ICS offers a custom designed Lyo Transfer Cart that is a self-contained, battery powered enclosure designed for transport of products through uncontrolled space, as required by the manufacturing process and facility layout. Most commonly, the cart is used during the lyophilizer process, but the cart can be used to transport any product for any process. Because of recent scrutiny from the FDA, US drug manufacturers are realizing that products should not be transferred through unclassified space without the protection of a transfer cart. The cart creates an ISO Class 5/IEST Class 100 environment to protect the product while being transported through unclassified areas. Since each user application is unique, the ICS transfer carts are custom designed for each application. Below are the details of a typical cart.
The system creates an environment of laminar flow air within the cart, using positive air pressure through HEPA filters and aseptic design and manufacturing principles.
The lyo transfer cart operates on 110V in loading and standby mode and then on battery power for up to two hours. This typically provides adequate time to transport the product as required by your process needs. The system includes a visual and an audible alarm for low battery condition. While plugged in, the cart continues normal operation and charges the battery.
The control panel provides operation status of the cart and monitors the pressure of the enclosure and the power (110V/battery) status of the unit. Alarms for high pressure and low pressure are included. If a low pressure event occurs, an audio and visual signal is issued; then a “keyed” reset is required.
Many customers use a particle counter as an additional monitor device to insure the integrity of the product.
The lyo transfer cart is designed and fabricated in accordance with current Good Manufacturing Practices (cGMP) established by the United States Food and Drug Administration (FDA CFR Title 21, parts 210 and 211) and general practices adopted by the Pharmaceutical, Biotech and Nutraceutical industries.
The product contact surfaces are chemically passivated to remove ferrous deposits and other parent material impurities.
ICS equipment conforms to all applicable sections of the latest edition of the following codes and standards in effect at the date of order.