Operating a sterile pharmaceutical manufacturing facility requires a valid system and an appropriate level of environmental cleanliness to minimize the risk of particulate or microbial contamination to the product or materials being handled.
Cleanroom contamination control is especially important for the aseptic fill-finish process, which can lead to yield loss, slowed production and possible reputation damage.
We are ready to support our pharmaceutical manufacturing customers through the entire cleanroom lifecycle and provide comprehensive solutions to show how effective contamination control can improve your business.
|Food and Beverage |
Food safety and quality can be compromised by microbiological contamination from a variety of pathogenic and spoilage microorganisms present in the production environment.
Since microbial contamination can occur at any stage of the food chain, the processing environment must be considered as a possible serious source of contamination, either due to ineffective cleaning and disinfection procedures or due to contamination during production.
We bring solutions to support our customers in the food and beverage industry, achieving safer processes and increasing productivity and sustainability, while helping ensure regulatory compliance.
The cosmetic industry can especially benefit from environmental control and monitoring of process conditions. This is especially important because moisture can promote bacteria and mold growth, particularly in liquid skincare and makeup.
Mold contamination of natural beauty products must be held to even higher standards because the lack of preservatives makes the product more susceptible to environmental damage.
In today’s challenging regulatory environment, most cosmetic manufactures must undertake a series of upgrades to improve their quality system, production process and product release testing.
To make skincare more effective and avoid any serious safety issues, as well as to protect your companies reputation, a knowledgeable partner focused on delivering solutions that meet the highest safety and quality standards is needed.
|Medical Devices |
The safety of medical devices for patients is the full responsibility of the manufacturer. Cleanroom and controlled environments play a key role in medical device manufacturing.
While the primary focus of the guidance is on cGMPs in 21 CFR 210 and 211, considerable attention has been given to environmental control. USP <1116> (“Microbiological Evaluation of Clean Rooms and Other Controlled Environments”) also offers device manufacturers guidance that can be used as a framework for development of their environmental monitoring plans.
As an experienced solution provider, we will offer services covering the full range of requirements for effective environmental monitoring and help you get the products you need, to meet stringent contamination control demands for any grade cleanroom at your various sites.
A new revision of the EU GMP Annex 1 was released by the European Commission in August of 2022. This long-awaited revision replaces that released in 2008 and comes two years after the release of the most recent draft version of the document.
A Pfizer case study published in July 2018 by José-Miguel Montenegro-Alvarado, et. al. highlights the benefits provided by rapid microbial methods in evaluating risks and expediting recovery after a hurricane.
The Process and Environmental Monitoring Methods (PEMM) Working Group is a collaboration of members from industry and instrument manufacturers that work together to support the use and acceptance of bio-fluorescent particle counting (BFPC) modern microbial methods within the pharmaceutical, personal care and food and beverage industries.