Meeting ICH Requirements
The objective of ICH is to increase international harmonisation of technical requirements to ensure that safe, effective, and high quality medicines are developed and registered in the most efficient and cost-effective manner.
Pharma Ointment Residue via CIP Detergent
Q. We are a generic pharmaceutical manufacturer of Creams and Ointments. We are having difficulty cleaning equipment (specifically CIP) after making these types of products. We have been successful in cleaning 95% of our products using the alkaline detergent. We have couple of products that leave a white film after the cleaning cycles. These products do not contain metal oxides. We are planning to try the Citranox acid cleaner. Any suggestions?
Residue Testing Using UV and HPLC Methods
Q. We are interested in Alconox detergent for cleaning during our production process. Since we produce several kinds of medicine, we need to be sure Alconox do not leave any residue after cleaning. We want to test the residue of Alconox by UV method or HPLC method. Could you send reference or guide on these methods.
Determining Acceptable Residue Limits
Q. How do you determine acceptable residue limits when performing a cleaning validation?
A. All Alconox Inc. cleaners have an oral LD50 of greater than 500 mg/Kg acceptable residue limit. Alconox®, Liquinox® and Citranox® all have an oral LD50 of greater than 5 g/Kg. If you calculate 1/1000 of the LD50 as a potential residue in a dose …
See You at Interphex 2016 in NYC
Join us in NY, NY on April 26-28, 2016 at INTERPHEX — the premier pharmaceutical, biotechnology, and medical device development and manufacturing show.
Come visit our booth, #2226, to receive our unique gifts, expert technical support for critical cleaning applications and detergent samples.