PPE certified cleanroom clothing
The IsoClean products provide protection against toxic agents in cleanrooms.
Cleanroom clothing Tyvek IsoClean
Protective clothing for handling toxic agents in cleanrooms ISO class 4/5 or GMP class B
Cleanroom clothing versus protective clothing
Conventional reusable cleanroom clothing usually offers good protection against particles. In many clean rooms (e.g., the semiconductor industry), this is often enough.
When dealing with toxic agents in cleanrooms (for example in the cytostatics production in the pharmacy) the pure product protection is not sufficient. Here is a personal protection required by law.
Because many disposable protective coveralls did not meet the requirements of the cleanroom class in the past, partial solutions were used.
Reusable overalls with different coatings should at least offer a "beading effect" - even if permeation data were not available or only with a new product. But how good is the "protection" after 5 or 10 washing cycles? This would be one of the first questions of a certification body for a type examination.
Or you use certified protective arm sleeves or aprons as an additional barrier above the cleanroom clothing - and protects at least the most exposed areas.
Both solutions are more likely to be seen as emergency solutions because they question the defined by legal protection of the employee.
European legislation for the protection of employees:
According to the well-known PPE Directive 89/686 / EEC and its successor to the PPE regulation 2016/425 from March of this year, only tested and certified PPE of the highest category III may be used in handling toxic agents (including CMR drugs such as cytostatics) (L81 / 74ff). In the past, the PPE guideline had to be transposed first into national law, now European regulations are binding upon entry into force.
At the same time, the individual protective clothing components were cleaned after production under controlled conditions, especially for use in cleanrooms and packed several times.
The sterilisation is carried out by means of gamma irradiation according to ISO 11137 with a reduction of 6 log steps, the corresponding sterile certificate is attached to each packaging unit.