Multivac Inc. (Kansas City, MO)
For pharmaceutical and medical device manufacturers, process validation is required under the Good Manufacturing Practices (GMP) regulations 21 CFR Parts 210 and 211 and 21 CFR Part 820, respectively. Within the regulations, there are several areas of manufacturing that process engineers must address to comply with these standards. Validating packaging machinery processes is crucial for compliance.
Because current standards provide only a framework, it behooves companies to employ equipment with a validation package that surpasses these guidelines. Packaging process validation refers to the documented evidence that certifies the machine has been designed to perform a repeatable process. It also defines the machine’s reactions under a variety of different circumstances.
By selecting machinery that offers a comprehensive validation package, process engineers can streamline the installation process, ensure package quality, and sustain manufacturing best practices for the life of the system. Following are a few items to consider when selecting a validation package for a new packaging process.
THIRD-PARTY CERTIFICATION
It is extremely important to work with suppliers that are able to produce machinery that is certified by third parties. These certifications often represent a higher standard of quality and can help to ensure best manufacturing practices. The following certifications apply to all types of packaging machinery:
• ISO (International Organization for Standardization) 9000-14000.
• CE Standards.
• GS Standards.
• UL Approval.
• CSA Approval.
• TUV.
Certificates with expiration dates and brief descriptions of these standards should be included in the documentation portion of the validation package. The types of certifications that are most appropriate depend on the application, so it is imperative to address this issue in the initial stages of selecting your packaging machinery supplier.
EQUIPMENT COMPONENT VALIDATION
Validation of packaging machinery components is another step toward ensuring that quality packages will be produced on a repeatable basis. Documentation can be provided on all components of a packaging system, including the machine’s software installation and handling, operating systems, error testing logs, temperature controls, tolerances of sensors, and electrical standards. The features on packaging machinery that should be validated depend on the application and the system. Working closely with your packaging machinery manufacturer to validate the appropriate components is a key element for quality assurance and FDA compliance.
CALIBRATION DOCUMENTATION
All new packaging machines need to be calibrated before they are incorporated into a production line. As specified by FDA, packaging machinery manufacturers may not calibrate a machine for a customer. There are companies that will calibrate your system, but this task is often given to the process or packaging engineer. Therefore, partnering with a packaging machinery manufacturer that provides comprehensive instructions for calibrating the machine can greatly expedite installation.
Generally, instructions should consist of a step-by-step process for retooling critical application components and a list of instruments that were used during the factory’s calibration process. Each instrument must identify the model and serial number, and a certificate of instrumentation must be supplied that includes dates and application-specific tips for streamlining the process. These documents are also necessary for maintenance, as they allow technicians to quickly troubleshoot any machine-calibration issues that may occur throughout the life of the system.
QUALITY CONTROL SAFEGUARDS
Quality control safeguards refer to the machine’s ability to track the quality of a package as it moves through the equipment and to generate a predetermined response should it be compromised. For instance, the machine could mark the package by printing error on the top, or it could shut down entirely. With an automated system, the machine could put the package into a reject bin to ensure that it is not distributed. These responses can be determined by the customer and are outlined in the machine’s validation package documentation.
The quality process differs from system to system. For automated packaging machinery, many manufacturers have incorporated sensors into its systems to ensure that all the machine’s components are consistently operating within predetermined, acceptable ranges. Types of automated systems that use sensors include tray sealers, rollstock machines, or any other piece of equipment that can be configured with an autoloader or autopacker. Some of the functions these sensors regulate are:
• Forming and sealing pressures.
• Clean separation of two packages by the knife.
• Security of the contents within the package.
• Bar code accuracy.
Machines that offer these sensors receive documentation that certifies that the sensors are working properly.
The process for ensuring package quality on chamber machines differs from that of automated systems. Validation of the seal bar is critical with chamber systems. The performance of a seal bar influences the seal time, pressure, and temperature. However, confirming temperature accuracy can be the most-challenging task.
CONCLUSION
There are several components of a packaging machine’s validation package that can help pharmaceutical and medical companies ensure compliance and expedite installation. Identifying packaging machinery manufacturers that have established validation programs, yet offer the expertise to customize a machine to your specific business needs, will help to ensure manufacturing best practices.
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