By Sonia Vroman / Ultimate Solutions Regulatory Compliance Department
In the past several decades, changes to equipment and systems have occurred in the Drug Manufacturing Industry due to new demands in Regulation. Although Regulation has had a significant impact to these changes, other requirements such as Companies Policies, production demand as well as changes in materials or components have created a need to continuously modify and/or upgrade equipment and/or systems.
Packaging processes have been impacted by these requirements in a way that have compelled significant innovation and creativity. As new or revised Regulations or requirements are introduced, the Packaging sites will ask themself the question: How can I comply or meet these requirements while minimizing the impact to the existing materials, process, systems, and/or equipment?
Purchasing a new packaging line or replacing line equipment/system/software can be costly and, depending on the application (bottle line, blister line, sachet line, etc.), packaging lines can sometimes have up to twelve pieces of major equipment arranged in sequence that perform its process. Due to the cost and complexity of replacing lines or equipment, most sites will choose to perform modifications or retrofits to existing line equipment whenever possible.
The intent has been to maintain the Packaging Process or Operation as originally designed, while introducing new devices, upgrades and/or auxiliary equipment to meet the requirement. The culture of “doing more with less” has also been translated to the use of what is “there”, instead of acquiring new versatile technology that has been designed to adapt to a changing regulated industry. Although it is difficult to predict what the future holds in terms of regulation, requirements, or technology advancement, in reality we must face that this tendency to use what is “there” as the baseline or starting point for meeting the requirement has been and will continue to be the chosen approach.
All sites evaluate these changes in terms of regulatory impact through their internal Change Control Process or in terms of equipment/system impact through their Automation Engineering/Information Technology (IT) process. But most of these evaluations only have a general or “catch all” approach that may not detect or foreseen all potential impact to the equipment/system, package quality or the overall packaging process.
In addition to the before mentioned evaluations, it is recommended to assess the proposed changes in terms of potential impact to equipment or line efficiency, equipment wear, impact to the other quality attributes and other line equipment, impact to the site personnel, etc. Some of the following strategies or approaches can be used in order to further assess these potential impacts:
- When assessing a proposed solution or upgrade, typical evaluations may include a Risk Analysis, FMEA, etc. Normally, these evaluations will be limited to the process step/equipment impacted by the change, but as a good rule of thumb, they should also include potential impacts to the subsequent steps, if applicable. In addition, these risk assessment tools can be expanded beyond evaluating the impact to Product quality or Patient Safety by including areas such as Operators Safety/Ergonomics, Maintenance and Efficiency. If it is not possible to expand the existing tool due to site requirements or templates, it is possible to create a risk analysis tool to independently assess these additional areas.
- Whenever possible consider a prototype or a simulation. This investment can ensure testing outside the line without impact to the operation. It will allow for offline debugging and improvements prior to installation or uploading to a line tied to the commercial operation process.
- Evaluate “fit for use”. Is it as fast as the current process step; can it keep up? Does it physically fit in the area intended for it, can it be easily reached for operation, maintenance, or cleaning? Does the current control system have enough memory for the upgrade? Can the utilities sustain the new auxiliary equipment? Is there enough conveyor space for the reject delays? Will it cause additional “rejections” or impact the line throughput? Is it hard to clean/maintain; how difficult will it be for the operators, mechanics, or technicians to clean, maintain or update in terms of their current knowledge and training?
- Is it cost effective short and long term? Some solutions are not initially that costly, but replacement parts, continuous wear and maintenance can make them costly over time.
- Is it versatile? Can it be used for future changes in components or materials? Can it keep up with changes in technology (upgrades)?
- Choose wisely. Is the vendor /contractor reliable? Is it proven technology, in the Site or in this Industry? How fast can the vendor or supplier provide support? How knowledgeable is the vendor/supplier in this technology, process, or requirements?
Why can we help you
Ultimate Solutions is a global leader in Validation, Regulatory Compliance, Serialization, and Industrial Automation for the Life Sciences Industries.
For the past sixteen years, Ultimate Solutions has delivered proven results in hundreds of projects and thousands of service hours to the pharmaceutical, biotechnology, medical device, and logistics markets.
Our regulatory knowledge moved us to work closely with Systech Only One as a Partner to better understand and work with the Serialization and UDI requirements of the Drug Supply Chain and Security Act (DSCSA).
We have certified Project Managers (PM’s), Project Engineers (PE’s), Field Engineers (FE’s) and Validation Engineers with extensive experience and knowledge. We offer the VIS+ Model, an innovative turnkey solution where the customer works with Ultimate Solutions as their only Serialization Integration provider including the Validation, Integration, and Serialization services.
Our Automation and Integration (https://uscglobal.com/industrial-automation/) team has a vast experience in vision system technologies, design, modifications, integrations, and equipment re-builds (retrofits). As part of the team, we have automation engineers, mechanics, programmers, and specialists which have been able to complete projects locally and globally.
For more details and information visit us at www.uscglobal.com