SBS - The best value in QMS software

Sterilisation of IV Bags used for Veterinary Blood Plasma Products

Nash27

Involved In Discussions
#1
I hope that you may be able to help me with a question regarding our sterilisation of empty IV bags.

We currently manufacture and sterilise an empty 100mL IV bag (complies with all EU requirements for IV bags) that is later sterile-filled by one of our customers with a veterinary solution of concentrated haemoglobin.
We use sterilisation facility in the Europe (ISO 13485 Certified) to perform this sterilisation against ISO 11137 and the process has been validated.

Is it now necessary to have this empty bag sterilised at a EMA/GMP Certified facility as our client feels that the empty bag might now be a “pharmaceutical”, is this correct?

I really appreciate any help or further direction you may be able to give me.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#4
I hope that you may be able to help me with a question regarding our sterilisation of empty IV bags.

We currently manufacture and sterilise an empty 100mL IV bag (complies with all EU requirements for IV bags) that is later sterile-filled by one of our customers with a veterinary solution of concentrated haemoglobin.
We use sterilisation facility in the Europe (ISO 13485 Certified) to perform this sterilisation against ISO 11137 and the process has been validated.

Is it now necessary to have this empty bag sterilised at a EMA/GMP Certified facility as our client feels that the empty bag might now be a “pharmaceutical”, is this correct?

I really appreciate any help or further direction you may be able to give me.
Not an expert on this, but if I was in your shoes I would start by asking this esteemed customer for a pointer to the legislative instrument which contains, or refers to the definition of a "pharmaceutical" which they believe applies to your bags. From there I would continue to sorting out what requirements apply in this specific instance, including sterilisation facility certification.

Cheers,
Ronen.
 

Nash27

Involved In Discussions
#5
Thanks Ronen,

The customer's EMA consultant requires EU sterilisation facility to be GMP certified, which they have, but apparently their GMP certificate on Eudra/GMP site appears to be expired. I will definitely look other side of story by asking to the customer, cheers.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
The customer's EMA consultant requires...
By that do you mean someone from EMA or just a private consultant helping them comply?

Either way, I don't think it'd be improper to "challenge" that "consultant" - if it's actually someone from EMA you'd have an authoritative statement to work with; if a private consultant, then at least the legislative context would be clarified (and you could also go for a 2nd opinion).

Cheers,
Ronen.
 

Nash27

Involved In Discussions
#7
Its UK based customer consultant, anyway thanks for your help, we decided to move to new sterilisation facility based in UK (Isotron Swindon) they got all compliance including GMP certification from EMA.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Its UK based customer consultant, anyway thanks for your help, we decided to move to new sterilisation facility based in UK (Isotron Swindon) they got all compliance including GMP certification from EMA.
Good luck and I hope you have a smooth transition, which is seldom obvious... :)
 
Thread starter Similar threads Forum Replies Date
chris1price EtO Sterilisation Consultant Wanted Job Openings, Consulting and Employment Opportunities 0
J EU countries and steam sterilisation protocol EU Medical Device Regulations 0
M Is there an Industry Norm for Expiry of Sterilisation Validity? EU Medical Device Regulations 6
N ETO Sterilisation Validation - EO Residual Minimum Sample Requirement ISO 13485:2016 - Medical Device Quality Management Systems 2
N ISO 11135 Monitoring Routine ETO Sterilisation Parameters Other Medical Device Related Standards 3
A Eto Sterilisation Re-Validation Requirements Other Medical Device Related Standards 4
Q Sterilisation ISO 11135 EtO-in-a-Bag (Novel Non-Traditional EtO Sterilization) Other Medical Device Related Standards 12
J Sterilisation Validation of Re-Usable Hospital Instruments ISO 13485:2016 - Medical Device Quality Management Systems 1
P ETO Sterilisation of Single Use Part supplied in Non-Sterile State EU Medical Device Regulations 12
I Correct Label Symbol to be used for Steam Sterilisation ISO 13485:2016 - Medical Device Quality Management Systems 3
T ETO Product Sterilisation Testing Standard Requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
B ISO13485 Sterilisation Validation, Risk Management, Post Market Surveillance ISO 13485:2016 - Medical Device Quality Management Systems 13
J Sterilisation Validation - VDmax for e-beam ISO 13485:2016 - Medical Device Quality Management Systems 12
C ISO 11137:1995 Sterilisation of healthcare products - Amd1:2001 ISO 13485:2016 - Medical Device Quality Management Systems 11
Aliken Container for the blood bags and medicines EU Medical Device Regulations 2
T Corrosion in Bores after Zinc Plating machined Iron Castings in VCI Bags Manufacturing and Related Processes 1
A AQL sampling bags of parts Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
C Looking for RED ESD Bags that preferably say NON-CONFORMING Manufacturing and Related Processes 5
K Colour Code Requirements for Waste Bins/Bags Other ISO and International Standards and European Regulations 2
D Standards for Drop Testing of Valve Bags Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
C Cotton Swab Method Validation for clean uniforms, bins and poly bags Other Medical Device and Orthopedic Related Topics 4
R Use of Valve Bags for Medical Grade Polymer Manufacturing and Related Processes 1
Q Are Sealed Bags and Carrying Cases Medical Devices? US Food and Drug Administration (FDA) 4
C ESD Bags and Paper Labels (Dymo) on the Bags (Packaging) Misc. Quality Assurance and Business Systems Related Topics 5
R Plastic Bags for Sterile Knees - Can this be true? Other Medical Device and Orthopedic Related Topics 8
K Medical Devices QC Testing Procedure - Flexible Medical Solution Bags ISO 13485:2016 - Medical Device Quality Management Systems 5
Judy Abbott General temperature used in the blasting process and laser process Manufacturing and Related Processes 2
R Tools used for measuring (New to metrology) General Measurement Device and Calibration Topics 9
L Requirements for Cables used for Low-Voltage DC Mains (12-36VDC) IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
N Voltage Doubler fail - can gas tubes be used? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
N Maximum mains voltage used when applying 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
W How long do you keep information about equipment no longer used? Document Control Systems, Procedures, Forms and Templates 2
S Calibration Frequency for Slip Gauge Kit used for CMM Calibration? General Measurement Device and Calibration Topics 0
Q PPT used as Design Review ISO 13485:2016 - Medical Device Quality Management Systems 3
G Calibration of "Master Parts" Used as Gauges Calibration Frequency (Interval) 5
R IEC 60601-1 - Magnesium oxide used for the electrical insulation of heating elements IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L Does a backdate form format can be changed if wrong revision is used? Document Control Systems, Procedures, Forms and Templates 8
R Nanomaterials used as coating on class I MD - rule 19 EU Medical Device Regulations 4
E SIP/SOP requirements for USB port used for charging IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
D Can PFMEA be used in disposition of NC material? ISO 14971 - Medical Device Risk Management 4
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
John Broomfield Informational Terms used in quality management [Deleted] Misc. Quality Assurance and Business Systems Related Topics 6
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Standard used to determine if check fixture gauge is acceptable Reliability Analysis - Predictions, Testing and Standards 2
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
G Devices from IQ, OQ or PQ process to be used for verification, validation and summative? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Q LOT or Serial Number Symbol not used when the information is contained in the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
I Approved Suppliers ISO/IEC 17025:2017 and used test equipment ISO 17025 related Discussions 6

Similar threads

Top Bottom