Basic Guidelines for Capper Machine Validation
Many of the industries that use automatic capping machines are governed by strict regulations to protect consumer health and safety. For example, an improperly sealed cap in the pharmaceutical industry can be very dangerous for patients. Similarly, a poor closure on a food or drink product can cause the product to become contaminated with pathogens. For this reason, many industries require capper machine validation standards. This ensure that the equipment being used meets certain minimum quality requirements and has controls in place to ensure that everything works smoothly.
In this post, we’ll go over a few of the aspects that are usually covered in capper machine validation.
Capper machine validation – the basics
In the paperwork that needs to be on file for capper machine validation, you will need all the basic operating information for the capping machine you are running. This includes things like the machine’s capacity for container handling, and the capacity of the cap delivery system. It will also include which type of capping machine it is. For example, a rotary capping machine or a linear capping machine. There will also need to be a record of every aspect of the capping system, including cap delivery, inspection, etc. There needs to be a system in place to detect if caps are missing or, if applicable, if the tamper evident seal is properly in place.
It will usually also include the layout and physical environment of the capping machine, and any special restrictions that might apply, such as being an explosion-protected or biohazard safe room.
Capper machine validation – process and operator
The document will have to establish some so-called “critical parameters”. This includes things like the speed the machine is run at, the production efficiency of the capping, specifications for the torque of the capping heads, etc. As for the operator, the capper machine validation will have to establish the machine’s setup parameters, such as the capper speed, turning on the inspection system, calibration (if applicable), etc. This part of the validation can also include automatic stopping of the machine, as well as what will happen in the event of a power failure and subsequent recovery.
The capper machine validation document can be quite long and involved, depending on the industry and the regulations that apply in that country. For the most accurate information, you should consult the entities responsible for regulating your industry.
If you need any information on our capping machines to help complete your capper machine validation, you can contact us directly through our website.