You are here:

Pharmaceuticals/Eye Drops filling validation

Advertisement


Question
Hello Dear Michael:
My company is planning to make eye drops, so i have to validate the manufacturing line. But i've never worked with plastic dropper bottles before, could you please tell me, if you know, there's any guideline or link that talk  about Media Fills in Ophtalmic Solutions.


Thank you my best regards!

Answer
Jose:

other than ensuring that the plastic bottles do not have extractables that will inhibit microbial growth (and if there are, then neutralizing them), aseptic process validation of plastic bottles is identical to glass bottles - the FDA and PDA "Guidelines on Validation of Aseptic Filling".

Pharmaceuticals

All Answers


Answers by Expert:


Ask Experts

Volunteer


Michael Anisfeld

Expertise

Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements

Experience


Past/Present Clients
UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries

©2016 About.com. All rights reserved.