Mark Dott, LLC

Projects commonly include preparation of validation test protocols, execution of the validation studies, thermal mapping of sterilizer chambers as required,  review and approval of data to insure compliance with ISO published guidelines, preparation of final report(s), preparation of SOPs, and training of client’s employees:

• Steam sterilizer / autoclave validations performed per ISO 17665 - 1

• Gamma radiation validations performed per ISO 11137

• STERRAD (hydrogen peroxide) validations performed per ISO 14937
  

• Advice on SOPs for daily production loads, sterilizer deviations, product families / product adoption SOPs, etc.

Projects may be bid at an hourly rate, or at a fixed-bid price, as appropriate.