Aseptic Processing: A Primer - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Aseptic Processing: A Primer
PharmTech speaks to Ray O'Connor from the National Institute for Bioprocessing Research and Training (NIBRT) for an overview of aseptic processing.

Pharmaceutical Technology Europe


Environmental monitoring

Q PTE: What sort of environmental monitoring program need to be used in aseptic processing?

O'Connor: The goal of an environmental monitoring program is to provide meaningful information on the quality of the aseptic processing. Typical controls are for airborne particles and nonviable contaminant monitoring (i.e., to analyse the amount of microbes in the room). Viable contaminant monitoring of surfaces involves touching surfaces with agar plates. Viable monitoring of personnel and temperature–humidity monitoring are also typical controls to have in place.

Environmental monitoring must be done across all processing shifts (i.e., day and night). All floors, walls and equipment surfaces need to be tested. The location of the surfaces to be sampled, and the timing and frequency of the sampling, should be specified in writing, so that it is not just a random process, but rather, a risk-based process. It's also important for staff to ensure reproducible results.

The heating and ventilation and air conditioning (HVAC) unit should be under control of the building management system. This system controls the amount of air coming in to the cleanrooms and the differential pressure across the HEPA filters. If any changes are observed, actions and alerts should be raised to start an investigation and corrective–preventive action plan.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
22%
Attracting a skilled workforce
30%
Obtaining/maintaining adequate financing
11%
Regulatory compliance
37%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology Europe,
Click here