The Supplier Perspective: Sterilization. Presented by: Thad Wroblewski STERIS Isomedix Services

Transcription

1 The Supplier Perspective: Sterilization Presented by: Thad Wroblewski STERIS Isomedix Services

2 Agenda Introduction Contractor selection criteria Pre-planning with sterilization in mind Key elements of the relationship Validation considerations Routine processing managing the program Non-conformance issues Contractual elements Commitments to standards Performance reviews Final considerations

3 Introduction Sterilization Technology Process Development Successful Sterilizer - Manufacturer Working Relationship Validation Science Meeting Standards

4 Introduction Sterilization is the last step prior to entering the supply chain Manufacturing Packaging Sterilization End User

5 Contractor Selection Does your contractor fit all the pieces of the puzzle?

6 Pre-Planning with Sterilization in Mind Meet with contractors as early as possible in the process Establish a relationship Not simply a purchasing agreement Understand capabilities of your sterilization provider Process parameters Specialized services Post process handling & distribution Identify a team leader to draw those involved together Critical on the manufacturing side

7 Key Elements of the Relationship Who is the Team on both sides? Sales Technical Support Validation Quality Scheduling Production Purchasing Supply Chain Key Contacts Establish overall relationship, assign roles, track progress, coordinate routine business reviews Materials testing, process / cycle development, validation assistance, protocol development & execution, final reports Facility-specific support & execution Audits, standards / regulations (domestic / international), Customer specs: handling info, assignment of responsibilities, non-sterile shipping agreement, terms & conditions, Quality policy, contract, documentation, reliability & continuous improvement Coordination of product receipt, production process & release to outbound handling Meet Customer processing & handling specs / documentation requirements, capacity & growth management Business relationship management with sales Monitor inventory, shipments to / from contractor, turn-times

8 Validation Considerations Validate according to equipment performance capabilities Validate to manage bumps in the road Non-conformances Facility downtime Contingency planning Throughput planning Technical details Process compatibility: specification related to equipment performance and physics Process interruptions and non-conformances

9 Routine Processing Managing the Program Scheduling Set schedule established Customer understands scheduling Documentation How do you access: , fax, phone calls Product tracking / visibility Product Received by Contractor Process Setup/ Scheduling In Process Non-conformances Ready to Ship Product Released/ Quality Documentation Processing Complete/ Quality Review

10 Non-Conformance Issues Understanding non-conformances What are they and how are they managed? How do you understand non-conformances Facility audit: does the facility have a handle on their performance? CAPA program Liability

11 Non-Conformance Examples (Ethylene Oxide) Aeration Room Temp too low / high Aeration time under / over specification Biological Indicator (BI) Issues Missing / damaged paper carrier or self-contained BIs Positive BIs EO Injection & Dwell EO injection time under / over specification Amount of EO injected under / over specification EP dwell time under / over specification Sterilant Removal Removal too quick (evacuation rate exceeded) Removal too long (additional EO dwell time) Chamber Temperature Temp above / below specifications Missing Data or Records Too much / too little steam Shorter / longer dwell time Product Damage Unreported / excessive damage Other Control system Incorrect cycle Missing data or records

12 Corrective Action Examples (Ethylene Oxide) Cycle Phase Phase Purpose Out of Limit Condition Corrective Action Disposition Action Analysis Gas Injection Gaseous ethylene oxide in admitted to the chamber to the minimum validated concentration Gas injection pressure too low Adjust gassing pressure or correct supply error to within acceptable limits Accept if minimum injection delta is met. Reprocess if less than minimum conditions were delivered Failure to meet minimum gas concentration does not meet the minimum validated conditions. Load must be reprocessed Exposure Dwell Deliver the required lethality to the load mass Exposure pressure to low Adjust gassing pressure or correct supply error to within acceptable limits Accept if minimum injection delta is met. Reprocess if less than minimum conditions were delivered Failure to meet minimum exposure gas concentrations does not meet the minimum validated conditions. Load must be reprocessed Aeration To heat the load mass to accelerate the de-gassing process Room temperature below specification Once normal room conditions are reestablished, extend load residence time by the amount of time the room was below specification Accept The amount of heat loss during the out of limit condition will be replaced once the room reaches normal operating conditions and the residence time is extended

13 Corrective Action Examples, Cont. (Ethylene Oxide) Cycle Phase Phase Purpose Out of Limit Condition Corrective Action Disposition Action Analysis Environ-mental Pre- Conditioning (PCR) To heat and moisturize the load mass to known conditions prior to entry into the sterilizer Room temperature below specification Once normal room conditions are reestablished, extend load residence time by the amount of time the room was below specification Accept The amount of heat loss during the out of limit condition will be replaced once the room reaches normal operating conditions and the residence time is extended Ethylene oxide when mixed with air if a very volatile mixture and could result in a very hazardous condition if allowed to proceed. If a hazardous mixture has occurred, abort and assure the post exposure reevacuations and washes are completed in their entirety Leak Test Nitrogen Dilution(s) To assure that the chamber integrity remains integral prior to gas injection To assure that an ample amount of air is removed from the chamber to assure a safe atmosphere for EO admission to the chamber Leak test pressure greater than limits Injection pressure less than specified limits Caution! Safety may be compromised. Determine if safety is an issue and abort cycle if prior to gas injection Caution! Safety may be compromised. Determine if safety is an issue and abort cycle if prior to gas injection Reprocess if aborted Reprocess if aborted. If the process was completed, accept if minimum conditions at minimum time were delivered

14 Contractual Elements Agreement has all minimally necessary elements and meets all medical / drug standards Identification of the relationship We are the processor Sterile label claim belongs to the Customer We will meet specification Warranties / remedies / liabilities Confidentiality: protecting of trademarks, proprietary info Pricing: initial, escalation considerations (service-side) Indemnity Insurance Length Commitment to standards

15 Performance Reviews Important to review for continuous improvement, reliability, problems Review performance metrics Volume processed Turn time Non-conformance review Damage Complaints Payments

16 Performance Reviews, Cont. Also important to review metrics on an ongoing basis

17 Final Considerations Relationship approach is required Both parties strive to always do what is right with a voice of reason reflecting the requirements for producing a safe, functional and efficacious product and assuring that mutual business goals are met, creating value to the relationship