May 7, 2014

When it comes to packaging systems used for terminally sterilized medical devices, preserving sterility until use can literally be a matter of life and death. That’s why it’s so important for medical device manufacturers (MDMs) to ensure that the forming, sealing and assembly of sterile barrier systems (as well as the sterile barrier systems themselves) meet ISO 11607-2 requirements for IQ OQ PQ validation. However, there is quite a bit of mystification when it comes to understanding compliance with this standard. Test your IQ OQ PQ validation IQ by taking the Quiz below. 

Do you need IQ OQ PQ validation for thermoformed trays to be 11607 compliant? 

a) Yes 
b) No 
c) It Depends 

The correct answer, like so many in the packaging industry, is c) It Depends. Here’s why: 




Thermoformed Tray 
(with sealed lid) 

Clause 5.1.1 of 11607-2 states that “Preformed sterile barrier systems and sterile barrier system manufacturing processes shall be validated.” Therefore, the sealing process that seals trays and lids together must be validated. 


Thermoformed Tray 
(no lid) 

By definition, a thermoformed tray is not a preformed sterile barrier system (SBS) until a lid is sealed to it – usually by a medical device manufacturer (MDM) or a contract packaging company. Therefore, ISO 11607-2 does not stipulate that thermoformed trays have to be manufactured on a validated process.  

Since a thermoformed tray can be a critical component of a SBS, many MDM’s still impose the requirement that the processes used to manufacture thermoformed trays that they will be using are validated. For this reason, it is important to work with a progressive thermoformer that routinely performs IQ, OQ and PQ validation on their processes and can readily comply with this requirement if requested by their customers. 

Trays in pouches 

When putting an open thermoformed tray into a pouch, the tray itself is not a SBS or performed SBS (the pouch is the sterile barrier). As such, there is no requirement in ISO 11607-2 that the process that made it must be validated.  

If there are dimensions, under cuts or retention features of the tray that are critical, it is considered best practice to validate the forming process to ensure a consistent packaging system. Again, working with a thermoformer that has extensive experience with performing IQ, OQ and PQ validation can ensure this step can be easily completed. 

Form, Fill, Seal (FFS) Processes 

Clause 5.1.1 of ISO 11607-2 gives the example of “rigid and flexible blister forming” as a sterile barrier system manufacturing process that must be validated. While these terms have led many to incorrectly assume that the validation requirement applies to thermoformed trays being made by thermoforming companies, the intent for this language was to ensure that Form, Fill and Seal (FFS) processes, in which rigid and flexible films are formed prior to the device loading and have lid stock sealed to them, are validated. 


Of course, the chart above is only an overview. 

Knowing when the requirement for IQ OQPQ validation is mandatory, when it may be optional, and when it may be necessary (for reasons of patient safety or requirements set for by MDMs) requires a high level of experience and expertise. That’s why at TEQ we have partnered Curt Larsen and John Spitzley of Spartan Design Group, who served on the Working Group 7 Packaging, of ISO Technical Committee 198 to develop the first as well as the 2006 version of both parts of the ISO 11607 standards. They have not only helped us build a strong base plan for IQ OQ PQ validation (see below) but can also help us make IQ, OQ and PQ recommendations and custom plans for our medical packaging customers, helping them to make the most informed decision possible when it comes to process validation. 

TEQ base plan for IQ OQ PQ validation of thermoformed sterile barrier systems 


Machines used for thermoforming the package installed per manufacturer specifications 

QF6-4101 set-up checklist complete 


Optimum operational settings (oven temperature and mold temperature) established 

A run of not less than 100 shots produced 

30-300 samples pulled for a dimensional study 


Three runs (>=two hours) produced using the nominal process settings 

30-300 samples pulled from each lot for a dimensional study 

What about you? Did you pass the quiz? And, perhaps more importantly, what steps do you have in place to ensure that your medical packaging sterile barrier system manufacturing process is properly validated?