Look I’ve found it!
 
We have to face it; we can be a little lost sometimes!  It’s at these times that Alan can help you and your organisation to find the best way forward.  Due to my experience over many years, it enables me to assist you to efficiently overcome issues which at times can seem insolvable and at best overwhelming.
 
Top 10 examples:
  1.   Equilibration
  2.   Wet steam
  3.   Low temperature problems
  4.   Silicone tubing issues
  5.   Packaging problems
  6.   Validation and Qualification issues
  7.   Regulatory expectations
  8.   Inefficient cycles
  9.   Failed Acceptance Criteria
  10.   Standard/Worst Case/Max-Min loads
 
The above are just a few areas out of a whole host of concerns people have, particularly with moist heat sterilization.  I have regularly worked with companies worldwide, specifically in the USA to help them comply with European GMP expectations.
 
I have provided advice to both Pharmaceutical and Biotechnology companies, globally, to support their purchase and ongoing management of sterilizers. This has included development and/or review of User Requirement Technical Specifications (URTS), taking into account the intended use of the equipment and budgetary challenges, both for purchase and ongoing maintenance.
 
Whatever your concerns are, I’m here to help you.
 
 
Consulting