| What is the shelf life for Berkshire’s sterile wipers? |
A three-year shelf life has been identified for Berkshire’s dry and pre-wetted sterile wipers. The irradiation date is located on each Certificate of Sterility. Take that date and add 3 years in order to determine the shelf life.
Even with a known shelf life it is highly recommended that before use, the primary packaging is inspected to ensure there are no holes or scratches in the package material and that the seals are intact or other damage that would compromise the sterility of the wipers.
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| Does Berkshire offer a wiper that meets Federal Specification A-A-50177? |
| Lensx® 90 meets
A-A-50177, Type 1, Class 1 for Light Weight Lens Paper.
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| What is the difference between bulk and stacked wipers? |
| Bulk Packaging:
Bulk packaged product is placed into a bag with a cursory inspection. The sheet count is
arrived at by weight. There is 0% difference in performance between a bulk packed and stacked packed product. There is however a significant cost savings in a bulk wiper.
Stacked product:
Each wiper is inspected and stacked one on top of the other. The end result
is a square pack that when opened one wiper at a time can be removed from
the stack.
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What products can be autoclaved for use in an aseptic environment? How does autoclaving effect the wiping substrate? |
| Most wipers can be autoclaved with little change to the appearance or parameters of the wipers. Some of the non-woven wipers will show some puckering of the wiper surface. And some wipers will show slight increases in particle generation. Although bond paper may experience slight surface puckering, it is not recommended to autoclave the spiral notebooks. |
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| What is sterile vs gamma irradiated? |
| Sterile refers to a product that is validated sterile. ANSI/AAMI/ISO
procedures have been followed for verification of irradiation dose with
quarterly audits being performed to monitor bioburden levels and dose. The
Sterility Assurance Level (SAL) can be determined and is 10 -6 (which is the
chance of 1 non-sterile unit in 1,000,000) Gamma Irradiated refers to a
product that has been irradiated at some predetermined dose which is felt to
kill the bioburden. Sterility testing is not usually performed nor quarterly
audits for continued validation. The SAL cannot be predicted. |
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| What product won't scratch sensitive surfaces? |
| Lensx® 90 and MicroFirst® LP are recommended for wiping/cleaning sensitive surfaces. Wipers with high levels of wood pulp are not recommended. |
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| Can the SatPax® canister be autoclaved. |
| The canister is made of HDPE(high density polyethylene) and therefore cannot be autoclaved. It can however be gamma irradiated and we would recommend 25kGy as a minimum dose. |
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| What wiper is right for my class of cleanroom? |
| Here are some recommendations that we can suggest, but in the end, your process will determine the appropriate wiper. |
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Product |
ISO Class 3 |
ISO Class 4 |
ISO Class 5 |
ISO Class 6 |
ISO Class 7 |
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Class 10 |
Class 100 |
Class 1,000 |
Class 10,000 |
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