FAQ

As a third party vendor, are you trained to work on various vendors’ equipment?

 

Do you provide both mechanical and PVT testing for dissolution qualification? Is one methodpreferred over the other?

 

What happens if HPLC or Dissolution qualification fails to meet specifications?

 

Will Pion provide training to customers on preventative maintenance and qualification of instruments if we want to perform in-house qualification?

 

Does Pion perform verification of wire mesh sieves?  What procedure does Pion follow?

 

Does Pion do annual contracts on equipment services?

 

What is the typical savings over original manufacturer’s service offerings?

 

Does Pion require a PM prior to performing an OQ or OQ/PV?

 

Our company seems to have issues getting Prednisone to pass PVT.  However when performed by Pion we seem to pass with no problem.  Why is this the case?

 

 

 

As a third party vendor, are you trained to work on various vendors’ equipment?

All of our engineers are trained on the respective equipment they qualify and service.  Many of our service engineers previously worked with these equipment manufacturers and they assist us in the training process.  Pion’s service center contains many different brands of equipment used for annual training and updates.  We provide a copy of training certificates with completed documentation package at time service is performed.

 

 

Do you provide both mechanical and PVT testing for dissolution qualification? Is one method preferred over the other?

Pion provides both the Enhanced Mechanical Qualification and/or the Performance Verification Testing (PVT).  Both types of testing are considered valid qualification processes for your equipment.  Depending on the age of your equipment, certification of all parts, lab processes, and controls one method could work more efficiently in your lab. 

 

 

What happens if HPLC or Dissolution qualification fails to meet specifications?

In the event of an out of specification (OOS) result, Pion will notify customer contact immediately of the finding.  We then recommend following company’s internal investigation SOP for OOS data.  Once approval is given to troubleshoot the problem, Pion will work to resolve issue and provide a re-test plan where applicable.

 

 

Will Pion provide training to customers on preventative maintenance and qualification of instruments if we want to perform in-house qualification?

Pion’s goal is to help our customers.  We do provide paid training options both on-site and at Pion on ways to improve PM and qualification processes.  Our goal is to ensure you are pleased with our support and expertise.

 

 

Does Pion perform verification of wire mesh sieves?  What procedure does Pion follow?

Yes, Pion has been performing re-certification (verification) of wire mesh sieves for over 3 years now.  Pion follows current ASTM method for woven wire mesh test screens. 

 

 

Does Pion do annual contracts on equipment services?

Yes.  Pion offers many options for level of services offered.

 

 

What is the typical savings over original manufacturer’s service offerings?

This ranges depending on the manufacturer, but savings are 20-35% in most cases.

 

 

Does Pion require a PM prior to performing an OQ or OQ/PV?

Pion does not require this, but would highly recommend a PM prior to any OQ.  Many SOPs require this.

 

 

Our company seems to have issues getting Prednisone to pass PVT.  However when performed by Pion we seem to pass with no problem.  Why is this the case?

Prednisone was designed to be very sensitive to setup and mechanical specifications.  However, even with these variables controlled there are many technique-dependent steps that ensure test success.  Pion chemists have been performing PVT services for over 6 years with calibrations on 200+ dissolution testers per year.  This constant attention to detail and experience provides confidence in positive results for testers that are mechanically and operationally sound.