Aseptic processing is a high-risk operation in regulated manufacturing and personnel present the biggest risk to product contamination.

You can reduce human error and your level of risk by ensuring that you and your personnel fully understand the purpose and implications of working in a clean room environment and how to handle materials aseptically.

Operator-working-in-a-sterile-good-aseptic-practices-GMP-cleanroom

To address these needs, SeerPharma has developed this Good Aseptic Practices (GAP) course dedicated to training and upskilling personnel in the key principles of aseptic processing.  We’ll cover the critical topics listed below and the related risk management practices that should be employed.

Content

  • Introduction to Aseptic Practices and Sterility Assurance
    • PIC/S Guide to GMP, Annex 1 (Manufacture of sterile medicinal products)
      • and what to expect in the upcoming new version
    • USP <797> Pharmaceutical Compounding – Sterile Preparations
    • Medical devices to be supplied in a sterile state
  • Microbiological Aspects of Sterile Manufacture
  • How Cleanroom Design supports sterile pharmaceutical manufacturing
  • Aseptic Gowning Techniques
  • Operating in a Cleanroom
  • Validation of Aseptic Processing
  • Cleaning and Sanitation
    • including Environmental Monitoring
  • Sterilisation

Participants

Clean room personnel at Operator, Supervisor and Manager levels from pharmaceutical, compounding pharmacy or medical device industries will benefit from this training.  Whether you’re new in a clean room role or experienced and in need of refresher training, this course will help you gain critical knowledge of current industry expectations for clean room environments and operations as well as Good Aseptic Practices and why they’re enforced.

Format and Course Length

The 2-day course involves a lively mix of case studies / workshops and intensive tutorial sessions. The delivery method is collaborative with a small group and facilitator, which has been shown to enhance learning and critical thinking skills of participants. You will receive copies of all presentation slides and a Certificate.

Call us or click here to e-mail us and register your interest in a public session or having this course delivered on-site.

Refer to the Terms and Conditions