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.
Positive pressure design:
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.
- 316L stainless steel product contact and exposed surfaces. The shell is 11 gauge thickness.
- Gasket material is silicone.
- One set of HEPA filters is included.
- The dual access doors include polycarbonate (Lexan) windows.
- Product Contact – 150-180 grit or better with welds ground smooth, flush and blended to match.
- Exposed – 150-180 grit or better with welds ground smooth, flush and blended to same finish.
- Non-product contact sheet metal – 150-180 grit or better with welds as laid and strip buffed.
- Non-product contact plate and tubing – 150-180 grit or better with welds as laid and strip buffed.
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.
Regulatory Codes and Standards:
ICS equipment conforms to all applicable sections of the latest edition of the following codes and standards in effect at the date of order.
- cGMP - All equipment is designed and constructed to be in full compliance with FDA current and known proposed Good Manufacturing Practices (GMP) cGMP/FDA – Current Good Manufacturing Practices of the Food and Drug Administration, United States Department of Health and Human Services - (CFR Title 21, parts 210 and 211)
- NEC – National Electric Code
- NEMA – National Electrical Manufacturers Association
- AGS – American Glovebox Society
- ASME – American Society of Mechanical Engineers
- ASTM – American Society for Testing and Materials