Liberty Industries Cleanroom Guide; Guide for a Clean Room …

Liberty Industries has been in the contamination control industry a LONG time, and they have MANY resources available at a range of prices to make sure your laboratory or specialized manufacturing area is top drawer. Some of these materials would be good to give to ALL personnel who are involved and, of course, especially all managers responsible for proper cleanroom cleaning procedures, regardless of your cleanroom classification.

So, as just one of the many cleanroom supplies you and your staff utilize, consider the following, described in greater detail at Libertys website, http://www.liberty-ind.com:

There is a WORLD of information in existence on everything from processes for cleanroom packaging to how to store and suit-up in cleanroom gowns to all the various steps to keep every square millimeter of your area within the required specswhich are many: ISO 3, ISO 5, ISO 7, ASHP, USP 797, SUP 797, Joint Association of Hospitals and NARD recommendations for risk level III sterile compounding, etc. However, here are just a few of the tips that may be of help:

Standard air flow

A conventional room is enclosed, has incoming air that is both conditioned and filtered to create a positive pressure within the room. This air comes in via ceiling diffusers and exhausts through the wall-mounted registers which is the air return to the A/C system. Under the specs of Federal Standard 209C, this room could produce a Class 100,000 environment, assuming personnel entering it maintain proper cleanroom attire, appropriate contamination control equipment is utilized, and there is a regular maintenance and cleaning procedure done to eliminate contamination which enters or is produced inside the cleanroom.

Non-unidirectional, semi-turbulent airflow

This type of enclosed, clean area also has air that is both conditioned and filtered, where the air comes in via a ceiling plenum. At that point, the air is diffused throughout the room by way of many slots in the flow-thru ceiling tiles. Then the air is pushed vertically at low velocities, and exhausts near or at the level of the floor. As with the conventional cleanroom, this style is able to make a Class 100,000 atmosphere to the specifications of Federal Standard 209C, and it also requires rigid personnel control, high-quality, specialized equipment, and a cleaning routine consistent with maintaining that level of cleanliness.

Non-turbulent airflow

This kind of enclosed, controlled environment has the treated air enter through a HEPA filter wall. The horizontal air velocity is 72-108 feet per minute (FPM) and its exhausted through an air return on the opposite wall. The design works for several class cleanrooms per Federal Standard 209C: Class 1, 10 or 100, with regard to the air upstream from the work area as, naturally, the air downstram depends on how contaminating the workstation is, though should exit via the return air wall. Finally, this room, as with all others, must be subject to rigid cleanroom techniques of the personnel, as well as a routine, diligent cleaning program.

Vertical, unidirectional airflow

This enclosed cleanroom design has the conditioned air enter by way of a HEPA filter ceiling. The filtered air moves straight downward at 72-108FPM as the design above, but the air is then exhausted via a grate system in the floor. Further, like the prior unit, it, too, can produce a Class 1, 10 or 100 atmosphere per Federal Standard 209C upstream from the work bench.

THIS design is generally thought to be the one to use for the optimum clean room but requires VERY stringent cleaning techniques, done continually as part of the operating process, in addition to specialized cleaning performed for each area in the cleanroom.

Particle numbers by class:

Max. no. of particles/ft > 0.5 and larger Class Max. no. of particles/ft > 5.0 and larger

Below is a helpful chart from Liberty regarding the appropriateness of which class cleanroom to what kind of air flow, in light of the material presented above.

Air cleanliness classes guidelines

Cleanroom with wall-to-floor airflow

Cleanroom with wall-to-wall airflow

Cleanroom with ceiling-to-floor airflow

Cleanroom with wall-to-open-end airflow

Cleanroom with non-unidirectional, turbulent airflow

In certain industries, performance is COMPROMISED when certain types of particulate is in the work environment. Examples are:

Many procedures have microminiature devices which are often found to be at risk with impurities such as dust, dirt, lint, skin cells, etc. of about .3 microns, as well as with the occurrence of temperature, humidity, static, etc. fluctuations. As a result, the cleanroom has evolved for both environmental and contamination control.

Your CLEAN ROOM, therefore, is an important factor to your facility regarding economic:

This can also include a dust-free enclosure, environmental chamber for testing (e.g. temperature, humidity, altitude, vibration, stability, etc.), specialty workstations, laminar flow tunnels, workstations, hoods, air showers, and the like. In all of those, rigid control is needed for optimal results. Therefore, technicians in anything considered a white room must be specially trained to regularly perform the right processes and in the right order.

Major sources for complications are:

According to the Austin Contamination Index (Encyclopedia of Clean Rooms, Bio-Cleanrooms and Aseptic Areas), heres what the typical tech generates in a room, even when fully-clothed and in appropriate cleanroom garments:

Particles given off/worker/minute by activity (.3 microns or larger)

To get the maximum performance from your cleanroom, the following should be considered a framework of parameters to obtain the specs YOUR process requires:

One of the most particulating factor in a controlled environment is the PERSONtheir clothing, shoes, hair, skin, etc.which emphasizes the need for stable, high-quality, specialized garments to achieve the cleanroom level your room requires. Appropriate wearability means that the garment resists breakdown and emits little to no particles, such as lint.

Synthetic materials are ideal for a clean environment because:

When choosing a quality source of clothing for lab techs to wear, here are some decision parameters regarding synthetic, low-linting or lint-free fabrics:

1. FROCKS, LAB COATS AND COVERALLS. Whether you decide on a lab coat or coverall thats disposable, or washable and re-usable, be sure to choose a simple design thats especially snug-fitting at the neck. Collars, pockets, darts, belts, pleats, and the like both retain and generate lint. Also, elastic around openings is key to a close fit. For the ultimate in cleanroom cleanliness, a coverall (sometimes called an overall or bunny suit) should be selected. The coveralls hood needs to be INSIDE the coverall so that particulate (e.g. hair, skin cells, and lint) falls into the coverall. Furthermore, the legs should be tucked into the cleanroom boots, boot covers or shoe covers so that all particulate is captured and doesnt get out to contaminate the cleanroom.

A frock is sometimes permitted in certain cleanrooms, but be aware that the downside of a frock is that the bottom is open which enables materials to fall to the floor. As a result, with the various activities by cleanroom personnel, that particulate is easily swirled up in air movement into the clean environment.

2. BOUFFANT CAPS AND HOODS. An important part of a critically clean environment, contamination control from the head must be addressed. A hood covers the head, neck, and ears and is tucked into the lab coat, frock, or coverall to catch slough from escaping. They fit snugly to cover all but the face (sometimes the eyebrows), utilizing elastic, snaps, and various sizes to fit well.

Some applications are suitable to using bouffant caps, which are typically made of cellulose, polypro, polyolefin, and Tyvek and are intended to limit particulating from head hair. Having similar limitations as a surgeons cap, they can cover the ears to some degree but note that gaps can allow dandruff, and other particles to fall to cleanroom work surfaces and floor.

3. FACE SHIELDS, MASKS, BEARD GUARDS, MOUSTACHE COVERS, ETC. Just as with other cleanroom garments, these items may also be necessary for your procedures. Certain lab operations require such materials around your laminar flow workstationsvertical flow, horizontal flow or cross flow, vertical fume hoods, biohoods, air curtains, and other cleanroom equipment. The same concepts apply: eliminate and contain any and all particulates.

4. FOOT COVERINGS. Because technical lab personnel may walk from a dirty parking lot with rain, mud or snow, then perhaps through a dusty manufacturing areainto your cleanrooms gowning area. Though they may use a shoe cleaning machine, no shoe cleaner can remove all contamination and no shoe bootie can completely capture dirt, dust or lint. As a result, your controlled area will degrade from a clean, ambient atmosphere to one battling contamination. This is why management of foot-borne particles is critical to maintaining your required cleanroom standards.

5. GLOVES AND HAND CARE. Hands introduce many complications to critical area, e.g. perspiration and skin oils, skin lotions, hair spray, fingernail polish and other cosmetics. Because technical workers have constant contact with your operations products, tools and equipment, the cleanroom facilities managers must not only establish and maintain strict procedures, they must choose gloves appropriate to the laboratory scenarios. Non-porous gloves become uncomfortable fairly quickly, yet perspiration can bleed through fabric, as well as through garment seams. Rubber gloves contain free sulphur and can cause chemical contamination. Be aware of such considerations when selecting the hand coverings for your personnel.

6. WIPES. Sometimes referred to as wipers, wiping cloths come in a wide variety of shapes, sizes and materials. The problem is: the more non-particulating the wipe, the less its ability to absorb or pick up liquids and particulate! They can actually SPREAD oil, grease, etc. rather than collect them. So, talk in detail with your representative at Midstates Marketing for help in determining whats best for your operation.

Reusable garments, sometimes called washable garments, can be a cost saver as compared to disposable garments, depending on the usage of the clean room. Just as a baby diaper service leaves a new supply when picking up the items needing laundering, a cleanroom laundry can provide that same convenience, whether its internal or external to your facility. However, a specialty laundry does not just offer garments that are free from dirt and spots, they give your contamination control staff clean, ready-to-wear cleanroom garments that are free of lint, dust and other particles, and all other types of contamination.

Laundry services giving super clean garments:

Naturally garments used in a laboratory or specialized-function white room must be kept separately from regular, manufacturing uniform laundry. Items needed for this procedure are:

All materials are to be kept clean continuously, but especially in dealing with the washed and dried garments. The staff handling them must wear cleanroom garments THEMSELVES and use all the techniques of a standard cleanroom during the washing, drying, folding, packaging, etc. operations.

It is important to have a clear idea the level of cleanliness you need your garments to be, in regard to the class of your cleanroom. Logically, the higher the degree of quality your garments must be, the more stringent the techniques that will have to be utilized in your laundering methods and, therefore, the more the process cost will be per garment.

There needs to be a separate set of machines for synthetic garments. Once washed, the garment goes from the washer to a dryer with controlled, clean, and filtered air. The dried garments are then packed in a sealed bagall within the laundrys controlled environment. At that point the garments are ready for delivery to the user or customer.

Because any cleanroom garment is intended to protect the product or process from the personnel involved, these laundry precautions are needed by any cleanroom garment manufacturer:

*An anti-stat surface agent is a static-eliminating chemical that is put into the last rinse cycle water so that it sticks to the garment surface when dried. Because it absorbs moisture from the air, the static is reduced, BUT if too much is added, anti-stat flakes will particulate from the garments into the cleanroom.

The phrase cleaned and packaged in a cleanroom used by launderable garment manufacturers refers to several factors:

However, having a quality cleanroom garment cleaned, dried and handled in the proper cleanroom process, packaged in the correct packaging for the appropriate class of cleanroom will be of little value if the cleanroom personnel do not dress appropriately for the cleanroom! Each lab technician must treat the garment correctlywear their cleanroom garment properly secure it at the neck, down the front, and at the wrist and ankles. If the garment is not worn correctly, contamination pours out of the exposed area into the cleanroom. As a result, testing of the cleanroom (e.g. with a particle counter) will show that that worker is causing the general room contamination level to go up.

The working specifications of your cleanroom facility will determine what regular schedule and how stringent a procedure to monitor the airborne contamination. Military specs, for example, call for CONSTANT monitoring while others may require monthly, quarterly or annually. The more the room is monitored, the better the record of contamination control, so cleanroom class will probably be a major factor. Industry governing requirements often state that the cleanroom atmosphere be monitored in an ambient, unoccupied state to use as for baseline data and/or, for a reading of an operational contamination level, while the room is occupied and working.

Airborne contamination is typically monitored in one of two ways:

As a public service, listed below are some terms and definitions of common components of a cleanroom, quoted from Liberty Industries Your Guide to a Clean Room Facility. Because this periodically is updated and changes, we recommend getting the most up-to-date version from the Institute of Environmental Sciences and Technology or another credible source.

Note: Much more information will be added to this page, including how to do contamination monitoring and verification, and more. Continue to check back periodically at http://www.rep.com for updates and added material.

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Liberty Industries Cleanroom Guide; Guide for a Clean Room ...