Your Cleanroom Documentation Needs This
Maintaining your cleanroom ISO standards requires stringent documentation of cleaning procedures, monitoring systems and air quality checks. Total Source Manufacturing is here to offer some best practices for cleanroom documentation.
To begin with, it is important to remember that whatever classification a room has been declared is the level that must be maintained through cleaning and documentation. If a room has been certified as “Grade C” for example, it must be kept to that level throughout operations.
When keeping records of the potential microbial contamination and other particle counts in a cleanroom environment, it is important to be consistent. Regular monitoring is needed to record any changes or fluctuations.
Cleaning and disinfecting sterile compound areas in your cleanroom need to be carefully documented. The cleaning checklist needs to be done completely and in the same way each time to ensure thorough cleaning takes place.
Since different cleaning supplies are used for different purposes, employees need to know the proper use of each component. Identification labels for different compounds are a part of the cleanroom ISO standards and must be kept up to date and legible over time.
Having trained your employees on the proper cleaning, disinfecting and documenting procedures, it is now time to have those policies compiled in a handy reference guide for referral purposes.
Since cleaning practices will vary from daily to weekly to monthly to annually, you will need a calendar of rotational duties that can be completed and documented by your employees. Keeping employees assigned to these duties will help your cleanroom remain in compliance.
Paper or Web Documentation
Whether you choose to keep your policies, supplies, monitoring reports and other cleanroom documentation in paper format or by using digital quality management systems, it is a good idea to keep a full range of cleanroom documentation tools on hand. These cleanroom-specific supplies are absolutely essential in running an ISO certified cleanroom.
- Note pads – spiral bound on top or spiral bound on side
- Pens – black, blue or red
- Sticky notes – white
- Paper – blue, green, pink, white or yellow
- Hole-punched paper – blue, green, pink, white or yellow
- 3-Ring Binders
- Tab Dividers