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Figure 1: A portion of the VHP Decontamination System at STERIS before shipment. Shown are the accessory skid (left) and the generator (right).

Figure 2: Two VHP generators and skids installed in the mechanical space. A 50-gallon drum of peroxide can be seen in the foreground. The manifold that delivers VHP to the different cleanroom suites can be seen top center (white).

Figure 3: A View of the manifold. It contains pneumatic butterfly valves and insulated CPVC piping. Only one of the outlets is connected. This can serve two cleanroom suites, one at a time.

Figure 6: Air sampling results from the incomplete VHP cycle before (red) and after (blue). The cycle only achieved about 140 ppm. Fan filter units were run during the cycle. Significant reductions in airborne viables Fwere achieved.

Figure 7: Surface sampling results from incomplete VHP cycle before (red) and after (blue).

Figure 8: Air sampling results from completed VHP cycle before (blue) and after (orange). Room 223J-SAS-2 did not have a port and the door was closed. In rooms 223A-SAS1 and 223G-SAD-1, it may be useful to activate the FFUs briefly during peak concentration to determine if this reduces airborne viables.

Figure 9: Surface sampling results from completed VHP cycle before (blue) and after (orange).

Table 1: Recommended cycle for the testing environment. These are the approximate values used in the first cycle development run for the zone.

Figure 11: The room with the concentration sensor achieve about 600 ppm in 12 minutes. The injection
rate was reduced several times until it stabilized. The short increase in concentration prior to the large peak was an attempted run that was aborted by the BAS.

29.03.2021

A Case Study Examining the Benefits and Challenges of Integrating VHP® Biodecontamination into a High-Volume Compounding Facility

Nephron Pharmaceutical Compounding Facility Integrates STERIS VHP Biodecontamination System

Background

Nephron is a rapidly growing manufacturer of generic respiratory medications and a contract manufacturer of blow-fill-seal products. Also, as a 503B compounder, Nephron has made significant investments in the production of high-volume pharmaceutical preparations for interstate distribution…

11.08.2015

Bringing Cleanrooms Online, Initially and After a Worst Case Event

Introduction

Environmental control of classified areas within a biopharmaceutical facility is maintained by systems controlling humidity, air temperature, air exchanges, filtration and pressure differentials and by practices such as room cleaning, limited access and facility flow. When any of these…

20.03.2015

Use of the CDC Biofilm Reactor to Test Cleaning and Disinfection on Rouged Stainless Steel

Introduction

In process systems, as in nature, microorganisms rarely exist as single cells or even as pure cultures. Rather they exist as monoculture or mixed culture aggregates of different microorganisms. Microorganisms within a biofilm, such as Pseudomonas species, are commonly encased in a sli…

STERIS Corporation 7405 Page Avenue, St. Louis MO 63133 USA.

20.01.2015

A roadmap for regulatory compliance.

Disinfectant Validation

The U.S. FDA (United States Food and Drug Administration), MHRA (Medicines and Healthcare products Regulatory Agency), HPRA (Health Products Regulatory Authority) and CFDA (China Food and Drug Administration), amongst others, routinely make observations about disinfectant validation studies and disi…

13.01.2015

Bewährte Methoden und Verfahren für bessere Reinigungsvalidierung, Konformität und Qualitätskontrolle

Aktuelle Themen der Reinigungsvalidierung

Reinigung und Reinigungsvalidierung sind Schlüsselkomponenten der GMP-Herstellung. STERIS Life Sciences bietet eine Reihe von Ein-Tages-Seminaren „Aktuelle Themen zu Reinigung und Reinigungsvalidierung" in Europa an, die veranschaulichen, wie die Prinzipien der FDA Guidance in Prozessvalidierung…

A. brasiliensis-Sporen (1000fach) / A. brasiliensis spores (1000x

24.11.2014

Industry Best Practices for Disinfectant Effectiveness Testing

Abstract

Disinfectants and sporicides are critical for microbial contamination control within the pharmaceutical, biotechnology, and medical device industries. GMP manufacturing facilities are expected to demonstrate that the biocides used in controlled environments are efficacious against the facili…

Abb. 1: Aussehen von Rückständen auf typischen Oberflächen in Reinräumen (aus einer Entfernung von ca. 1,2 m); 3 Anwendungen mit 0,5 ml/Probestreifen. Obere Reihe: Phenol mit niedrigem pH-Wert bei 1:256; mittlere Reihe: Phenol mit hohem pH-Wert bei 1:128; untere Reihe: gebrauchsfertiges Sporizid (Mischung aus Peressigsäure und Wasserstoffperoxid). Die Teststreifen des Vinyls in der unteren Reihe und des Epoxids in der mittleren Reihe sind vergrößert dargestellt (Entfernung von 0,3 m).

Tabelle 2: Prozentualer Anteil von Rückständen* auf Edelstahl-Probestreifen nach dem Einsatz von Reinigern mit vier unterschiedlichen Entfernungstechniken. (*~43 mg/Probestreifen bei Phenolrückstand mit niedrigem pH-Wert, was 25 Anwendungen à 0,5 ml entspricht.)

Fig. 1: Appearance of residue on typical cleanroom surfaces (distance of approximately 1.2m); 3 applications of 0.5 mL per coupon. Top row: low pH phenolic at 1:256; middle row: high pH phenolic at 1:128; bottom row: ready-to-use sporicide (blend of peracetic acid and hydrogen peroxide). The bottom row vinyl and center row epoxy coupons are enlarged (distance of approximately 0.3 m).

Table 2: Percent residue* remaining on stainless steel coupons after use of cleaners with four different removal techniques. (*~43 mg per coupon of low pH phenolic residue, representing 25 applications of 0.5 mL )

22.10.2014

Fungal Spores and Disinfectant Residue Control Measures

Contamination Control in Cleanrooms

Spore forming organisms, bacterial endospores such as Bacillus species and fungal spores, such as from Aspergillus species, can present considerable challenges to cleanroom microbial control programs. While everyone recognizes that bacterial endospores are the most resistant forms, not everyone reco…

Bild 1: Wand mit Wasserschäden und Schimmelbefall (Foto: Jim Polarine) / Image 1: Water damaged wall covered with mold. (photo by Jim Polarine)

Bild 2: Biofilmbildung in Rohren (Foto: MSU) / Image 2: Biofilm formation in pipes. (photo courtesy MSU)

Bild 3 (Desinfektionsmittelrückstände auf Epoxidharzboden) / Image 3 (disinfectant residue on epoxy flooring)

Bild 4 (Desinfektionsmittelrückstände auf Vinylboden) / Image 4 (disinfectant residue on vinyl flooring)

12.09.2014

Prevention of microbial contamination in pharmaceutical and biotech manufacturing areas: a holistic approach to establishing robust control measures.

A recent best seller1 tackled the question of why an entire nation can be compelled to help one or a few people in life-threatening situations (e.g. Chilean miners), but will do little to help millions who are at equal or greater risk (e.g. Tsunami victims). This may be irrational, but is also an ac…

Fig. 1: Appearance of residue on typical cleanroom surfaces (distance of 4 feet); 3 applications of 0.5 mL per coupon. Top row: low pH phenolic at 1:256; middle row: high pH phenolic at 1:128; bottom row: ready-to-use sporicide (blend of peracetic acid and hydrogen peroxide). The bottom row vinyl and center row epoxy coupons are enlarged (distance of 1 foot).

Table 1: Percent residue* remaining on stainless steel coupons after use of cleaners with four removal techniques

02.07.2014

Fungal Spore Contamination Control and Residue Removal in Cleanrooms

Residues

Disinfectants and sporicidesare critical for microbial contamination control within pharmaceutical, biotechnology, and medical device industries. However, their regular repeated use can result in build-up on disinfected surfaces over time. These residues are potentially problematic from visu…

Abb. 1 Aussehen von Rückständen auf typischen Oberflächen in Reinräumen (aus einer Entfernung von 4 Fuß [1,2 m]); 3 Anwendungen mit 0,5 ml/Probestreifen. Obere Reihe: Phenol mit niedrigem pH-Wert bei 1:256; mittlere Reihe: Phenol mit hohem pH-Wert bei 1:128; untere Reihe: gebrauchsfertiges Sporizid (Mischung aus Peressigsäure und Wasserstoffperoxid). Die Teststreifen des Vinyls in der unteren Reihe und des Epoxids in der mittleren Reihe sind vergrößert dargestellt (Entfernung von 1 Fuß [0,3 m]).

Tabelle 1. Prozentualer Anteil von Rückständen* auf Edelstahl- Probestreifen nach dem Einsatz von Reinigern mit vier Entfernungstechniken

25.06.2014

Kontrolle von Pilzsporenbefall und Entfernung von Rückständen in Reinräumen

Rückstände

Desinfektionsmittel und Sporizide sind bei der Kontrolle mikrobieller Kontaminationen in der pharmazeutischen, biotechnologischen und Medizingeräteindustrie unabdingbar. Die regelmäßig wiederholte Anwendung kann jedoch im Laufe der Zeit zu Ablagerungen auf desinfizierten Oberflächen füh…

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