Company Group, Division, Location

[Company Name] [Company Group, Division, Location]

Document Title: Controlled Environments: Airborne Particulates

Document Number: [Document Number] Document Filename: [Document Filename]

CONTROLLED COPY/ MASTER COPY STAMP HERE

OTHER STAMP HERE

Revision Revision DCO/ECO Revision Level Date Number Description of Revision Author DRAFT DD/MM/YY YY-00000 Draft Author Name 1.00 DD/MM/YY YY-00000 Initial Release Author Name

COMPANY PROPRIETARY AND CONFIDENTIAL [Company Name] Controlled Environments: Airborne Particulates [Company Group, Division, Location] [Document Number] Rev x.xx DD/MM/YY

Table of Contents

Table of Contents...... 2

1.0 Purpose...... 3

2.0 Scope...... 3

3.0 Definition Of Terms...... 3 3.1 Airborne particulate cleanliness class...... 3 3.2 Controlled Environment...... 3 3.3 Particle...... 3 3.4 Work Instruction...... 3

4.0 Responsibilities And Requirements...... 3 4.1 Manufacturing Engineering...... 3 4.2 Quality Assurance...... 3 4.3 Manufacturing...... 3 4.4 Facilities...... 3 4.5 Training...... 3

5.0 References...... 3

6.0 Controlled Environment Specification...... 4 6.1 Identification of Controlled Environments...... 4 6.2 Controlled Environment Class...... 4 6.3 Required Equipment...... 4

7.0 Controlled Environment Cleaning...... 4 7.1 Cleaning...... 4 7.2 Documentation of Cleaning Activities...... 4

8.0 Controlled Environment Process Control...... 5 8.1 Controlled Environment Conditions...... 5 8.2 Environmental Monitoring...... 5 8.3 Controlled Environment Operations...... 5 8.3.1 Training...... 5 8.3.2 Materials...... 5 8.4 Interruption and Requalification...... 5 8.4.1 Interruption Conditions...... 5 8.4.2 Assessment and Correction...... 5 8.4.3 Documentation of Requalification...... 6

9.0 Apparel Requirements...... 6 9.1 Apparel Considerations...... 6 9.2 Documentation...... 6 9.3 Personnel Hygiene...... 6

10.0 Controlled Environment Maintenance...... 6 10.1 Maintenance in Controlled Environment Facilities...... 6 10.2 Documentation...... 6

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 1 of 5 [Company Name] Controlled Environments: Airborne Particulates [Company Group, Division, Location] [Document Number] Rev x.xx DD/MM/YY

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].

3.0 Definition Of Terms

3.1 Airborne particulate cleanliness class The level of cleanliness specified by the maximum allowable number of particles per cubic meter (per cubic foot, English) as determined by the statistical methods of Federal Standard 209E & ISO/DIS 1464401-2.

3.2 Controlled Environment A room or enclosure in which environmental conditions are controlled. Under this procedure, controlled environment means low particulate controlled environment.

3.3 Particle An object of solid or liquid composition and generally between 0.001 and 1000 um in size.

3.4 Work Instruction Under this procedure, work instructions shall apply to facilities designated as low particulate controlled environments.

4.0 Responsibilities And Requirements

4.1 Manufacturing Engineering Responsible for establishing the specifications contained within this procedure and coordinating with Facilities, Manufacturing and Quality Assurance on their implementation.

4.2 Quality Assurance Responsible for auditing the procedures for compliance and overseeing the qualification of the controlled environment and ensuring that the environment is appropriate for the products being manufactured. Also responsible for coordination of corrective action.

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.

6.0 Controlled Environment Specification

6.1 Identification of Controlled Environments Designated low particulate controlled environments will be identified. Under this procedure, requirements for class, cleaning, process control, monitoring, apparel, and maintenance will appear in work instructions or manufacturing instructions dedicated to each facility.

6.2 Controlled Environment Class Designated controlled environments will be classified in accordance with Federal Standard 209E & ISO 1464401 in units of 0.5 micron particles per cubic foot.

6.3 Required Equipment Equipment used in control and monitoring controlled environment facilities shall be selected and used in accordance with Federal Standard 209E & ISO 14644.

7.0 Controlled Environment Cleaning

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

Waste Baskets X** Work Stations and Equipment X* Portable Clean Booth X* Laminar Flow Booths X*

Sink X Tacky Mats ** *or before each use. ** or more frequently, as needed.

7.2 Documentation of Cleaning Activities Completion of cleaning activities, except per shift cleaning, will be documented in a log kept in each facility. Documentation will include date and time of cleaning, cleaning agents used, what cleaning was performed and initials of a member of the cleaning team. Quality Assurance and Manufacturing Engineering will review the log for completeness at least once per month.

8.0 Controlled Environment Process Control

8.1 Controlled Environment Conditions Limits for airflow, pressure, temperature and humidity shall be established and documented in the work instruction for each controlled environment facility. Type of sensor, placement, and monitor interval will be specified (N/A if not applicable).

8.2 Environmental Monitoring Monitoring of environmental parameters will be documented in a log kept in each facility. Quality Assurance and Manufacturing Engineering will review the log for completeness at least once per month. If any limits are exceeded during normal monitoring, Quality Assurance and Manufacturing Engineering will be notified, all production work will cease, and all work in process will be covered to the best extent possible.

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 Controlled Environment Operations

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.

8.4 Interruption and Requalification

8.4.1 Interruption Conditions The requalification of a controlled environment facility becomes necessary if any one of the following conditions exist. Quality Assurance should be notified immediately.

 Entry of improper parts, equipment or personnel or the breach of the air contaminant system (walls, duct work, etc.).  An interruption in normal airflow occurs that lasts for more than I minute.  Any of the specified environmental limits are exceeded.

Note: The above conditions apply during any event, including maintenance, whether scheduled or unscheduled.

8.4.2 Assessment and Correction Once a interruption is suspected, work will be halted in the facility. An assessment will be made against the specified environmental limits. If they have not been exceeded, this shall be recorded. Quality Assurance will allow the supervisor of the facility to resume normal operations.

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

of the facility to resume normal operations. Material in process during an incident requiring requalification will be placed under MRR and dispositioned.

8.4.3 Documentation of Requalification Any event that leads to a requalification will be documented in the Controlled Environment Requalification Log. Such a log will record the date, type of event, and the action taken for correction. Quality Assurance shall sign and date the log upon acceptance of requalification. When the log is full it will be reviewed for completeness by Quality Assurance, and filed.

9.0 Apparel Requirements

9.1 Apparel Considerations Apparel will be of quality and construction compatible with the cleanliness classification level of the controlled environment. Manufacturing instructions or work instructions will specify required apparel, which will be supplied, and proper gowning procedure. Apparel will consist of disposable or reusable garments or some combination of disposables and reusable garments. Disposable garments will be discarded when soiled. Reusable garments will be cleaned every week of continuous service by a qualified vendor or by captive means. Violation of apparel requirements is condition for facility requalification under Section 8.4 of this procedure. Repairs to damaged apparel must be made outside the controlled environment.

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.

9.3 Personnel Hygiene Personnel will be clean and free of air borne infections while using any controlled environment facility. Clothing must be compatible with required apparel. Finger nails, shoes, jewelry, use of cosmetics, and hair should be compatible with the specified environmental conditions.

10.0 Controlled Environment Maintenance

10.1 Maintenance in Controlled Environment Facilities When a facility requires maintenance or modifications, Quality Assurance should be notified. They will determine whether environmental limits will be impacted during maintenance. If so, requalification is required in accordance with section 8.4

10.2 Documentation Incidents requiring requalification will be documented as required in section 8.3.2 Materials.

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 5 of 5