Bio-Decontamination

Isolators are purpose-built, critically controlled manufacturing spaces for a range of processes within the pharmaceutical manufacturing and pharmaceutical drug compounding industries. To comply with the new EU GMP Annex 1, both open and closed isolator systems require decontamination of the isolator between manufacturing campaigns. Our experts can help you select VPHP sterilization equipment and develop and validate decontamination cycle parameters.   

Pass-through boxes and RTPs are designed for the safe transfer of materials between work areas within aseptic processing cleanrooms. These sealed boxes maintain complete environmental separation between work areas and minimize cross contamination during the transfer process. 

Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use have been updated for next year. Anyone selling/shipping these products to the EU must be in compliance with the new guidelines which can come at considerable expense. Amira has developed a product (Easypass) specifically designed for this application.

Easypass is a portable laminar flow trolley with a vH2O2 generator on-board and a fast-docking interface for cleanrooms.  It is a powerful and revolutionary system designed to simplify construction projects that may be required in older facilities to meet the new Annex 1 requirements and speed up bio decontamination during between-class material transfer. Thanks to its brilliant design, activities and time required for its installation in existing cleanrooms are simplified and reduced.

Aseptic fill-finish is the culmination point of the pharmaceutical drug manufacturing process. The success of this critical process is reliant upon procedures, equipment and controls and bears the highest risk in the entire manufacturing process. If something goes wrong here, the cost can be significant whether measured in dollars or time. At SentrySciences, we can help you monitor this critical process for microbial contamination using traditional or rapid microbial contamination methods, and we can help you with VHP sterilization equipment and sterilization protocols for use between processes or after maintenance. 

Laboratories that handle infectious agents are categorized by the Biological Safety Level (BSL) corresponding to the risk level of the pathogens being handled. BSL-3 laboratories are common throughout the world for applications ranging from microbiological research, scientific study, biosecurity, vaccine research, production facilities and biomedical, diagnostic, and clinical applications. When fitted with a Class III Biosafety Cabinet, these labs can also handle higher-risk or unknown-risk agents. With our wide range of VPHP sterilization products, our experts at SentrySciences can help you develop sterilization protocols to ensure the safety of your employees and sensitive equipment. 

The COVID-19 pandemic has been a catalyst to identification of gaps within the Emergency Services & Transportation industry, and specifically in the manner and level of bio-decontamination conducted routinely in transport vehicles. Our experts can help you simplify your sterilization protocols, while protecting your employees and the sensitive equipment inside transport vehicles. The Bioreset family of products uses V-PHP as a cold sterilization agent, and unlike other products, it is safe for sensitive equipment, electronics, furniture, and leaves no residue - so no post-cycle cleaning is necessary, saving you both time and money!