Material Transfer System Improves Bioburden Control

The STERIS VHP DC-A atmospheric pass-through chambers are designed for material transfer to aseptic areas in aseptic drug manufacturing and laboratory research facilities. The chambers use the STERIS VAPROX vaporized hydrogen peroxide (VHP) low-temperature surface bio-decontamination process that ensures 6-log reduction of bioburden. The pass-through chambers complement the company’s washers and steam sterilizers.

Many pharmaceutical manufacturing facilities are under pressure to improve their material transfer bioburden control. Manual wiping operations, lack of continuous control, and remaining contamination risks while transferring bags of goods from a lower grade classified area to a higher tend to create bottlenecks in many facilities, according to the company. In addition, many research facilities are using low-temperature sterilization methods to reduce bioburden on incoming materials for animal holding areas to improve animal well-being and ensure consistent research outcomes.

The chambers are independent from building heating, ventilation, and air-conditioning (HVAC) systems. The chambers also have integrated peroxide sensor monitoring, HEPA filtration, and the possibility to have particulate monitoring for the transfer process. The biodecontamination process has a newly-designed integrated catalytic aeration system that provides fast cycle times. 

The new product line complies with current GMP design and documentation requirements, current GAMP guidelines for control systems, and is fully factory tested prior to delivery. The “Electronic Data Security” options allow users to configure a comprehensive yet cost-effective system to manage vital electronic data and comply with FDA 21 Code of Federal Regulations Part 11 and European EudraLex Annex 11 requirements.

Source: Steris