Offline testing integrated from the beginning can eliminate weeks of unnecessary downtime
Though not an afterthought by any means, validation seldom is integrated into every phase of serialization project planning, particularly the early stages, when the project’s scope and objectives are being defined.
The validation phase for pharmaceutical manufacturing automation projects often is initiated very late in the project — often after the Factory Acceptance Test has occurred. Engineers who have implemented automation solutions are comfortable with instituting their own processes and have a general working knowledge of line automation. They know what to expect at the end of the process, and plan the validation phase according to what they’ve encountered in past projects.
In the case of serialization, however, relying on this mode of operation often results in the startup and validation team facing unanticipated problems at the end of the project, leaving them to configure solutions on the fly. Unlike previous production line projects, serialization projects have a significant IT component. The type and level of IT integration required to facilitate serialization introduces a variety of potential problems that engineers haven’t encountered previously. Resolving them while installing a serialization solution is a blueprint for extended downtime, increased stress, and significant project cost overruns.
A new way to think about and approach testing and validation can save pharmaceutical companies time and money. Built around the idea of “onsite but offline” testing, this work flow gives engineers and validation personnel the flexibility to address problems with serialization implementations. Integrated into serialization projects right from the beginning, offline testing can eliminate weeks of unnecessary downtime from these implementations.
The Serialization Imperative
The Drug Supply Chain Security Act (DSCSA) mandates that manufacturers begin serializing all prescription drug products for the U.S. market at the saleable unit (bottle, carton, tray) and homogenized case level starting in November 2017.
This system will enhance the U.S. Food and Drug Administration’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.
To the uninitiated, serialization appears to be the straightforward process of printing an identifying number on products and shipping cases — similar to the lot and date code that are currently applied to each product.
In serialization, however, it’s not the complexity of the production line procedure that hides potential problems. The true issue lies in the integration with the serialization numbering systems outside the production line (often called “Level 4” systems as shorthand for their place in the hierarchy of IT solutions) as well as the myriad quality control procedures required to maintain the integrity of the numbers.
Integrating the production line with Level 4 data makes it subject to every quirk and blip that can occur on the corporate network, each of which can potentially shut down the serialization system and the production line.
Further, the QC team can no longer simply remove an item from the line for testing — serialization protocols require additional processes to allow for any sampling or disposal of products once the number has been applied. All of these elements combine to require extensive testing and validation to yield a fully operational production line.
Low-Impact Validation Model
So what is the solution to this potentially costly mode of operation? The great news is it’s not all that hard to avoid prolonged production shutdowns while validating serialization solutions. A long-known but often-ignored best practice does the trick: onsite but offline testing and validation.
Ideally, the new serialization solution is set up behind the same firewall as the target packaging line. It typically consists of equipment similar to what’s existing on the floor — perhaps spares or older versions that are kept in reserve, or packaging lines not currently in use. Purchasing used equipment is also feasible. The shorter production line downtime as a result of this method may often justify the cost of the surplus equipment.
By setting up this “simulated” packaging line, startup and validation teams can do what they do best — Site Acceptance Testing (SAT), Installation Qualification (IQ), and parts of Operational Qualification (OQ) — all while the targeted production continues uninterrupted.
This environment also addresses a major shortcoming of the Factory Acceptance Tests (FAT) that serialization vendors sometimes provide. Those tests are designed to validate the performance of individual components, but not their performance in an integrated solution. Perhaps the most important benefit derived from this is it gives start-up and validation teams a risk-free environment for testing and validating IT (Level 4) connections.
Employing an onsite but offline testing method has been proven to cut weeks of downtime from a potentially lengthy start-up and validation phase, even if the validation team doesn’t truly execute any of the protocols offline. Setting up cameras and printers, testing failure, rejection and recovery modes, and loading software to ensure connectivity with Level 4 systems helps minimize problems that could keep a packaging line down for days, if not weeks.
Planning onsite but offline testing into the serialization project from its inception is critical. This gives the operations and validation teams a forum to plan what to build, and predict implemented functionalities. It also enables the company to see, at a strategic level, whether there are economies to be had outside the immediate scope of the project.
For example, if a company is required to serialize several production lines, it should apply standards to as many of the specifications as possible. The opportunity here is to not only reduce engineering costs, but also costs for training, documentation, validation and post-implementation maintenance, while also simplifying standard operating procedures.
Manufacturers that adopt this testing and validation strategy, even those who are late to start their serialization programs, give themselves a better chance to be in compliance by November 27, 2017 than those who don’t. They will also enjoy shorter downtimes and less cost of ownership, while helping ensure a safer prescription supply chain for all — which is really what it’s all about.