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FEATURED ARTICLES

  • The Challenge Of Managing Regulatory Submissions & Correspondence
    The Challenge Of Managing Regulatory Submissions & Correspondence

    Life science organizations produce large volumes of documents necessary for submitting applications to regulatory agencies. They need to have records of those documents as well as all related communications from sites around the world. This creates a situation that can be rather daunting.

    Sponsors must first make sure all documents are going through the proper review and approval cycle and that controls are in place to meet regulatory requirements such as 21 CFR part 11. Once the documents are published and ready for submission to the regulatory agency, they are typically stored on a file share. Although that file share has access controls in place, it will not have granular-level access controls.

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WHITE PAPERS & CASE STUDIES

  • Meeting Accuracy And Safety Objectives With Inspection And Weighing Technologies
    Meeting Accuracy And Safety Objectives With Inspection And Weighing Technologies

    New approaches to selecting and using inspection and weighing equipment can help pharmaceutical processors better meet accuracy and safety objectives.

  • The Cost Of A Powder Stoppage
    The Cost Of A Powder Stoppage

    Operations managers cope with powder jams on a recurring basis. At least once a month, there may be a more significant event that brings production to a halt and seriously affects output for that day.

  • IMD-W™ Microbial Challenge Test Results
    IMD-W™ Microbial Challenge Test Results

    This fact sheet provides a summary of microbial test results obtained with the IMD-WTM-series instantaneous microbial detection™ system for water.

  • 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.

  • 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

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PRODUCTS & SERVICES

Rapid Microbial Detection System For Real-Time Water Monitoring Of Pharmaceutical Water

Rapid Microbial Detection System For Real-Time Water Monitoring Of Pharmaceutical Water

“The IMD-W system is one of the first of its kind to respond to a call from the pharmaceutical industry for on-line water bioburden analysis (OWBA),” said JeffreyWeber, PAT project manager at Pfizer and one of the founding members of the OWBA workgroup. He added, “BioVigilant’s IMD-W system is a new complementary tool at our disposal, for trending the state of control of water systems in real time through continuous bioburden monitoring.”

Used Lock Inspection Metal Detector

Used Lock Inspection Metal Detector

One (1) used Lock metal detector, type MET 30+, belt thru design, 2" wide x 1" high opening with 2" wide x 60" long belt conveyor, 115 vot, part#6050, serial# 6050/1, new 2001.

Used Safeline Metal Detector

Used Safeline Metal Detector

One (1) used Safeline metal detector, model DET-MET-SO2, 3" x 1" opening, on stainless steel stand.

Used Goring-Kerr Pipeline Metal Detector

Used Goring-Kerr Pipeline Metal Detector

ONE (1) Used Goring Kerr Type TEK21 Metal Detector Systems consisting of: TWO (2) 426 Pipeline Metal Detectors, 5" x 5" aperture with a 4" diameter x 31" long pipe, 110 volt, 1 Vicom Camera, with controls on base, Serial No. 46343/1.

Used Lock Inspection Metal Detector, MET 30

Used Lock Inspection Metal Detector, MET 30

One (1) used Lock metal detector, model MET30+, fall thru design, approx. 3.5" wide x 1.5" high opening, with reject, on portable stand with controls, serial# 5738/1.

Used CEIA Pharmaceutical Metal Detector

Used CEIA Pharmaceutical Metal Detector

One (1) used Ceia metal detector, model THS/PH21E, approximately 100 mm x 40 mm aperture, stainless steel enclosure with control panel, on stand with reject, serial# 21300205016, built 2013 and used for (2) months, comes with 6 month factory warranty to manufacturing defects from shipping date, 

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.

Pharmaceutical Isolator Equipment

Pharmaceutical Isolator Equipment

Pharmaceutical isolators are designed to the challenges and market requirements for low OEL containment systems in Pharmaceutical, Biotechnology, Medical devices, Radiopharmaceutical and Nuclear industries.  This technology is providing a safe working environment addressing both ergonomic and safety concerns for operators in research, manufacturing, testing and handling hazardous materials.  From aseptic applications, an environment capable of delivering a confident Class 100 (ISO 5) or better working environment.  This equipment can be portable or stationary or grouped to other isolators to form a “production system” or complete containment solution.  Isolators are designed to be tested and certified by their respective industry standards.  Our experienced staff has over 50 years of containment experience.  They serve on many professional societies’ boards and standards committees to keep in pace with new technology and industry requirements.

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