Medical device procedure tray - Adding products in Custom packs

K

Kees Fremerij

Starting to get Involved
#1
#1
Does anyone has experience in the following:
A filled injector (gel and/or water) is sterilized (gamma).
This injector needs to be packed in a procedure tray which will be sterilized by EtO. Is it the best way to add it before the EtO treatment or aseptic after the sterilization?
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
Hello Kees and welcome to the Cove :bigwave:

As far as my understanding goes, aseptic technique can help minimize the bioburden, but if you add anything after the EtO sterilization sterility can no longer be guaranteed. So in my opinion the sequence you described is the right one.

The injector and contents will have to be validated post Gamma + EtO, to make sure that process doesn't deteriorate it.

Cheers,
Ronen.
 
P

pkost

Trusted Information Resource
#3
#3
in order to comply with article 12 sterilization requirements you have to follow the sterilisation instructions of the manufacturer...Even thought the product is already sterile, you may still run into this problem....I suspect the manufacturer of the syringe does not provide instructions to use EtO!

Instead of sterilising with EtO and then packing in aseptic conditions, could you not just group them together in the same "non sterile" pack? I have seen this done before.
 
K

Kees Fremerij

Starting to get Involved
#4
#4
The gel will be put in an aluminium pouch instead of a syringe. Gamma irradiated and prior to EtO added to the package. I think this will be the best option.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
A MAH license transfer (medical device registrant) procedure in Indonesia Other US Medical Device Regulations 0
M Informational TGA Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs Medical Device and FDA Regulations and Standards News 2
A Certification procedure for OEM/PLM collaboration in the medical device industry in the US - Who bears the regulatory responsability? Other US Medical Device Regulations 10
alonFAI Please share a medical device company NCMR procedure Other Medical Device Related Standards 5
I Japanese medical device recall requirements & procedure for foreign manufacturers Japan Medical Device Regulations 4
P What is expected in a Medical Device Commercial Release Procedure Design and Development of Products and Processes 3
S What is the procedure to reclassify a Medical Device in Canada? Canada Medical Device Regulations 3
S Medical Device Clinical Evaluation Standard Operating Procedure / SOP Document Control Systems, Procedures, Forms and Templates 12
S Medical Device Clinical Evaluation Standard Operating Procedure / SOP Imported Legacy Blogs 1
somashekar Electronic data Back-up procedure, for Medical device QMS and regulatory purpose. ISO 13485:2016 - Medical Device Quality Management Systems 4
S Medical Device Reporting SOP (Standard operating procedure) example Other Medical Device and Orthopedic Related Topics 1
J Quality Procedure to handle some standard Medical Device Processes Document Control Systems, Procedures, Forms and Templates 1
J Medical Device Procedure Pack IFU's (Instructions for Use) ISO 13485:2016 - Medical Device Quality Management Systems 5
T Medical Device Reporting Procedure ISO 13485:2016 - Medical Device Quality Management Systems 2
E Does MDD (Medical Device Directive) Require a CAPA Procedure? Document Control Systems, Procedures, Forms and Templates 3
J Medical Device Recall Procedure example wanted ISO 13485:2016 - Medical Device Quality Management Systems 1
C Storage Managment (Stock Control and Storage) procedure for Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 3
K Medical Device Software Development Procedure IEC 62304 - Medical Device Software Life Cycle Processes 20
M Non-Conformance Procedure FlowChart for a Medical Device company Document Control Systems, Procedures, Forms and Templates 3
A Procedure for Completing Medical Device Project Plans ISO 13485:2016 - Medical Device Quality Management Systems 5
C Medical Device Reporting procedure - Correction and Removal (21 CFR 806) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Medical Device Advisory Notice Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
M FDA Audit Procedure - SOP - Small Medical Device Company Document Control Systems, Procedures, Forms and Templates 19
Ajit Basrur Control of Medical Device Labels and Labelling Activities - Looking for a procedure Document Control Systems, Procedures, Forms and Templates 17
D Dock-To-Stock procedure - Medical Device Company Document Control Systems, Procedures, Forms and Templates 1
A Mechanical Design Procedure - Infusion pump incorporating software - Medical Device Design and Development of Products and Processes 1
D One Software as Medical Device product or two? EU Medical Device Regulations 2
R How to find the proper the fieids of IVD distributers and develop the medical device markets in Thailand? Manufacturing and Related Processes 0
K Regulatory Aspect of Embedding 4G/5G communication technologies into medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
G Medical Device Auditor (CMDA) certification exam by ASQ - looking for input Career and Occupation Discussions 3
B Documenting Medical Device Complaints after End of Life? Medical Device and FDA Regulations and Standards News 0
M Medical Device License as Distributor Canada Medical Device Regulations 8
M Preparing a document for Raw Material of Medical Device EU Medical Device Regulations 1
R Medical device regulations in African countries Other Medical Device Regulations World-Wide 0
Z Swiss Authorized representative & non-medical device regulations Other Medical Device Regulations World-Wide 0
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 2
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
P Brexit Germany - Import Medical Device For Clinical Study EU Medical Device Regulations 0
M Medical Device Marketing Material - Control of Social Media 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Ed Panek Make sure you hire competent QA RA Folks before making a "Medical Device." Coffee Break and Water Cooler Discussions 1
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
MedicalDevicesCanada How to find a medical device contract manufacturer, MDSAP certified? Canada Medical Device Regulations 5
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
S Medical Device - Technical Documentation structure EU Medical Device Regulations 1
LostLouie Archived Specifications and Drawings for Medical Device Technical Files EU Medical Device Regulations 4
B Reprocessing of an accessory for a medical device EU Medical Device Regulations 4
A Class 1 medical device - Thailand Other Medical Device Regulations World-Wide 0
P Interchangeable/alternative parts in BOM (medical device) Manufacturing and Related Processes 4

Similar threads

Top Bottom