Workshop on Setting Acceptance Limits for Cleaning Validation of Medical Devices
(In-person only event)
Date: May 9, 2023
Event Location: Sheraton Denver Downtown Hotel, Denver, Colorado
Organized by: ASTM Committee F04 Medical and Surgical Materials and Devices
About the Event
Abstracts for presentation at the Workshop on Setting Acceptance Limits for Cleaning Validation of Medical Devices to be held on May 9, 2023. The workshop is organized by ASTM Committee F04 Medical and Surgical Materials and Devices, and will be held at the Sheraton Denver Downtown Hotel, Denver, Colorado in conjunction with the May standards development meetings of the committee. The language of the workshop will be English.
Objective and Scope
This workshop will identify current best practices in setting acceptance limits in cleaning of medical devices, gaps in standardization of this practice, and areas where new standards would be useful. Considerations include crossover with ISO 10993 standards and potential updates to these requirements.
Topics include, but are not limited to:
- Case studies of cleaning with issues associated with acceptance limits
- Current standards on cleaning of medical devices
- Types of residues and considerations
- Include manufacturing residues, particles, environmental agents, cleaning agents
- Exogenous factors
- Knowing what your manufacturing materials are composed of
- Methods for establishing acceptance limits
- Historical clinical history
- Toxicological risk assessment
- Cytotoxicity
- Patient risk assessment
- Approaches for using acceptance limits in cleaning validation
- How cleaning affects sterilization
- How cleaning affects biocompatibility
- Consistency of cleaning process
- Impact of cleaning on device functionality or user experience
- Risk assessment in using acceptance limits
- When to modify acceptance limits
- Approaches to limit establishment when there is a change in manufacturing process
- What are the gaps in acceptance limits guidance?
- The pharmaceutical manufacturer position on acceptance limits
- Regulatory perspective on setting limits and rationale
- Development of proposal(s) for development of new ASTM standards related to acceptance limits for medical devices
Technical Program
Registration
Registration is now open. The fees to attend this event are listed below.
This is an in-person only event.
|
Through April 7, 2023 |
After April 7, 2023 | |
|---|---|---|
| ASTM Member | $215.00 | $265.00 |
| Non-member | $265.00 | $315.00 |
| Presenter | Waived | Waived |
| Student | Waived | Waived |
All Attendees – All attendees are urged to register for this workshop before arriving onsite. All attendees must check in at the ASTM Registration Area to obtain their name badge before entering the event room.
Presenters -- Presenters' fees are waived; ASTM will register workshop presenters on their behalf.
Students – Students may be eligible for a reduced registration fee provided they meet certain requirements. To qualify for the reduced fee you must be a full-time student, not employed full-time, and be able to provide a current valid university email address for registration. To register as a student, please email ASTM Symposia Operations at symposia@astm.org.
Cancellations – A refund of the workshop fee will be honored only if requested at least 10 business days prior to the start of the event. To cancel your registration and request a refund, please contact Symposia Operations at symposia@astm.org or 610-832-9522.
If you have questions concerning online registration, please contact Symposia Operations at
symposia@astm.org Tel: 610-832-9522, or ASTM Technical Support at support@astm.org or 1-877-909-2786 (domestic) or 610-832-9578 (international).
Technical Chair Contact Information
Stephen Spiegelberg
Cambridge Polymer Group
Email: stephen.spiegelberg@campoly.com
Ralph Basile
Healthmark Industries Co
Email: rbasile@healthmark.com
Continuing Education Units
Workshop attendees interested in receiving 0.7 Continuing Education Units (CEUs) must complete the CEU application form in the back of the program booklet and email it to ASTM Symposia Operations at symposia@astm.org. You must be registered and have attended the entire event in order to receive the CEU’s. A certificate will be sent to you via email approximately 1 to 2 weeks after the workshop concludes.
Hotel Information
To book accommodations under the ASTM Rate, please click here: Sheraton Denver Downtown Hotel Reservations.
The discounted rate will be honored until the ASTM block is full, but no later than April 7th, 2023. The ASTM rate is $209 plus tax. You may be charged a higher rate if reservations are received after the cut-off date, or when the block is full. The hotel requires a credit card to guarantee your reservation, once submitted a confirmation number will be provided electronically. To book accommodations using the ASTM rate, please click the link below.
CANCELLATION/CHANGE POLICY: At the Sheraton Denver Downtown Hotel, notice of cancelation must be received 3 days prior to day of arrival in order to avoid a charge. Failure to do so will incur a penalty equal to the cost of one night's room and tax.
The May Committee Week Hotel provides prime meeting space for your committee meetings, events and activities. ASTM International is legally bound to fill the contracted guest room block and an inability to fill the block will result in severe financial penalties which could affect negotiations and increase costs for future meetings.
INTERNET: The Sheraton Denver Downtown Hotel offers free wireless to Bonvoy Members.
Standards Development Meetings
Committee F04 invites you to attend their future standards development meetings. There is no fee to attend these meetings, and membership in ASTM International is not required to attend. For more information about the committee and it's future meetings, please visit the F04 homepage on the ASTM website.