4901 W. Raymond Street Indianapolis, IN 46241
The EnGuard VTC is designed to provide protection for both product and personnel. Typically, the transfer carts are used to move the aseptically filled vials, with partially seated stoppers, through non-controlled areas providing a class A / class 100 environment during the transport of the products. The EnGuard VTC, which is closed and sealed, will maintain class 100 conditions during storage and transfer of the vials from the parenteral filling lines to the freeze dryer area. The 316L stainless steel interior and exterior provides cleanable surfaces that are finished to pharmaceutical cGMP standards. The interior of the cart features coved corners and surfaces that are 100% cleanable. A special membrane covering protects the HEPA filter. The vial transfer cart environment is HEPA filtered with unidirectional airflow, which can be either re-circulated or exhausted. If exhausted, the airflow passes through a HEPA filter before release. The ergonomic design and airflow pattern provides operator protection during the activity of loading and unloading of stoppered vials. Several pharmaceutical companies have been cited recently by the FDA for failure to maintain class 100 conditions within transfer carts used to transport stoppered vials. The EnGuard VTC provides unidirectional airflow across the trays. The airflow is HEPA filtered both entering and exiting the product chamber. The vial transfer cart can be configured to either re-circulate or single pass air. All configurations are modeled and smoke tested, to assure regulatory compliance.
Sincerely Packaging and Labelling
Regards,
Client Success Team (CRM),
Sincerely Packaging Labelling