Developing SOPs for your Cleanroom
This hands-on workshop will train you how to develop Standard Operating Procedures (SOPs) based on IEST-RP-CC018: Cleanroom Housekeeping—Operating and Monitoring Procedures and ISO 14644-5: Cleanrooms and associated controlled environments—Part 5: Operations. In preparing their individual SOPs, attendees will learn how to determine and incorporate the specific provisions that apply to their cleanrooms. ISO 14644-5 specifies basic requirements for operations in all classes of cleanrooms used to produce various types of products. IEST-RP-CC018 provides guidance for maintaining a cleanroom at the level for which it was designed. Using these documents helps ensure that SOPs follow organized formats, and internal procedures will be based on tested, accepted methods.
Course outline Who should attend? Course materials Instructor
Course outline
- What is an SOP?
- Problems with SOPs
- ISO document format
- IEST Recommended Practices format
- SOP format
- Review ISO 14644-5 and prepare an SOP for personnel practices
- Review ISO 14644-5 and IEST-RP-CC018.4 and prepare an SOP for cleaning and sanitization
Who should attend?
You need to learn how to develop standard operating procedures because:
- You are a cleanroom manager
- You are involved in operations and quality assurance in your cleanroom
- Your cleanroom does not have a standard operating procedure for cleaning and sanitizing
- Your cleanroom does not have a standard operating procedure for personnel practices – protocols and gowning
Course materials
- Copy of IEST-RP-CC018: Cleanroom Housekeeping—Operating and Monitoring Procedures
- Copy of ISO 14644-5: Cleanrooms and associated controlled environments—Part 5: Operations
- Copy of PowerPoint presentation in a course binder
- Certificate of course attendance with completion of CEUs
IEST-RP-CC018.4 provides guidance for maintaining a cleanroom at the level for which it was designed. This document is intended as a guide for establishing appropriate housekeeping procedures essential for the overall contamination control program of the cleanroom. In addition, test procedures are provided for use in establishing the frequency of housekeeping and monitoring the effectiveness of the housekeeping. Test methods also are designed to help determine appropriate levels of surface cleanliness for specific cleanrooms.
ISO 14644-5 provides basic requirements for operating and maintaining cleanrooms and associated controlled environments to meet standards of the particular cleanroom as designed, built, and used. This standard addresses requirements that are basic to the operation of all cleanrooms regardless of the application.
Continuing Education Units: .6 CEUs
Instructor
Anne Marie Dixon