This article covers final considerations for medical device cleanroom equipment, storage, and finalized construction.
Cleanroom Viewing Window Design
The importance of strategically placed cleanroom windows is fully realized at final completion.
Cascading glass windows allow viewing into the production area and gowning room from outside the cleanroom. As we covered in Medical Cleanroom Construction Part 1, cleanroom windows provide external viewing and observation, but also make the room feel larger.
Workers inside the cleanroom feel more at ease and present when natural light passes by. Likewise, workers inside are able to stay more in tune with natural cycles of any work environment, such as shift changes, or interaction with coworkers outside the cleanroom. Finally, internal windows reduce the likeliness of collisions when moving between rooms.
Gowning Room Demarcation Line
A demarcation line represents the contamination barrier between the clean side (production environment) and “dirtier” entrances or gowning rooms. A bench sits between the clean and dirty sides of the cleanroom. After donning cleanroom attire, the operator swings each leg over the bench and dons a clean shoe cover before stepping over the demarcation line. The operator must be fully garbed and ready for production once stepping over the demarcation line, which helps visualize the separation between the gowning area and the primary cleanroom production area.
Medical Device Cleanroom Storage Essentials
Cleanroom garment storage cabinets provide construction materials suited for cleanrooms and sometimes other features such as integrated HEPA blowers and organization dividers.
Some facilities may require reinforced doors or mirrors as a protective measure.
Other cleanroom cabinets and shelving features include secure and non-secure storage options.
The mirror side of the door is convenient when self-checking the final fit of cleanroom garments and PPE before entry. The mirror sits flush mounted for easy cleaning and wide down.
Cleanroom storage cabinets provide many unique and custom configuration options depending on the task and materials at hand.
The advantage of an enclosed gowning cabinet is no different than that of an enclosed cleanroom: compartmentalization, process segmentation, and particulate capture during particulate-laden activities (donning apparel).
In less critical areas such as gowning rooms, a free-standing cleanroom gowning rack is an economical choice and easily adjusts for various shelf heights.
PAC provides a full lineup of cleanroom furniture for final outfitting. Our specialists identify appropriate furniture by considering ideal ergonomics, workflow, device handling, and chemical compatibility.
Cleanroom Wire Shelving
The wire cleanroom shelf rack is a simple solution for cleanroom storage. Wire shelving is more time consuming during cleaning, but beneficially, promotes airflow and has less surface area for particulate settlement.
Mobile wire cleanroom shelving is a benefit when cleaning under furniture or next to other large equipment. The shelf is low-weight and easily relocated during cleaning. High-quality stainless steel is the first choice for easy cleaning and corrosion resistance. Polymer cleanroom shelving is also an option when storing lightweight items. Metro Microban shelving helps keep storage areas “cleaner between cleanings” by promoting air passthrough and resisting microbial growth.
Conductive split sleeves and drag chains allow grounding when required for static control and ESD safe medical device packaging.
Cleanroom Passthrough Chambers
The finished gowning room includes a pass-through between the gowning room and the primary production room.
A cleanroom passthrough is an interlock that allows only one side of the chamber to open at a time. The mechanism prevents the free flow of air between the gowning room and the production area.
Items often undergo sterilization, ultrasonic cleaning, or disinfection with an IPA wipedown before entering the passthrough from the ISO 8 gowning room to the ISO 7 production room. Each inbound item undergoes a final inspection for packaging integrity or visible defects. It’s unlikely that an operator would detect trace contamination, hence a UV light test is sometimes an appropriate pass/fail test. Airshowers are among other tools for redundant particulate control and exfiltration.
Cleanroom Vestibules & Cart Passage
The double-door vestibule allows cart passage into the cleanroom. Carts are an important handling tool in every production environment. Small and medium-sized parts require organization and storage while passing through the workflow, before packaging, and before delivery.
Medical Device Cleanroom Build Guide
Part 1: Walls, Windows, & Containment
Part 2: Electrical, Mechanical & Partitions
Part 3: Fan Filter Units – Ceiling Grids
Part 4: VCT Cleanroom Flooring
Part 5: HVAC Design & Fan Filter Integration
Part 6: Pressure Differentials, Humidity and Temperature Calibration
Part 7: Cleanroom ISO Class Validation
The PAC Cleanroom Advantage
Facilities often choose PAC for cleanroom construction services because our vendor and manufacturing networks are not limited to any single brand-specific solution. PAC cleanroom expertise in your back pockets helps you overcome preliminary engineering challenges and consolidate your project management to a single point of contact.
Some panel and wall design styles are more appropriate in different scenarios. Depending on the size and sensitivity of the build. PAC builds each cleanroom to a style that best fits the existing facility with respect to current needs and future expansions. The style and configuration of your cleanroom is just one aspect of how a cleanroom comes to life.
If you’ve read the first 7 parts of this cleanroom build guide, you know there’s more to a cleanroom than the walls and partitions. A structural system is normally prefabricated and engineered by a cleanroom manufacturer after PAC provides preliminary engineering requirements. Everything else, such as the lighting, fan filter units, pass-throughs, air showers, doors, flooring, windows require application-specific selection.
Cleanroom contractors often call PAC when a cleanroom project requires general or special expertise on bulk component sourcing such as fan filters, windows, and doors. Because PAC sources nearly every component of the build directly from manufacturers at bulk pricing, our builds pass design freedom and cost savings to our customers.
The above items are just the bare essentials of a basic cleanroom operating system — equally important items include appropriate apparel, furniture, workstations, and task-orientated items. Sourcing and selecting qualified cleanroom production items is easier with the help of a specialist. Stock inventory is ready and delivered for startup including wipers, chemicals, disinfection systems, chairs, ergonomic fixtures, mirrors, dispensers, signage, ect.
The end-to-end advantage of a PAC cleanroom: it’s a turn-key system. You tell us what you need, and we’ll bring it to life — along with all of the critical cleaning supplies, furniture, and garments you’ll require on day one.
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