A clean sweep — the rise of low maintenance, automated aseptic processing lines

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Richard Lewis of Biopharma Group looks at the rise of low maintenance, automated aseptic processing lines.

Contemporary procedures to ensure the cleanliness of vials, for use in aseptic processing environments appear to be at the forefront of technology more than ever before.

This may, in part, be associated with increased attention from regulatory agencies, and the drive towards compliance as a result. The presence of micro-organisms and other contaminants can have severe consequences, for example, should foreign material enter the blood stream, following administration of an injectable drug product.

Manually washing vials can be cumbersome and inefficient, with large variations in the level of cleanliness batch-to-batch and vial-to-vial; an inconsistency which poses issues during validation. Proper and thorough vial washing, depyrogenation, is therefore critical to ensure the safety of patients. The purchase of pre-sterilised containers however, can be cost prohibitive as a long-term solution.

Continuous aseptic processing

Continuous aseptic processing, therefore, has significant advantages, which is why it has fast become a recommended practice within manufacturing facilities, and a popular solution to this conundrum. In less than 30 minutes, a container can move from the vial washing machine, into the sterilisation/depyrogenation tunnel, and finally towards the filling/stoppering/capping machine — no operator intervention or re-contamination occurs during any point of the aforementioned cycle.

While it is now becoming more accepted that aseptic process equipment is the way forward, it is essential to know which to choose to achieve the best results. For instance, some devices include gears, belts, chain, grease points, to name a few, which may actually become a source of particulate generation, and ultimately, contamination; an occurrence that should always be avoided.

Industry standards, therefore, continue to seek alternative equipment designs, negating the reliance on moving parts, to minimise potential containers (i.e., glass vials) becoming compromised.

This has led to a focus on units composed principally of static parts, in some cases as few as two moving parts may need to be present:

  1. Inside the wash chamber itself
  2. The central column and the out-feed mechanism

Instruments such as those described can be used as both ‘standalone’, and integrated in to full aseptic production line.

Of course, equipment must be used in such a way that strictly adheres to any cGMP guidelines, to satisfy the strictest of process and cleaning (CIP/SIP) or software compliance (CFR 21 Part 11), too — another favourable facet of the technology.

The story does not simply begin and end at this stage though, due to the complexities associated with aseptic processing. To effectively lower risks of container contamination, companies and operators alike, seek to establish integrated processing lines.

An example of other salient techniques/mechanical devices encompassed within these ‘lines’ to curtail the possible propensity of particulate generation are outlined, below:

  • Depyrogenation tunnels
  • External vial washers
  • Rotary vial washers
  • Automated loading/unloading systems
  • Filling and capping units

These items should be carefully considered to ensure best practice within aseptic processing lines is maintained.