SubscribeSkan AG, have been working for many years in the field of isolator technology.
Our own research and development department is focussing on isolator design improvement, especially in the field of H2O2 decontamination, our decontamination unit SIS 700, the cycle development and qualification strategy as well as on the standardisation of biological indicators. Further we do have very close co-operation with our customers to solve their complex problems. On this basis we have done studies to answer questions about material effects, inactivation of viruses and many other subjects.
Out of this work, we gained a huge know how in this field which is extraordinary for an isolator manufacturer. Many of this studies have also been presented in seminars or published in scientific papers.
In year 2000 we published an article in the PDAjournal titled "Development and Quantification of H2O2 Decontamination Cycles"that was of great interest among specialist in this field. Some weeks ago, Mr. Richard L. Friedman, CSO, cder, FDAsent us a letter, mentioning his favorable comments about this paper as follows:
Comment FDA
"Just wanted to write to compliment you on an excellent paper in July/August, 2000, PDAJournal. Your discussions was particularly useful with regard to discussions of fraction negative methods as a cycle development tool that supports subsequent process validation efforts, using worst-case D-value in estimating the length of the decontamination cycle, and noting doubling the cycle does not solve all problems. You have done a good job of capturing the nuances of studies done with fraction negative methods in a properly balanced and science-based paper".
Furthermore the question about materials influencing the decontamination success, gained more and more importance in the mind of users and authorities. Together with Novartis Pharma AG we have performed a huge study about this topic. Also this study titled "Effect of Carrier Materials on the Resistance of Spores of Bacillus Stearothermophilus to gaseous Hydrogen Peroxide" has been accepted for publication by the PDA-board a few days ago.
After the presentation of this study to the working group of the "Pharmaceutical Inspection Convention", PIC/S, they modified their recommendation concerning inspections of aseptic isolators in the question of material influencing decontamination effect as follows:
Recommendation of PIC/S:
"The carrier type e.g. plastic, paper, metal or other, of the biological indicator organism should be relevant to the materials being gassed or shown to be irrelevant."
Since April 2002, the recommendation has been extended due to the results of our study:
"If studies have been carried to show that lethality on carrier type ais similar to materials c, d, e, etc. with a similar sporicidal process, this would mean that in house studies need not to be carried out. The data would need to be from a reputable source."
This know how has a direct impact into the design of our isolator systems. Up to now we have successfully qualified more than 40 isolator systems based on our methodology to develop decontamination cycles. Our studies answer critical questions of authorities already up front without additional qualification work required by our customers.
Out of this competence at Skan, we are able to build isolator systems of different types and sizes, all with constant, reproducible processes (see table 1), that can be qualified fast and easy, at low price with a high acceptance level versus authorities.
| Table 1, System D-value of different Skan AG Isolators Systems | Reference Isolator Skan AG, 1.4 m3 D-value [min] | Sterility Test Isolator Skan AG, 2.2 m3 D-value [min] | H2O2 Material Pass Through Skan AG, 15.0 m3 D-value [min] | Filling Line Isolator Skan AG, 9.0 m3 D- value [min] |
| B. stearothermophilus on glass carrier | 1.45 ±0.07 | 1.41 ±0.04 | 0.96 ±0.05 | 1.18 ±0.20 |
| Biological indicator commercially available | 2.28 ±0.06 | 2.22 ±0.06 | 1.62 ±0.08 | 1.72 ±0.07 |
| B. stearothermophilus on POM carrier | 4.33 ±0.20 | 4.00 ±0.30 | 3.38 ±0.16 | 3.41 ±0.23 |
If you have any questions about this topic, we would be very pleased to offer our support. Contact address:
Volker Sigwarth, Skan AG
Tel: +41 61 485 44 44
Email: Volker.sigwarth@skan.ch