Cleanroom Equipment

Cleanroom Equipment Needs To Have a Reasonable Design
When choosing cleanroom equipment, you should select materials that can provide a cleanliness level meeting the ISO 14644-4 requirements.

It is good to evaluate the suitability of cleanroom equipment in terms of the cleanliness of particles in the air.

The key to ensuring compliance is the correct selection of materials. The equipment needs to be smooth and cleanable, and have low particle emissions.

Storage cabinets, gowning cabinets, benches, and other change room furniture should use stainless steel or solid laminate. The seating should have a covering that does not absorb particles and a plastic covering.

The cleanability of cleanroom equipment
One of the most important aspects of choosing the right equipment for your cleanroom boils down to cleaning ability. The selected material must be able to withstand the harsh chemicals required for environmental disinfection. Stainless steel, aluminum, and powder-coated finishes provide the best protection against degradation caused by cleaning solutions. Many disinfectants can cause damage to products made of fragile materials, such as acrylic, PVC, polycarbonate, high-pressure laminate, and other synthetic products.

Replacement parts
If the equipment breaks down, you need to make sure that you have a backup on hand. Therefore, I recommend that you order important spare parts along with your initial purchase. Ask your supplier for the make and model of each piece of equipment and a complete parts list. Make sure they include the expected life of each component. It ensures that you will not run out of spare parts resources in the future.

Quality and cost of ownership
Although many companies are under pressure to minimize capital expenditures, you must consider both the initial operating costs of the equipment and the long-term maintenance costs of the equipment. You may pay more for higher-quality equipment, but in the long run, higher-quality equipment may save you from having to buy replacement parts and accessories in the end.

When considering the selection of materials and finishes for the cleanroom envelope, care must be taken to choose those that will provide the cleanability levels required to comply with ISO 14644-4. Equally important is the requirement that the equipment within the room meets compliance.

It’s good practice to assess the suitability of cleanroom equipment in terms of airborne particle cleanliness. Good equipment design will reduce the possibility of particle deposit in “dead” areas while well-designed garments will contain most particles.

The key to ensuring compliance is the right choice of materials. Equipment needs to be smooth, cleanable and have low particle emissions. To avoid passive particle generation, stainless steel is recommended in place of plated or oxide-coated steel.

Where possible, equipment within the room should have sloping surfaces. Smooth work surfaces, with minimal joints and radius edges, should be sealed to the structure with mastic/seals.

Storage equipment, step-over benches, and other change room furniture should be manufactured from stainless steel or solid laminate such as Trespa. Seating should have coverings that will not absorb particulates and plastic covered - fabric type should be excluded.

With so many key factors to consider, it’s important expertise is sought during design to ensure all areas within the cleanroom are efficient, safe and compliant.

Before any cleaning is done, make sure you are using the correct cleaning equipment, supplies, procedures and knowledgeable staff. Each class of cleanroom has its own specific cleaning equipment and solvents. Use lint-free, disposable mop heads, non-shedding wipes, plastic or stainless steel buckets and HEPA filter vacuums. Improper cleaning tools easily introduce microorganisms into the environment, resulting in the contamination of your cleanroom.

Once you have the proper cleaning equipment, you need a well-trained and educated cleaning staff to implement the proper protocols and procedures for a successful, robust cleaning program. Establish Standard Operational Procedures (SOP’s). Train your personnel in proper cleanroom protocol and disciplines, restricting items due to their contamination generating properties. Establish and maintain a good housekeeping and preventative maintenance program to incorporate the work areas, as well as, the cleanroom ceiling, walls, floors and equipment. Establish and maintain an on-going monitoring program for both viable / non-viable and ESD. These will be indicators of how well your area is doing and alert you to any negatives that occur. Make sure to create a check lists so that nothing is overlooked.

Your cleaning staff has to have a basic understanding of how the cleaning should be done and in what order and fashion. Always empty trash container first. Clean all general purpose equipment outside of the cleanroom and then cover with cleanbagging material. All small metallic and nonmetallic items must be cleaned with ultra-sonic cleaners and inspected for any obvious signs of contamination. Use all sanitizers in the proper amounts, methods and for specific allotted time. Use extra caution when cleaning the delicate ceiling HEPA filters. Failure to adhere to these basic principles will increase the amount of contaminants. Cleanrooms are classified according to the number and size of particles permitted per volume of air, and 0.5 micron particles are the most commonly measured size. These counts are directly linked to the bacterial contamination levels.

There are four main aspects to a cleanroom, which require very specific, routine cleaning processes; the ceilings, walls, surfaces and floors. Each is cleaned in a very particular manner to maintain its classification.

The ceiling should be cleaned from the top down using extended handle tacky rollers. In some cases it may be necessary to wet mop the ceiling with a self-wringing sponge or a flat mop, each having extendable handles. Occasionally, vacuum systems equipped with HEPA filters are used. Always use the proper blends of compatible solvents, such as; Di Water and Isopropyl alcohol, cleanroom compatible cleaners, and disinfectants.

When cleaning the cleanroom walls, using the hand wiping method is often the most effective. It’s recommended to use a dry, lint-free nonwoven or polyester knit cleanroom wipe, which if needed can be combined with solvents. These are best for being extremely low in particle generation and chemical extractables.

Typically most of your cleanroom surfaces are cleaned using hand wipes. Consider implementing wipe dispensers to make the storage and distribution of wipes easy while eliminating waste and cross contamination. The use of pre-saturated wipes with a blend of 70% Isopropyl alcohol and 30% Di Ionized water is very effective when wet cleaning is necessary. If static charge is a concern, ESD wipes employ carbon fibers within the knit fabric which undergoes a multitude of special processes that include cleaning, scouring, cutting, and a special proprietary cleaning process.

The same rules apply for cleaning floors as they do for the ceilings, except an edgeless string mop can be used. For these mopping systems, an autoclavable bucket and wringer is highly recommended.

Customers can feel the use of the real GMP cleanroom and the specific details of our products, including the construction process, design concept, product quality control, safety equipment, and after-sales service. They can fully reflect the engineering quality and professional and rigorous service attitude of Suzhou Pharma.
We have supplied more than 500+ clean rooms all of the world, the clients are from Germany, USA, Canada, European, Uzbekstan, Pakistan, Indonicia and so on. Except the turnkey project, we also can supply the clean equipments such as pass box, air shower, clean bench, laminar flow hood and so on, once you need the clean room project, we can give you A to Z service.