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  • FDA’s First Draft Guidance Under DSCSA – What It Tells Us And What It Doesn’t
    FDA’s First Draft Guidance Under DSCSA – What It Tells Us And What It Doesn’t

    On June 10th, the long-awaited first draft guidance under the DSCSA was released by the FDA.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 Whatever the intent, the draft guidance does provide some learning opportunities and also a very subtle call to action.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

  • 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.

  • 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.

  • Striving For Label Perfection In Clinical Trials

    No other labeling process in the pharmaceutical industry is as complex as clinical trial labeling. Clintrak Clinical Labeling Services knows this first hand and has been committed to finding a way to reduce the amount of time and money spent on proofreading in order to improve their process.

  • 3 Tips For Safe, Secure Healthcare Shipping
    3 Tips For Safe, Secure Healthcare Shipping

    All businesses need their shipments to go smoothly — nothing damaged, lost or late, and no last-minute surprises. And this is especially true in the healthcare sector, where a shipping mistake can cost not just dollars, but the health of a patient. By FedEx Custom Critical

  • Ensuring The Headspace Of A Vial Contains A Specific Gas

    When confronted with the task of ensuring that the headspace of a vial contains a customer specified gas there are several options available. However if the evacuation of atmospheric gasses and replacement with a specified gas is critical and must be verified, the challenge requires specialized equipment. By Bosch

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PRODUCTS & SERVICES

Pharmaceutical Container Closure Integrity Testing (CCIT) Equipment

Pharmaceutical Container Closure Integrity Testing (CCIT) Equipment

Increasing demands for Container Closure Integrity Testing (CCIT) in the pharmaceutical industry are driven by recent FDA guidelines , such as USP 1207, for sterile barrier.

Bosch Intermittent Horizontal Pharmaceutical Cartoner

Bosch Intermittent Horizontal Pharmaceutical Cartoner

The CUT 1405 intermittent cartoning machine is a consistent advancement of the successful CUT 120, which has proven its worth over many years. The new horizontal cartoning machine’s most impressive features are its especially economic design, maximum flexibility, superb ergonomics and ease of use, as well as the latest servo and safety technology.

Statistical Process Control Software: Sartorius ProControl Enterprise

Statistical Process Control Software: Sartorius ProControl Enterprise

Competitiveness is the order of the day. Systematic organization can be used to protect your processes from costly failures and unnecessary losses.

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.

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