GMPPENS | cGMP Compliant Indelible Ink

There has been quite a bit of buzz surrounding GMP pens lately. Companies are looking for a way to easily identify and use pens that are GMP compliant. This saves time and money by reducing the amount of exception reports caused by improper documentation techniques. Kymanox offers a solution... GMPPENS!



One concern that comes up regularly is indelible ink and the resistance to alcohol especially 70% IPA. The rest of the industry shares this concern and frustration. GMPPENS are in fact cGMP compliant indelible ink as prescribed by the FDA. However, most alcohols (including 70% IPA) will smear "indelible ink" to some degree. It is highly recommended that companies approach the handling of the documents and use of the pens through training and awareness to reduce the exposure of 70% IPA to documents.

GMPPENS allow users in GMP environments to clearly identify and avoid using pencils, gel pens, erasable pens, etc. GMPPENS may be wiped down with 70% IPA for cleanroom and BSC use but the ink is subject to smearing with higher concentrations alcohol.

Please feel free to contact me with any questions or concerns regarding this issue. For additional information and ordering please visit http://www.gmppens.com/.




Best regards,

Justin Pawlik