Help with conforming to new GMP Annexe 1 Guidelines. A new high grade sterile alcohol wipe is launched
The recent update to GMP Annexe 1 now requires continual air monitoring over all critical processes in Grade A and B cleanrooms. This involves the use of particle counters, which are often set off by atmospheric alcohol. An alcohol impregnated wipe removes the need to spray alcohol and significantly reduces airborne particles that might be detected.
The new Klerwipe 70/30 IPA impregnated wipe is manufactured from high quality, 138 gsm pre-laundered 100% polyester with ultrasonically sealed edges. The IPA is blended with EP quality Water for Injection. The laundered wipe material significantly reduces the bioburden, enabling a guaranteed endotoxin level of less than 1EU per wipe.
The alcohol evaporates completely from the surface and the wipes do not contain any chemical binders, so no undesirable residues remain. This makes the wipes particularly suitable for use on direct product contact surfaces, where residues and endotoxins are unacceptable.
Each pouch contains 10 wipes so there is no wastage at the end of a manufacturing session. The polythene packaging features “Klertear” which makes it easy to open even when wearing gloves. The pouch is easily resealable to prevent the wipes drying out and the pouch itself does not generate any particles.
© Shield Medicare 2008