Process Validation of Thermoforming Process
“Process validation means establishing by objective evidence that a process consistently produces a result or
product meeting its predetermined specifications.”
https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-
process-guidance-04010.pdf
The basic principles of process validation must:
Establish equipment capability to operate within parameters
Demonstrate that equipment and instrumentation are capable of operating within the parameters
Perform replicate cycles or runs, representing the required operational range of the equipment
Monitor the validated process during routine operation
Requalify and recertify the equipment as needed
Process Validation Plan
What to verify/measure
How to do it and how many to do
When to do it
Content of Validation Protocols
Identify the process(es) to be validated
Identify the device(s) to be manufactured using this process
Set objective and measurable criteria for a successful validation
Specify the length and duration of the validation
Determine shifts, operators, and equipment to be used in the process
Identify utilities for the process equipment and the quality of the utilities
Identify operator qualification
Provide a complete description of the process
Stipulate relevant specifications that relate to the product, components, manufacturing materials, etc.
Note any special controls or conditions to be placed on preceding processes during the validation
Specify process parameters to be monitored, and methods for controlling and monitoring, such as:
Product characteristics to be monitored and method for monitoring
Any subjective criteria used to evaluate the product
Definition of what constitutes nonconformance for both measurable and subjective criteria
Statistical methods for data collection and analysis
Consideration of maintenance and repairs of manufacturing equipment
Criteria for revalidation
Format of a Basic Medical Device Process Validation Protocol
Title page
Table of contents
Signature page
General
Purpose/scope of protocol
Why you are doing the protocol and general background
Scope of the protocol, including goals
Reference documentation
External considerations
System description
Responsibilities
Major players on validation and any external experts
Responsibility matrix for various departments
Execution procedures documentation
How protocols will be executed
Needed SOP training for personnel
Recordkeeping
Test equipment
List of equipment to be used plus certificates of calibration
Specific procedures to be used
How parameters will be set, monitored, and controlled
Instructions for conducting visual inspections
Visual inspection
Equipment components
Instrumentation
Full list of instruments with SOPs
Utility verification
Full list of all critical and noncritical utilities applicable to the process
Summary report
Approval page
Installation Qualification (IQ)?
1. Components and equipment
2. Software and standard operating procedures (SOP)
3. Calibration and testing
4. Installation
5. Software and systems testing
6. Records
7. Electrical
8. Signals and alarms
9. Revalidation, facility conditions, and documentation
There should be an SOP, checklist, or some other documented process that defines the standard installation procedure for
each type of system or deliverable being installed. This is required for any equipment used in the manufacturing process. IQ
verifies and documents that key aspects of an installation meet approved requirements. These requirements may come from:
Design specifications
System specifications
Manufacturer’s recommendations
Developer’s recommendations
Data sheets
