process validation for injection molding medical components: molders must take rigorous steps to validate the equipment and processes they use to make medical products. here\'s a guide to help.

With the increasing number of measures to meet and improve supplier management monitoring, injection molds for medical products are facing increasing scrutiny from customers.
This paper aims to educate mold personnel on the quality expectations of process validation of their medical device equipment and processes.
It provides general advice on how manufacturers prepare and implement injection molding process validation. [
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What are the requirements for validation and where are they coming from?
Companies supplying products for the manufacture of medical devices in the United States by the Food and Drug Administration in accordance with the quality system regulations 21 CFR Part 820 and the International Organization for standardized (ISO)
Below 13485: 2003.
Both departments have regulations requiring manufacturers to verify the equipment and processes used in the manufacture of medical devices.
In order to meet these requirements, the manufacturer uses three
Step verification process for installation confirmation description (IQ)
Operation qualification (OQ)
Performance Qualification (PQ).
The confusing point is that these specific terms and requirements are not described at the top
Level of attention. Section 7. 5.
2 of ISO 13485, medical devices, quality management systems, and regulatory requirements are as follows: The Organization shall verify any process for the provision of production and services, if the result output cannot be verified by subsequent monitoring or measurement. . . .
This includes any process in which defects will only manifest after the product is used or the service is delivered.
\"The injection molding supplier must provide evidence that the process and equipment are verified and maintained.
For each new product, the verification process follows the same steps and becomes more routine over time.
With several requirements to consider, planning and execution can become difficult and confusing for the first time.
If certain steps are not included, the results of the validation project may pop up.
Molders should plan the steps involved using the following list of activities: 1. Form a multi-
Verify the function Team 2.
Planning method, defining requirements and processes 3.
Specify process parameters and desired output (s)4.
Decide to verify and/or verify 5.
Create master verification plan 6.
Select Methods and Tools for validation 7.
Create verification protocol 8.
Perform IQ, OQ, PQ and record result 9.
Determine the continuous process control of the project from multiple starts
Functional team led by project manager.
The team works with all those who are considered critical to the project, usually including engineering, material management, manufacturing, and quality control.
The project team will define the steps involved in producing products that meet customer specifications.
This is best done by creating a flow chart to summarize each step required to meet the specification.
The customer specification is part of this document and is usually presented in the form of a drawing containing component dimensions and visual requirements.
The specification should also include product performance requirements such as sterilization and environmental/life cycle requirements.
Next, reduce the process parameters to variables called key process parameters (CPP).
These are the process parameters that most influence the key quality requirements of the final product, called the key quality attributes (CQA).
CPPs and CQAs are important because they define the process inputs and product outputs used in the verified OQ and PQ phases.
CPPs is defined by a process subject matter expert who knows which process variables have the greatest impact on the final output specification.
It is prudent to run some preliminary processes to identify these parameters, and perhaps experimental design should be carried out (DOE)
Determine which process parameters are used correctly.
For example: Figure 1 shows a list of typical injection molding process variables.
The left side shows the process parameters commonly used in the process settings.
There are 13 processors to consider in this case.
Many parameters (e. g.
, Assuming that the door has been frozen before, the holding time)
These will remain the same throughout the testing process and should not be considered CPPs.
Evaluate the impact of each parameter on the CQAs and identify those parameters that have the greatest impact.
This filtering process does not reduce non-
CPP process settings, but they are listed separately because they do not have the most significant impact on the product CQAs.
The goal is to eventually focus on three to four cpps in OQ and PQ validation. [
Figure 1 slightly][
Figure 2:
In this example, we will assume that DOE studies have been conducted and relevant analyses have been run to determine the parameters that have the greatest impact on each CQA.
The results show that there are three process variables with high significance, barrel temperature, holding pressure and mold temperature.
Process settings for all other variables are also identified and documented.
Before running the process validation study, the project team will use the 100% process validation to evaluate the option to eliminate validation requirements (
Refer to the flow chart in figure 2).
This is usually not a good option for injection molding, because process validation requires 100% inspections per CQA specification, often without cost-effective processes, unless a certain type of automated process is used to confuse the CQAs.
The master verification plan is a summary of the information covered above, as well as a list of inspection instruments required to measure the CQA specification.
Use the information in the verification plan in each verification step performed.
Here is a list of items reported in the plan: 1.
List of equipment, refer to Process Flow Chart 1.
1 including forming machine, Chiller, Circulator, dryer, part processing equipment 2.
List of materials 2.
1 plastic resin and other materials requirede.
Month of insertmoxing.
Product specifications 4.
List of CQAs with acceptance criteria 5. List of CPPs (
Including preliminary process assessment reports and if DOE is performed)6.
Required inspection instruments 7.
Process research plan for OQ and PQ 7.
1 high on the proposal
End, nominal and low-end CPPs 7.
2 includes the recommended cycle 7 For All process settings.
3 OQ, PQ installation qualification of GSP scheme installation qualification (IQ)
The process starts with writing the atest protocol, which the project team must approve before performing the evaluation.
IQ shall determine that all installation requirements of the equipment and auxiliary systems comply with the manufacturer\'s approved specifications and that all critical process variables are installed and functioning properly.
The IQ of the injection molding machine includes two parts-
Injection molding machine and injection mold for each product verification.
The mold usually performs IQ on a molding machine separated from the target verification mold.
Operate using a sample mold to prove that the molding machine is installed correctly, to comply with all installation suggestions from the manufacturer and to perform all process functions correctly.
After performing machine validation, use this machine to verify duplicate references for each mold.
In this paper, the ison mold verification is made and it is assumed that the verification on the forming machine has been completed.
IQ includes a reference to the molding machine, as well as all supporting equipment required for the mold product.
In order to achieve the above objectives, the protocol must include the following sections: 1. Purpose 2.
Section III approval. Scope 3.
1 List the mold and all the support equipment required 3.
2 Includes reference 4 for forming machines that perform IQ.
Engineering Documents 4.
1 Assembly drawing of injection mold 4.
2 Water-cooled layout plan 4.
3 refer to all manuals required for forming machines and all supporting equipment. 5.
List of all control procedures and operation of molds and all supporting devices 6.
List of materials required for mold and accessory equipment operation 7.
List of all preventive maintenance procedures for molds and ancillary equipment 8.
Tool identification check 8.
1 According to mold engineering file 9, all tools have the correct label.
Mold installation verification 9.
1 install the injection mold correctly according to the engineering Document 9.
2 The installation of the injection system is correct 9.
3 install mold cooling according to specification 10.
Mold function verification 10.
1 mold on/off function free, no need to bind 10.
2 without binding the IQ protocol, the pilot system is free to work, covering the sections listed above and can be saved as a general template for subsequent product qualifications.
Agreement details for each project will be customized for specific project reference information.
After the agreement is approved, it can be executed.
Each part of the agreement must be executed to verify that all checks are performed and must include checks executed and approved by lines and dates to provide evidence of responsibility.
The executed agreement is included as part of the IQ final report, which states that all protocol requirements have been executed and IQ has been successfully completed.
Operation qualification (OQ)
All process control limits and levels of action required to produce products that meet all intended requirements should be established and documented.
Proper planning of the OQ is critical as a lot of time will go into the preparation and execution phases.
A series of process settings must be tested and evaluated to define low-
Finally, nominaland high
End the process challenge setting. All non-
CPP process settings must also be defined and remain the same throughout the qualification process.
If the proposed process results in a rejection of the product, the OQ must be restarted using the revised setting that will produce the approved product.
Once OQ is completed, these process settings will be challenged again in the pq study, using a larger amount of parts over time to challenge the process.
The best plan is to take the time to identify the most powerful process window of the product with the mold and process before writing the agreement.
In order to meet the expected requirements, the OQ should include the following sections: 1. Purpose 2.
Section III approval. Scope 4.
Section IV process requirements.
Product specifications 4. 2 Equipment 4.
3 Raw Materials 4. 4 Tooling 4. 5 Software 4.
6 Operating Procedures for process standards (SOPs)5.
OQ test plan 5.
1 Description of the learning plan 5.
CQA specifications with tolerances and measuring instruments 5.
3 Low CPP settings
End, nominal and high-end process 5. 3.
1 including all other process settings (non-CPP)5.
4. Evaluate the GSP plan and acceptance criteria 6.
Section 6 of process research and testing.
1 Specific test steps spelled out with the record Table 6.
2 Product Inspection Form 6.
3 including calibration requirements 7.
Training requirements for any project, the protocol will follow a similar sequence of steps, which makes the process more routine for subsequent process qualifications.
The qualification plan must include a sampling plan and define acceptance criteria for each CQA specification.
Section 6 on process research and testing will include all the tables needed to record data to prevent confusion during protocol execution.
Documentation that also needs to include traceability of all material lot numbers.
The training requirements section is important because training is often not properly documented or missed.
All personnel who carry out qualification must be trained in all process and equipment-related standard operating procedures.
The effective training section will include the signed line and the date of confirmation of the training.
Ccas is divided into two types of requirements: measurable dimensions and visual attributes.
Visual attributes are subjective, and it would be more effective if the protocol included images of defects to show clear examples that were not accepted.
The test and documentation section must include calibration verification of all required process control and measuring equipment.
Any process variables that have a significant impact on CQAs must be calibrated, so all CPPs identified need to be calibrated.
In addition, any measuring equipment used to inspect the final product must also be calibrated.
Performance Qualification (PQ)
The process shall be established and documented to continuously produce products that meet all intended requirements under expected conditions.
Through more extended manufacturing operations, the execution of the process confirms the robustness of the process and will produce good products over a longer period of time.
The process settings used come directly from OQ and must override the worst-
Case process conditions.
This means that PQ must include an assessment of the processend and high-
End process settings.
Unless the project team wishes to include the product, there is no need to run the product under nominal conditions.
In addition, PQ must include the use of three different batch numbers of materials for product operation evaluation of each process Challenge (low-and high-
Process end settings).
The standard of variation between the three material batches should include consideration of the following other possible changes: * change of equipment * Change of lot/Lot * change of shift/days * Change of tool setting of injection mold PQ should include List of the same parts as OQ and add something.
The execution of PQ provides a high degree of confidence that this process will produce products that meet the specifications for a longer period of time.
The PQ protocol must include requirements and statistical reasons for the number of products tested from each process run study.
The sampling plan is determined by understanding the level of statistical confidence required by the mold and the customer.
The topic of the statistical review is long and therefore not detailed.
As noted in OQ, an examination of CQAs will include an analysis of measurable and visual inspection data.
The visual detection standard is defined as attribute data, and because the result is Passed/Failed, a larger sampling size is required.
The dimension inspection standard produces measurable data.
For measurable data, a smaller sample size is required to analyze the probability of the process of producing a good product within a specific tolerance range.
A typical sampling plan for measurable data requires a minimum of 30 samples.
A typical sample plan for attribute data requires 154 or more samples, depending on the confidence level required.
After the PQ protocol is completed, all data should be aggregated in the final report.
The verification process is now well documented and proven by strict testing that the product will be high
High level of confidence in quality.
The product verification process provides value as it forces the manufacturer to thoroughly test and document the process before mixing production.
The process takes more time and extra material, costupfront, but the work pays off in the long run as it improves product quality and reduces customer and end user
Medical device manufacturers are looking for the best injection molds to produce their products.
Good process validation over time is a key factor in delivering the best product quality.
Author John Anes is an independent consultant with over 30 years of management experience in the development and manufacture of medical devices.
He served as director of operations for manufacturing orthopedic equipment at Zimmer biomet and as vice president of operations and engineering at synvasion Technology.
He also spent more than 15 years working on injection molding at Western medicine services.
Bulk medical packaging system.
He holds a bachelor\'s degree in Plastic Engineering from the University of Massachusetts
Lowell, author of several patents for portable sterile injection filter water and medical devices in the field of orthopedic systems. [
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John Beaumont is the chairman of the American injection molding Institute. www. aim. institute)
Beaumont technology (www. beaumontinc. com)
Both hotels are located in Erie, Pa.
The main task of the AIM Institute is to provide high
Educational programs for training professionals.
Contact: Beaumont @ aim. institute [
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