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Cleanroom Masks

Criteria for Cleanroom Mask Selection

What does FDA  510k premarket approval mean? FDA 510k premarket approval means the FDA has examined the product and found the product and claims to be substantially equivalent to products that currently exist in the marketplace. You should only purchase a mask with an existing 510k, Precept was awarded their 510k in 1978.

What does BFE stand for? Bacteria Filtration Efficiency (BFE) stands for the ability for a mask filter material to filter out bacteria. All Precept masks offered by Tacy Medical have a BFE over 98%.

What does Delta P stand for? Delta P relates to how easy it is for a mask wearer to be able to breathe through the three mask material layers. Base on their Level 1, 2 or 3, Precept masks are correspondently easy to breathe through. When choosing a mask make sure you do not over protect yourself for the procedure or application desired. As the Level of protection goes up Level 3 vs Level 1 ,there is an increased difficulty for the wearer to breathe through the mask.

Level 1 Mask? This is the most appropriate level of protection for a mask used in the widest variety of ear loop mask applications. Great for healthcare professionals as well as patients and clinic visitors. Level 1 Precept masks include the PR.15118 and PR.15111.

Level 3 Mask? This level of protection is reserved for procedure applications where blood or body fluids are expected to be present. Not  suitable for general public. Precept offers the PR.15301 for these applications.

Three Ply Protection? There is no guarantee of protection just because a mask is listed as three ply. It is essential to know what the three plies are made of . They should represent an inner and out facing with a filter media in the middle. Using a 510k Mask like Precept ensures you are getting the Level 1 protection you deserve.

How do I get a secure mask fit on a small face? Most mask manufacturers have standardized on a ear loop mask size. This size accommodates the majority of North American faces but sometimes there is difficulty in fitting smaller faces. An adjustment can be made by twisting the ear loop before looping over the ear. This action will substantially tighten the fit on the face.

How do I reduce skin irritation during Spring and Fall?  Mask like medical gloves are a personal item , maybe even more so since they come in contact with our mucus membranes as well as skin. Precept conducts extensive raw material testing to insure the risk of contaminants is substantially reduced. However, there is not much that can be done during the allergy season. A reasonable approach would be to change your mask more frequently since there is a direct relationship to compromised inner facing and loose material threads causing the tickling sensation.

Interesting things about disinfectants.

Ready To Use is important because some regulatory agencies require testing  and validation of products that must be diluted.  Tacy Medical carries only Ready To Use (RTU) disinfectants.

Sticky Floors come from surfactants.  Surfactants are used to keep the disinfectant wet in the clean room environment long enough to reach the EPA registered required wet contact time.  Mopping with sIPA after the disinfectant has dried will transfer the surfactants from the floor to the mop head.  To avoid most of the double mopping consider TB1.  The TB1 one minute kill time reduces the need for surfactants in the disinfectant.  Both Peridox and TB1 are low surfactant disinfectants.

Eye Protection must be worn during monthly cleans.

Reducing Odor can be achieved by putting disinfectant on the mop head instead of the floor.  Disinfectant can be poured on a disposable mop head or the mop head can be immersed in disinfectant in a zip lock or magnetic bag.   Always dispose of used mop heads in a zipper or magnetic bag and seal the bag.  This keeps fumes from migrating into the cleanroom from the trash receptacle. Those who dislike the disinfectant smell may want to consider the Moldex 4801 (Small) or Moldex 4820 (MED/LG) charcoal filtered disposable mask.

Kill Data for sIPA is difficult to find but what little is published seems to indicate that sIPA doesn’t stay wet long enough in a high air exchange environment to achieve adequate kill for the daily disinfection of the ISO5. We recommend Sterile Peridox or Sterile TB1 32oz or Sterile TB1 Wipes


Testing Supplies

Both Plates and Paddles work for surface testing.   Plates are less expensive and cover more surface area but they are expensive to ship, have a short shelf life and are more sensitive to prolonged heat exposure.  Paddles have a longer shelf life, are inexpensive to ship and leave less residue on the contacted surface.

Personnel Testing can be expensive when adding a separate HD test kit.  All-in-one test kits reduce cost while meeting the testing criteria.

Wipe Testing is a should in USP800.  If wipe testing, consider using a certified lab.  This makes the test quantitative and data is defendable in court.   American Analytics is the Tacy preferred lab because it provides easy to read quantitative results and has been certified by multiple regulatory agencies.  Tacy Medical representatives have all the details.