GMP Vial Filling

GMP Vial Filling Achieves Compliance Easily

Counting is an important application that should not be underestimated, particularly in a GMP clean room. A counting mistake can lead to a failed audit or a recall of an entire batch for recounting. Discover more about what counts when designing a system for vial counting.

When filling vials in a GMP clean room, counting and documenting how many vials enter empty and how many leave filled is important.

As vials are filled, statistical quality control (SQC) ensures that the right volume of pharmaceutical preparation is dispensed to each vial. A problem may occur when the count of incoming empty vials does not correspond to the outgoing count of filled vials. Discovering a counting mistake too late may cause a major recall to unpack and recount the whole batch. Manual operations can often be the source of a mistake.

A popular solution is to use counting scales to accurately and quickly record how many vials enter and leave. In choosing such a weighing system, the main focus is often on its hygienic capability. But what really counts in such a situation? The weighing capacity of the scale and its accuracy are extremely important. More important, though, is the ability to determine the average sample weight of a vial. It is a complex problem that needs professional attention. Find detailed information about how to optimize counting and choose the appropriate equipment:

To select the correct weighing solution according to the right capacity, the right accuracy and the right minimum weight:

Read more about the minimum weight:

Unfortunately, many users fail to recognize the complexity of choosing a weighing solution and opt for the wrong scale. This can result in counting errors and problems during audits. For instance, when counting large lots of very small objects, it might be necessary to use a two-scale system.

1. Reference scale: a small capacity and high accuracy scale for determining the average sample weight of the vial.
2. Counting scale: a scale with the appropriate capacity and accuracy to weigh the lot of vials entering/leaving the room.

Choosing the right weighing or counting system is not only dependent on the weighing task. Often other requirements influence the selection to ensure that the weighing system meets more than just weighing needs. The capabilities of modern scale systems offer a full range of possibilities, including:

• High level of ingress protection (up to IP69k)
• Hazardous areas approvals
• Integration of a barcode scanner and a local label printer
• Communication to ERP
• SQC functionality

Discover the unlimited range of possibilities offered by the combination of high-resolution scales of METTLER TOLEDO’s PFK and weighing terminals of the 4-series with embedded counting or SQC software.