Transfer Carts

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 from the parenteral filling lines to the freeze dryer area. Typically, the transfer carts are used to move the aseptically filled vials, with partially seated stoppers, through non-controlled areas. The EnGuard Transfer Cart, which is closed and sealed, will maintain class 100 conditions during storage and transfer of the vials.

Common Uses

The EnGuard Transfer Cart is designed to provide protection for both product and personnel. The cart provides a class A / class 100 environment during the transport of products through uncontrolled areas, such as the transport from a filling line to freeze dryer area. The 316L stainless steel interior and exterior provides cleanable surfaces that are finished to pharmaceutical standards. The interior of the cart features coved corners and surfaces that are 100% cleanable. A special membrane covering protects the HEPA filter. The EnGuard Transfer Cart environment is HEPA filtered with unidirectional airflow, which can be either recirculated 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.

Physical Requirements

EnGuard Transfer Carts are ergonomically designed for ease of transport as well as loading and unloading.

Construction

316L stainless steel is used to construct interior and exterior. The EnGuard Transfer Cart sits atop clean room type wheels. The door design can be solid, or engineered plastic for viewing the interior contents without exposing the product. A special, cleanable membrane protects the HEPA filters.

Dimensions

EnGuard Transfer Carts are built per customer size requirements. Typically, the freeze dryer tray size determines the cart's dimensions.

Air Flow

The EnGuard Transfer Cart provides unidirectional airflow across the trays. The airflow is HEPA filtered both entering and exiting the product chamber. Transfer Carts can be configured to either recirculate or single pass air. All configurations are modeled and smoke tested, to assure regulatory compliance.

Battery Power

EnGuard Transfer Carts are configured to accommodate customer requirements. A maximum of twenty-four (24) hours of operation between recharges is possible. The Transfer Cart is recharged with a standard 110V 15amp wall outlet.

Sanitization / Sterilization

The exterior of the EnGuard Transfer Cart can be manually sanitized. Manual sterilization or Vapor Phase Hydrogen Peroxide (VHP) sanitizing is used for the interior. The tray holding racks are removable for cleaning, sanitizing or steam sterilization. If they are to be steam sterilized, the rack can be configured to fit your current autoclave size.