According to the CGMPs, each manifold filling sequence, each uninterrupted filling sequence, every cryogenic vessel filled, and each storage tank following a delivery is considered a new lot and is required to be assigned a new lot number.

For firms filling liquid oxygen for delivery to home patients, each of the large cryogenic vessels or dewars either portable or permanently mounted in a van or a truck are required to be assigned a unique lot number.

The assigning of a single lot number for an entire day's production is not acceptable.  A manufacturing operation, such as the filling of high pressure cylinders on a multi-outlet manifold, is governed by a set of manufacturing procedures or conditions. When these procedures are performed from the beginning to the end of a process they provide assurance that the batch is uniform and consistent.  As such, each batch is in itself a separate entity with its filling operations unique to that filling sequence.

At the present time, cryogenic home vessels filled at a patient’s home, i.e., curbside are not required to bear a lot number.  However, cryogenic home vessels filled on site and stored for future delivery, or cryogenic home vessels filled by a third party, require lot numbers.

Click here to see Applied's lot stickers.