INSIGHTS ON QUALITY ASSURANCE

• When Clean Is Critical—Understanding Parameters And Definitions Of Clean

  Clean room environments necessitate high-quality materials and equipment that conform to a variety of specified standards. This white paper explains how clean parameters are defined and validated.

• Raman Spectroscopy Beyond The Lab: From Loading Dock To Production

  Raman spectroscopy offers a wide range of benefits in industrial and academic research, helping drive profitability in development, research, and quality control.

• Formulation Development: Determining Oxygen Sensitivity

  Pharmaceutical formulations, especially delicate large molecule biopharmaceuticals, may have some level of oxygen-sensitivity leading to degradation of the active pharmaceutical ingredient. Laser-based headspace oxygen analysis enables accurate, efficient determination of oxygen consumption curves. Accurate measurement of the oxidation rate supports the determination of headspace oxygen specifications and end-of-shelf life stability.

• Process Characterization And Validation For Biologic Processes

  Using a risk-based approach to generate an appropriate control strategy will help assure your product meets characterization and validation requirements, enabling timely approval and launch to market.

• Supply Chain Security; Focus On Raw Material Variability

  3/26/2020

  Qualifying two suppliers, increasing capacity, implementing a supplier scorecard, and surveying suppliers' number of production lines help guarantee supply — but close attention must be paid to raw materials.

• Business Continuity Program: Maintain Operations During Crises

  5/5/2020

  Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations, through a crisis situation.

• A New Way Of Looking At De-Nesting And Re-Nesting Solutions

  2/3/2021

  The emphasis for designing and manufacturing systems to handle drug container is on container integrity and gentle handling to prevent breakages and product losses. We have developed the innovative, automatic handling unit Nestor to process ready-to-use containers, such as syringes, to and from nests and tubs.

• The Value Of Reliability Assessments And Benchmarketing In Life Sciences

  12/21/2020

  A global medical device manufacturer sought to improve Safety, Equipment Reliability, Overall Equipment Effectiveness (OEE), and cGMP regulatory compliance by performing a plant-wide reliability and best-practice benchmarking assessment. The goal: perform a thorough reliability assessment and benchmarking against industry standards, OSHA, and cGMP requirements to establish a reliability roadmap for moving the organization into regulatory compliance and industry best practice performance

• A Guide To Weigh Cell Technologies For Food And Pharma Industries

  7/28/2020

  For parcel processing, as well as food and healthcare packaging, recent technology advancements have made in-motion weighing operations more precise and profitable. The latest and greatest catchweighers and checkweighers incorporate weigh cells featuring Electro-Magnetic Force Restoration, or EMFR. In addition, combining EMFR with AVC (Active Vibration Compensation) enables accurate product weight measurements.