Sterile Products Manufacture

  • Overview
  • A-Z of Sterile Products Manufacture
  • Techniques for Failure Investigations
  • Pharmaceutical Microbiology
  • Good Autoclave Practice

NSF International has a global reputation for the quality of its training on sterile products manufacture. If you are involved in the development, production, quality control, quality assurance, batch review or batch release of aseptically prepared or terminally sterilized products, our training courses will give you the necessary knowledge of FDA and European Union regulatory and Good Manufacturing Practice (GMP) requirements for the manufacture and control of these products. You’ll also gain the technical understanding to be able to assess the risks associated with the manufacturing steps, the control measures needed to monitor and give assurance of product quality, and the confidence to investigate incidents and make decisions regarding the suitability for use and release.

A-Z of Sterile Products Manufacture

Your sterile products are your most valuable and your most risky. Lots can go wrong.

This highly interactive workshop covers all the regulatory requirements, industry trends and best-in-class practices from A to Z, including:

  • Design and qualification of all controlled environments from clean rooms to isolators
  • How to establish, monitor and control your environment efficiently
  • The design, validation and management of all utilities
  • The theory and practice of all sterilization methods from moist heat to VHP
  • Staff training, monitoring, management and leadership
  • Process simulations from design to failure investigations and risk assessment
  • Inspection and integrity testing of final containers
  • The latest regulatory and industry trends to help you prepare for the future

Techniques for Failure Investigations

Our course Risk-Based Decision Making in Sterile Products Manufacture teaches you how to handle “what ifs.” This course will help you sleep easy at night. We provide you with the processes, tools and techniques to make the right decision when things go wrong, no matter how challenging the problem:

  • High environmental counts in a Class A (viable and non viable)
  • Unexpectedly high pre-filtration bio burden counts
  • Drop in temperature and pressure during autoclave cycle
  • Filling room occupancy higher than has been simulated during media fills
  • HEPA filter integrity test failure during requalification
  • Sterile filtration of solution takes longer than is permitted in the manufacturing instruction
  • Higher than normal reject rate during visual inspection
  • High microbial counts on hands of operator detected at exit monitoring
  • Unplanned deviation from approved sterilizer loading pattern

We will give you the tools and techniques to solve these and other issues so you make the right risk-based decision…no problem. Tutors will coach you through the numerous case studies and problem solving exercises so you leave with the confidence to tackle anything and sleep easy at night.

Pharmaceutical Microbiology

Microbiological contamination of products and processes continues to be a major concern to the industry and its regulators. The potential impact of such contamination can be catastrophic. Put simply, microbial contamination can kill your patients and your business! This course, for non-biologists and microbiologists, is designed to provide you with the knowledge, confidence and decision making risk assessment skills to prevent this happening.

Key Learning Objectives

  • The basic characteristics of all microorganisms found in your premises – how they get there and how you can remove them
  • How to sample, isolate and identify these organisms
  • How to prevent contamination of your products and processes using risk management and assessment tools and techniques
  • Interpretation of data
  • QP decision making
  • Satisfying the regulator and protecting your patient
  • Understanding microorganisms
  • Understanding micro methods
  • Microorganisms and your products, procedures and plants

Good Autoclave Practice

Our course Good Autoclave Practice helps you protect your business. Without an efficient, well validated, managed and maintained autoclave you have no business.

We take you from cycle design, qualification and validation to maintenance management and troubleshooting. We cover the who, how, when, where and management and risk assessment of the “what ifs” when things go wrong. Our course is now in its 15th year, and our delegates tell us it’s the best course around.

You will also leave with what you need to:

  • Generate the best quality steam so vital to autoclave performance
  • Manage your contractors and third parties you depend upon
  • Validate your loads using a risk-based approach to make the most your resources
  • Get the most from you old equipment including trending of performance

Maintain good autoclaving practices -- get even more from your people, particularly those who prepare the loads and review the charts.

Upcoming Courses & Webinars

In Sterile Products Manufacture
  • “Excellent course, good balance of lectures and group based tasks.”Stephen Weetman / Wockhardt, UK
  • “Excellent! Tutors brilliant on all aspects of the course. Content was extensive and explained accurately with ‘real-life’ examples.”Rebecca Bent / Eli Lilly & Co Ltd, UK
  • “Complexity at right level. Confident and decisive tutors. Good intensity and pace. Particularly good buzz sessions.”Peter Clark / SCM Pharma
  • “One of the most fulfilling courses I have been on in 20 years’ plus experience.”Gary Cooper / Huddersfield Royal Infirmary
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