According to the CGMPs, each manifold filling sequence, each uninterrupted filling sequence, each 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.

The assigning of a single lot number for an entire days production is not acceptable, you must do so by batch. 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 which when performed from the
beginning to the end of a process provides 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.

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.

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.

Lot Stickers and Equipment:

OXYMARK Lot Stickers - 750 per roll!

Blank - #1109-0002

Lot and Exp. Date - #1109-0002A

Lot and Liter - #1109-0002B

OXYMARK Label Gun  - #1109-0001

OXYMARK 4 Label Gun (Metal Body/black handle) prints two lines for use in applying the lot number and expiration date or contents to medical oxygen cylinders.

OXYMARK Replacement Ink Roller

# 1109-0002IR

For more information on our products, call 888-327-7301 or email us at info@applied-inc.com