Even while some medical device manufacturers (MDMs) have their own in-house packaging lines and skills, many corporations outsource the packaging of their medical devices to a third-party contract packager. Small-batch sealers are very affordable, but large-volume production necessitates the purchase of expensive packing equipment, which takes up a significant quantity of precious floor space in a manufacturing plant. As a result, many businesses choose to outsource their packaging to a contract packager rather of making a huge capital investment in equipment and space. If your firm falls into this group, there are a few things you should keep in mind while working with a contract packaging company.
From food to consumer goods to medical equipment and medicines, PRO-TECH Design & Manufacturing, Inc. is utilized in a wide variety of products and applications. The medical instrument and pharmaceutical industries are governed by a particular set of laws and regulations that are intended to guarantee that their products are safe and effective, as well as sterile to the point of use where required by law. It is possible that a contract packager who routinely packages food items or consumer goods is not aware of all of the applicable rules.
As well as the standards for medical and pharmaceutical packing Many new businesses are joining the market as an effect of the present COVID-19 issue, attempting for the first time to deliver desperately must medical supplies and personal protective equipment to the public. Most of these businesses are well-intentioned and are shifting gears to assist where they are needed, but they may lack the requisite expertise or understanding to ensure that they comply with the requirements.
Quality Management System in Place
The contract packager is a vital component of your supply chain operation. As a result, you should follow your internal quality system while evaluating them as a vendor candidate. This would ordinarily entail regular audits of the services and the facility's operations (either via a paper audit or an in-person visit). Make certain that the contract packager you choose have the essential competence to adhere to all medical device packaging regulations. Verify that they are complying with all requirements by conducting an audit. Is there a quality management system in place? Is there a formalized training program in place? Is there a system in place for validating the facility and equipment? Is there evidence to suggest that their processes are under tight control? Does the company have a calibration and maintenance program in place (and is it adhering to the schedule)? Do they keep employees on staff who have the appropriate education and experience to carry out the responsibilities assigned to them?
Validations of the packaging and processing
However, while you will rely on the skills and services provided by the contract packager, you will ultimately be accountable for the packaging of your medical device. This consists of two critical components: the validation of the packaging process and the validation of the packaging. When the FDA executes an audit of your organization, they will expect you to be able to provide all of the essential documents demonstrating that both your packaging and your packaging method have been properly and completely tested. For the goals of this paper, we shall be concentrating on the verification of the packaging process. Let's accept a closer look at what this entails.
Furthermore, protective packaging is an important component of the overall package system design. The sterility of the completed device can be compromised if the protective packaging is changed or assembled incorrectly. In order for the contract packager to assemble the packaging system correctly, clear and simple instructions must be provided to him. It is necessary to verify the assembling process.
Schedules for Calibration
In addition to packaging equipment calibration and maintenance, the contract packager is also responsible for packaging equipment. To guarantee that the sealer is continuously working within the verified process parameters, for example, they should have methods and policies in place that have been developed and implemented. This would involve preventative maintenance, calibration schedules and processes, and routine quality testing of seals to verify that the seal-strength values are within the range specified by the validation method. Please request supporting documentation for these actions to be kept on file for reference.
Training
The contract packager is responsible for ensuring that their personnel receive continual training. This would entail running the packing machinery and examining the finished items when they have been completed. Before boxing, the majority of firms do some sort of quality control check. This procedure should be documented and followed as closely as possible. People responsible for inspecting must provide proof of sufficient training and skill in doing inspections in accordance with the documented inspection method before they are allowed to conduct inspections.
Controlling the Changing Environment
Is it possible to find out if the contract packager has implemented change control procedures? Changes in equipment, procedures, or supplies must be examined to see whether they will have an influence on the overall packaging system. Some modifications will necessitate the completion of extra validation tasks. Are you advised of modifications, and are the changes examined by the contract packager for their impact on the contract? You will require documentation of the modifications made and the consequences of those changes, which can be given by the contract packager or created by your organization.
Design Support that is Appropriate
Last but not most unreasonable, let us talk about design. Check to ensure that any package advised by the contract packager satisfies the specific requirements of your device before purchasing it. It is necessary for packaging to have adequate size for the product, to be sufficiently sturdy and protective in order to endure the rigors of transportation and distribution and to be built for sterilization compatibility. Despite the fact that the contract packager has recommended a certain package, you are still responsible for explaining your choice of packaging (why the size is appropriate, why the materials were chosen, why the protective packaging was selected, etc.).
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