide supply-chain integrity to the public. At Aphena Pharma Solutions, we have developed a step-by-step process that has helped us establish a very effective track-and-trace program.

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PRODUCTS & SERVICES

Used Klockner Sachet Filling Machine

Used Klockner Sachet Filling Machine

One (1) used Klockner Mediseal LA160 Sachet filler. Set up for liquid/gel filling and a powder filling feeder and attachment are included with adapter plates for quick change over. 

Versa Rx High-Accuracy, High-Rate Checkweigher

Versa Rx High-Accuracy, High-Rate Checkweigher

The Thermo Scientific Versa Rx checkweigher provides superior quality to meet the most demanding performance standards.

Versa RxV Pharmaceutical Checkweigher with Integrated Track and Trace

Versa RxV Pharmaceutical Checkweigher with Integrated Track and Trace

The Versa RxV checkweigher enables manufacturers to print and verify codes that can be used for either unit level or lot level traceability, thus helping to keep the drug supply chain safer.

 Pharmaceutical Barcode Readers

Pharmaceutical Barcode Readers

Cognex offers the most advanced technology available for 1-D barcode and for 2-D Data Matrix code reading. Regardless of the barcode symbology, size, quality, printing method, or surface the codes are marked on, we can read it!

Used Garvens Checkweigher

Used Garvens Checkweigher

One (1) used Garvens Automation Check-Weigher, Type SL2-PM. With 200 grams capacity, 42" long x 2" wide conveyor, and digital controls; 230 volts. Serial #8536, new in 1994.

Pharmaceutical Molding And Sealing Machine For Packaging

Pharmaceutical Molding And Sealing Machine For Packaging

The Omni FS is used for the molding, cutting and punching of primary packaging materials.

Pharmaceutical Liquid Tube Filling And Closing Equipment

Pharmaceutical Liquid Tube Filling And Closing Equipment

The tube filling and closing system is suited for the dosing of liquids in a filling range from 50 to 5000 ml.

Aseptic Double Bagging Machine (Syringes Or Vials)

Aseptic Double Bagging Machine (Syringes Or Vials)

Tubs sealed with Tyvek loaded with sterile syringes or vials are automatically fed to the machine from the upstream machine.

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