Professional Documents
Culture Documents
Controlled
Controlled
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Table of Contents
Table of Contents.....................................................................................................................................................2
1.0 Purpose..........................................................................................................................................................3
2.0 Scope.............................................................................................................................................................3
5.0 References.....................................................................................................................................................3
1.0 Purpose
This procedure defines the usage, qualification, maintenance and control procedures for low airborne
particulate controlled environments.
2.0 Scope
This procedure applies to controlled environment facilities operated at the facilities of [Company Name].
3.3 Particle
An object of solid or liquid composition and generally between 0.001 and 1000 um in size.
4.3 Manufacturing
Responsible for ensuring that all employees working in the controlled environment are trained in
and comply with this procedure.
4.4 Facilities
Responsible for the construction, periodic maintenance and equipment required to meet this
specification and maintaining appropriate records of such activities.
4.5 Training
Responsible for providing the general training for this procedure.
5.0 References
Preventive Maintenance
Material Review Board
Test and Measurement Equipment
Controlled Environment Requalification Log
Cleaning Checklist
ISO/DIS 1464401,- 2, -4 Cleanroom and Associated Environments
Federal Standard 209E. Airborne Particulate Cleanliness Classes in Controlled environments and
Controlled environments, September 11, 1992.
7.1 Cleaning
Specific procedures for maintaining specified cleanliness class requirements are given in Work
Instructions. Best Practices for Controlled Environments: Airborne Particulates. Recommended
cleaning intervals are given below.
Table 1. Recommended Cleaning Intervals
Activity Per Shift Weekly Monthly
Ceilings and Fixtures X
Walls and Fixtures X
HEPA Filters and Panels X
Doors, Frames and Knobs X
Workstation Exterior X
Floors X**
Windows X
Sink X
Tacky Mats **
*or before each use.
** or more frequently, as needed.
Trends for environmental parameters will be established and examined. Quality Engineering and
Manufacturing Engineering will examine data for each month along with data from previous
months. Based on this data review recommendations, if required, for any changes or corrective
action to a specific controlled environment will be made.
8.3.1 Training
Employees working in the controlled environment will be trained on the contents of this
procedure. Successful completion of the training will be documented and maintained with
the employee's training records.
8.3.2 Materials
Materials used in a specific controlled environment facility will be compatible with its
environment. Before entry into the facility, packing materials should be removed from
material, and equipment should be suitably cleaned.
Note: The above conditions apply during any event, including maintenance, whether
scheduled or unscheduled.
If the specified limits have been exceeded, the controlled environment will need to be
cleaned per the normal cleaning requirements, and environmental controls checked until
compliance is achieved. When this happens, Quality Assurance will allow the supervisor
9.2 Documentation
Cleanroom facility supervision will maintain records of reusable garment cleaning. The record
will contain at minimum the date of cleaning, number of garments cleaned, who it was performed
by, and a signature.
10.2 Documentation
Incidents requiring requalification will be documented as required in section 8.3.2 Materials.