Ultra High-Volume Scanners

WHITE PAPERS AND CASE STUDIES

• Auto-Injector Assembly: Flexible And Scalable Production Is Key

  A range device assembly machine with the ability to implement several auto-injector formats, and allow rapid, tool-free changeover time of less than two hours provides a solution for PCI Pharma Services.

• R&D Services Company Implements A Collaborative Electronic Lab Notebook

  For a this BIOVIA customer, meeting collaboration demands meant being able to rapidly collect project information to deliver reports and data, fulfill patent submissions, or leverage and build on past work.

• Sulzer Mixers Designed To Tackle Digested Sludge

  Discover how a wastewater treatment plant solved its mixing problem that was caused by the high sludge content. 

• Ferring’s Strategic Approach To Content Management

  With a comprehensive software integration this specialty biopharmaceutical group created a highly connected environment for documentation in quality, R&D, and manufacturing.

• Regulatory Compliance: Weighing In Pharma Manufacturing

  Broad regulations, such as GMP, usually leave much to interpretation. This white paper explains which regulations are relevant and how to ensure compliance along the entire weighing product lifecycle.

• Zygo Accumold Case Study

  Accumold is a pre-eminent micro molding company experienced in fabricating precision micro, small, and lead-free injection-molded plastic components. Accumold relies on ZYGO coherence scanning interferometer equipment to maximize efficiency.

• Full Sail Brewing Taps Manufacturing Intelligence To Enhance Process

  Learn how a new filtration process helped Full Sail Brewing Company use water more efficiently while creating less waste and helping preserve a unique employee culture.

• Common Reasons For FDA Form 483 Observations And Warning Letters In Medical Device Environments

  By understanding the FDA’s updated approach to medical device regulation and the information provided in the inspection observations document, medical device companies can more easily identify and mitigate compliance issues.

• A Successful Approach For Managing Unexpected Increases In Potency For HPAPIs

  CDMOs face the challenge of managing new APIs in development projects with incomplete toxicity and pharmacology data. When a development project initially classified as an occupational exposure band (OEB)-4 highly potent API (HPAPI) had been later reclassified as an OEB-6 compound, the company upgraded a state-of-the-art containment production line to ensure operator safety and keep the project on track in less than one year.

• Aseptic Processing: How To Safely Handle APIs

  How can pharmaceutical manufacturers work with parenteral products to ensure the safe handling of APIs?

• Software Tools For Pharmaceutical Lyophilization Process Development

  Here, we describe a software modeling tool developed to optimize conditions for the primary drying cycle while accounting for heterogeneity within and between batches of drug products.

• A Guide to Annex 1 Requirements For Particle Monitoring

  The 2020 release of the EU GMP Annex 1 draft includes a new chapter on viable and non-viable environmental and process monitoring. Trend analysis and its impact on the contamination control strategy is now an essential activity referenced multiple times. There is also clear differentiation between qualification and monitoring, and quality risk management concepts are interwoven into each section.