Sterile and Nonsterile Cleanroom Garments, Particle Emission Testing, Sterile and Nonsterile Gowning: Part 2 – Operations
Introduction: Part 2
Cleanroom garments are worn by operators working in certified cleanrooms to protect the product and the processes inside the cleanroom from human sourced contamination and to maintain the integrity of the cleanroom. Selection and correct use of these garments has a significant impact on the performance of the cleanroom, an appropriate selection allows the use of lower air change rates as the contamination levels are lower.
This series of articles is intended to provide an overview of cleanroom gowning divided into four parts:
- Part 1: Materials and Components
- Part 2: Operational Aspects
- Part 3: Aseptic Facility Requirements
- Part 4: Aseptic Operational Aspects
- Change Frequencies and Garment System Configurations
Because the human body produces so many contaminants in such large quantities, the cleanroom apparel may be overwhelmed. Therefore, change frequencies and garment system configurations should be evaluated for the room cleanliness desired.
[Figure 1] Recommended Garment System Configurations Applicable to Various Air Cleanliness Environments (from IEST-RP-CC003 Garment System Considerations for Cleanrooms and Other Controlled Environments; reproduced courtesy of IEST)
Key:
- R = Recommended
- NR = Not recommended
- AS = Application Specific
Cleanroom Garment Laundering Process
The standardized cleanroom garment laundering process for reusable woven cleanroom garments is defined in IEST-RP-CC003.5 (IEST 2023), Garment Considerations for Cleanrooms and Other Controlled Environments. It specifies the linear process flow, closed loop service provided by cleanroom garment laundries.
Where cleaning is done in house the equipment used should be qualified, with the process for identification, documentation, inspection, repairing, collection, storage, cleaning, sanitizing packaging and distribution of clean sterile gowning procedurally controlled.
Soil Sortation
The soiled garments are retrieved from the cleanroom customer and transported to the cleanroom garment laundry facility. The cleanroom garment laundry facility sorts the garments by type and color, scans the garment if barcoded or notes the garment identification number, and performs an initial inspection. The initial inspection will identify garments that are unserviceable due to rips, tears, or stains. These garments are segregated, stain treated, repaired, or replaced.
Wash Process
The cleanroom garments are laundered in a programmable, stainless steel, bulkhead mounted, pass-through washer. When laundering garments for use in an aseptic environment the process is detailed addressing potential contamination risks—the soiled garments are loaded on the soiled side of the washer and unloaded in a certified cleanroom environment. The wash process consists of using filtered (1µm) softened or reverse osmosis treated water, in conjunction with filtered (5 µm) non-ionic surfactants (detergents). The final rinse water quality is multi-megohm (15-18 MΩ) deionized water filtered to equal to or less than 0.22 microns. The decontamination wash temperature is approximately 60° C or 140° F per Center for Disease Control (CDC) guidelines to kill and remove microorganisms and gradually reduced to room temperature using multiple rinses.
Drying Process
The specially fitted cleanroom dryers have incoming air passed through high-efficiency particulate air (HEPA) filters in one pass at a temperature of 60° C or 140° F and gradually reduced to room temperature. The washers and dryers are typically loaded at a less than 75 percent-rated capacity to assure thorough washing and drying of the cleanroom garments.
Inspection, Folding and Packaging
After drying, the cleanroom garments are inspected and folded. The garments are inserted into cleanroom compatible and gamma compatible packaging that meets IEST-STD-1248 cleanliness. The garments are folded in such a manner as to be easily removed from the package and donned in the gown room with minimal difficulty in the gowning process.
External Packaging and Delivery
The external packaging for shipment or delivery is based on the customer’s requirements and contractual specifications.
Gowning Management
Each item of reusable gowning should have a permanent identification mark and supporting record of inspections and repairs, and number of washes to ensure that it is replaced at the end of life.
Other Aspects
Facilities for staff will vary depending on local custom and practice—some countries will provide showering facilities and site uniforms for all staff—use of hand dryers in place of hand or paper towels is now a normal practice.
Hand washing—used in initial change areas
As COVID-19 has taught us there is a best practice for this:
- Wet hands with clean (potable) water
- Apply the recommended amount of soap
- Wash hands by rubbing them together being careful to wash the back of hands, between all the fingers and thumbs and under the nails—so all the skin is washed
- Wash hands for at least twenty seconds
- Rinse the soap solution from the hands
- The washroom should be fitted with HEPA equipped hand dryers—use these to dry hands
Note: Get input from employees about any fragrance or irritation issues - For change areas before aseptic processing areas use hand sanitizer, with hand sanitizing and changing at the “dirty” end of the changing room1, 2
View: Sterile and Nonsterile Cleanroom Garments, Particle Emission Testing, Sterile and Nonsterile Gowning: Part 1 – Materials and Components
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