The Role of Glasses in Aseptic Production: A Detail Often Ignored - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

The Role of Glasses in Aseptic Production: A Detail Often Ignored

Pharmaceutical Technology

Call for papers
With the exception of what happens to the particles included in the 0.2–1.0-μm range, with bigger particles, we did not observe a significant variation in their percentage ratio compared with the total calculation. This probably means that the physical degradation of the material in analysis, which leads to particle release, does not vary qualitatively during the autoclave cycles, although there is acceleration after the twentieth cycle.

We concluded that visors subjected to repeated autoclave cycles show an increase in particle release dependent on the number of cycles to which they are submitted. Particles of 0.2- and 0.4-μm diameters increase proportionally in greater measure; those particles that are present on the exterior surface of the sample and not incorporated in the polymer are washed away from the glasses' surface during the autoclaving.

Check of the elastic strip particle release. The treatment of elastic strips in autoclave cycles shows a remarkable increase in particle release after five autoclave cycles. The particles then settled until the end of 30 cycles of treatment. The biggest increase is that of the particles of about 0.2-μm diameter.

Figure 3 shows the percentage variation of particles of various sizes. There is an interesting absence of variation of particle composition after 30 autoclave cycles. In the 2.0–1.0 μm range, the increase in the particles released for strips follows a linear course proportionate to the number of autoclave cycles. The most important percentage is constituted by 2.0 μm-dimension particles.

The increase in the particle release from the elastic strip in the considered range is related to the number of autoclave cycles to which the strips are subjected. Based on these data, we concluded that elastic strips subjected to repeated autoclave cycles show an increase in the particles released dependent on the number of cycles to which they are submitted. Specifically, the number of 2.0-μm particles increased more than the others. Later, the number of 0.2-μm particles released decreased and the number of larger particles decreased, probably because of the second phase of material degradation.


Based on the data, the masks that are currently available have been further developed by the manufacturer, both in the frame color and in the elastic strip material, to better satisfy pharmaceutical customer' needs. These adjustments contribute to a reduction in the particles released, thus improving the masks' performance and usefulness in controlled-contamination areas.

Maurizio Battistini is the general manager of APP Pharmaceutical Partners, Switzerland, Via Cadepiano 24, CH-6917 Barbengo, Switzerland, Maurizio

Submitted: March 2, 2006\. Accepted: April 14, 2006

Keywords: aseptic processing, cleanroom, clothing systems, microbial sterilization


blog comments powered by Disqus
LCGC E-mail Newsletters

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

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
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
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,
Click here