Life Sciences
Aseptic Processing
  • Validation Readiness, Part 2
    Planning and pre-testing are keys to successful validation. Validation of a critical or precision cleaning process is a good idea whether or not there are specific regulatory requirements to do so. A validated cleaning and contamination control process is important in placing you above the competition.
  • Peristaltic Aseptic Filling Machines With a Single Use Production Philosophy
    New drug development is today focused largely on biopharmaceuticals rather than chemicals, which means that the resultant drugs tend to be injectable liquids instead of solids. Furthermore, the new drugs are typically designed for specific populations, hence batch sizes are smaller. Alongside these two trends there are ongoing pressures to increase efficiency, reduce costs, and minimize risks — including cross-contamination between batches.
  • When Worlds Don't Collide--But Ought To
    Pharmaceutical and medical device manufacturers tend to operate in separate worlds. The products are different; the cultures and customary manufacturing practices are different; the regulations are often different. For the successful manufacture of combination devices, there must be a harmonious fusion;1 so the two worlds collide, albeit with some reluctance.

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Mgmt & Safety
  • Critical New Product Development
    There are a number of critical timing issues that new product introducers should consider as they attempt to capture intellectual property rights and facilitate early sales.
  • Controlled Environments in Canada: A Business Perspective
    Canada has not been immune to the economic downturn of the past year. Even so-called recession proof industries have felt the effects of the decline, including pharmaceutical manufacturing. None of the business stories in Canada have had quite the affect on the psyche of high tech and cleanroom junkies as the demise of Nortel Networks, which filed for bankruptcy protection this past January. What was once the darling of the communications industry, and the anchor of the Canadian tech sector as Bell-Northern Research, is no more.
  • Lean Sustainability: Extending the Operational Excellence Paradigm
    There can be no mistaking that we are entering a new era in the pharmaceutical and biotech marketplace. The escalation of the pharmaceutical emerging markets in India, China, and the remaining BRICK nations has changed the landscape from both a strategic and tactical perspective. It has even spawned its own buzz word, called the “Pharmerging” markets. The progression of these markets has put unmistakable pressure on pharmaceutical companies to reinvent the way they think about product development, clinical efficiency, and manufacturing performance.

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Particle & Microbial Testing
USP 797
  • The Microbial Bioburden of USP 797 Compliance
    Simplifying environmental quality and control practices for pharmaceutical compounding Issued by the nonprofit United States Pharmacopoeia (USP) and endorsed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), USP Regulation 797 is the first enforceable standard for sterile compounding. Originally enacted on January 1, 2004, the latest revision became official on June 1, 2008.
  • Containment of Hazardous Drugs: The New Paradigm
    Compared to pharmaceutical manufacturing, hazardous drugs have a narrow definition in the world of pharmacy. This article will compare and contrast the differences in the approach and knowledge base that exists in both worlds, in terms of defining and coping with the hazards these drugs represent.
  • Cleaning Protocols for USP 797 Compliance
    Using the right techniques and procedures can make cleaning sterile compounding areas a matter of routine.

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Clean Packaging
  • Extrapolate To Production: Quality and Economics
    Let us assume there is a promising prototype for a critical product, a prototype for which we have reached the “ah-ha” moment. Perhaps half a dozen have been produced and pilot tested. If the product is a medical device, biocompatibility testing or even clinical trials may have started.
  • When Worlds Don't Collide--But Ought To
    Pharmaceutical and medical device manufacturers tend to operate in separate worlds. The products are different; the cultures and customary manufacturing practices are different; the regulations are often different. For the successful manufacture of combination devices, there must be a harmonious fusion;1 so the two worlds collide, albeit with some reluctance.
  • Key Considerations For Cleanroom Conveyors
    The case for modular conveyors

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Contamination Control
  • Art & Technology
    On the surface, critical cleaning/contamination control and art conservation seem worlds apart. Scratch the surface (or, better still, avoid scratching the surface) and you find parallels between critical cleaning and art conservation. As a point of clarification, conservation encompasses actions taken toward the long-term preservation of cultural property. In contrast, restoration is a type of conservation treatment. It specifically refers to an attempt to bring cultural property closer to its original appearance.
  • Cleanrooms and Energy
    Cleanrooms are expensive, and energy consumption is a major cost item in operation and maintenance. Some costs may be required, and expecting individual companies to challenge long-accepted design rules is unrealistic. As energy costs increase and companies strive to reduce their carbon footprint, planning and, if needed, redesigning the cleanroom can be a rewarding investment.
  • Changes Affecting EU GMP and The FDA's CGMP Non-Viable Particle Cleanliness in Cleanrooms
    What the revisions to ISO 14644 may mean to your cleanroom EU GMP and the FDA’s cGMP set the target cleanliness levels for non-viable particles in pharmaceutical cleanrooms. Both documents refer the reader to ISO 14644 for the methods to determine these cleanliness levels.

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Regulations/Standards
  • Point of View: Gauging Regulatory Effectiveness
    That the pharmaceutical and biotech industry is in a state of flux is undeniable. Shifts within the U.S. marketplace have intensified the pressures on industry to perform, while the FDA has been struggling with its own charter. For both industry and regulatory, their raison d’être is clear. Each must find a way to make sure the drug therapies approved for the public are safe and efficacious, and they must do it efficiently. The FDA’s effort to focus on scientific rigor rather than compliance overhead is well underway.
  • Beyond NIST-Traceability: What Really Creates Accuracy
    “NIST-traceable” is often invoked as though it has some sort of magical metrological power, imparting accuracy to all it touches. In reality, it is only one of several elements of good calibration. What’s worrisome in the practice of equating NIST-traceability to accuracy is the perception that it supersedes the other, equally important elements of calibration.
  • The Devil Is In The Details
    Consolidation on a massive scale amongst the elite of the U.S. pharmaceutical industry raises questions about how to remain competitive, and profound changes to the marketplace can be seen on all fronts. On the regulatory side, the FDA’s transformation from an overhead-intensive approach to quality to one based on scientific rigor is well underway. What this will ultimately mean to brand and generic pharma is still unknown, but there can be no doubt that the levels of scientific rigor and document traceability will need to be higher than ever before.

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