Even if there’s no immediate need to add robotics to your operations, there likely will be soon. Developing a strategy to implement robotics and automation will allow you to introduce the technology smoothly and in a measured way.
The pharma industry is venturing further into new and improved methods of operating, such as planning for lean and linear workflows, employing flexible filling lines capable of processing multiple formats, continuous manufacturing, and increasing the use of highly potent compounds. Consequently, the need to maximize operational efficiency combined with ensuring worker safety is creating an ever-increasing demand for automation and robotics.
The applications in pharma manufacturing are vast, including aseptic roller bottle processing, multi-format aseptic filling, aseptic cytotoxic compounding, packaging, warehousing and distribution. These applications all have similar requirements for which robotics can offer an improvement over manual fulfillment.
There are four key elements for a successful implementation of this technology:
Recognize robotic and automation opportunities: In general, consider such things as redundant operations or high batch sizes, or areas demanding uniform, predictable presentation. Consider whether the technology can offer operator and product protection, and if it can improve operating and arrangement efficiency.
A particularly important measure of the applicability of robotics in your operation is how uniform your product output may be. The same is true for lot sizes. If you produce in high volumes, robotics makes more economic sense than if you make many different products in smaller quantities and lot sizes.
Prepare a game plan: The opportunity you’ve identified for introducing robotics into your operation will give you a good foundation from which to generate a User Requirement Specification (URS) in which you initiate a dialog with vendors and involve them in preparing responses to your inquiry.
Typical robotic system URS criteria will include process description, block flow diagrams and operating rates. You should be thorough in detailing how vendor product specifications are to be presented, as well as requesting any supportive sketches for implementation.
In pharma, HVAC considerations will always be essential. Be certain to obtain HVAC classification, with specifications for product and airflow protection.
You may find that the URS may be an iterative process as you continue to refine requirements based on further considerations. This part of the process can take six weeks or longer, depending on the scope of your specifications and the number of vendors participating.
Consider proof of concept studies: Rather than committing to an entire new installation from the start, it usually makes more sense to introduce robotic systems in smaller studies to ascertain the viability of the technology.
It’s during the proof of concept phase that you may make important realizations — such as whether the payloads you’re handling may be too heavy to reach the speeds at which you’ve specified systems to operate. Such realizations should lead to further refinement of the URS, or a modification of your approach to robotics overall, and can give you greater insight into the applicability of robotics in your operations.
Develop/manage design, trials, fabrication, testing and implementation: When conducting testing, it’s best to break the process into sections. There’s testing at the site of work (vendor factory), but there is also testing to be done once the system is installed. This requires a considerable review of qualifications. Has the system been installed properly? Does it perform its functions properly? Does the entire system as a whole operate properly?
You will need to group testing into different segments that follow each other logically. Take care to minimize or eliminate redundancies; testing done by the vendor may possibly be used as qualification testing on-site, which could reduce the total time required for this phase of strategy.
This portion of the process, because it is so application-dependent, can to take anywhere from six or eight months or up to two years.
There’s little doubt that robotics will be an integral part of the pharma manufacturing process in the future. The only questions are: How soon will your operation implement the technology and how difficult will the transition be?
