Next October (15-18), the 26th edition of ISCC, the International Symposium of Contamination Control on behalf of ICCCS, International Confederation of Contamination Control Societies will be hosted in Milan by ASCCA. The event will bring together leading technology providers, end users of the different areas of use of contamination control, academic scientists, and international regulators […]
Combo, the tailor-made solution proposed by Amira for VHP bio-decontamination of complex environments with fast and effective cycles, enabled C.O.C Farmaceutici to upgrade its microbiological contamination control systems and achieve greater efficiency while limiting business interruptions. Need: Following the introduction of Annex 1, C.O.C. Farmaceutici faced the need to upgrade its facilities, including the bio-decontamination […]
Biological safety cabinets, also called biohazard hoods or BSC, are designed to protect the operator and environment from potential biological contamination. In fact, it is considered a collective protective device. Reading this article, you can find out why and when it is essential to bio-decontaminate them and why VHP technology is the winning choice among […]
IBI (Istituto Biochimico Italiano G. Lorenzini Spa), a company that has been producing and selling injectable products all over the world for 100 years, chose Easypass for flexible and innovative bio-decontamination. The new solution proposed by Amira helps simplifying bio-decontamination and material transfer from/to cleanrooms. The project: Implementing sterility control rooms on the same floor […]
VHP biodecontamination in pharma industry Vapor-phase hydrogen peroxide (V-PHP or VHP) bio-decontamination is a process of surface sterilization that has been extensively validated and used in the pharmaceutical industry for many years. In fact, VHP is one of the most commonly used sporicidal agents for bio-decontamination of cleanrooms, isolators, RABS and other controlled environments. Biodecontamination […]
Vapor-Phase Hydrogen Peroxide (VHP) is mentioned by Food & Drug Administration (FDA), Environmental Protection Agency (EPA), United States Pharmacopeia (USP) and other regulatory agencies around the world as a surface sterilization agent. During April 2023, thanks to the commitment and initiative of our distributors, visitors who attended the events mentioned below had the opportunity to […]
Demonstrating efficiency and responsibility also in its management system, in April 2023 Amira got UNI EN ISO 9001:2015 certificate. Obtaining this certificate not only represents an important milestone, but also demonstrates the company’s constant commitment to pursuing continuous improvement in the quality of its products/services with a view to full customer satisfaction. With the ISO […]
Contamination control is a crucial element in the preparation of antiblastic drugs. Constant and continuous monitoring of particulates, airborne microbial load and any environmental parameter that may influence the quality of sterile product are imperative to protect patient safety. Attending the course ‘The Future in antiblastic drug units‘ scheduled at the Simulation Center – Humanitas […]
VHP bio-decontamination, using vapor-phase hydrogen peroxide (V-PHP) as a cold sterilizing agent, allows to eliminate a broad spectrum of micro-organisms achieving 6 Log reduction (same level as sterilization) and reaching all exposed surfaces with a perfectly uniform gas distribution. What a better ally for sterile drug manufacturers who have to meet different Annex 1 requirements […]
EN 17141:2021, introduced in April 2021, defines the new standard for microbiological contamination control in cleanroom and controlled environments, introducing minimum physical and biological efficiency specifications for microbiological
