How many Pieces to Test - Sterility Testing USP

M

mpfizer

Involved In Discussions
#1
#1
we have a validated procedure for eto sterilisation as per ISO standard . now we send say a batch off 100 number and after that we want to conduct sterility test as per USP how many pcs do we need to test? one or more and why ?
Thanks
 
Download Free White Paper
Elsmar Forum Sponsor
C

Chrisx

Involved In Discussions
#3
#3
The sample size has to be such that it reduces the risk as far as possible. This is necessary to comply with the MDD. Unfortunately, this means you must approach 100% destructive testing to comply with the MDD. :(

Sorry, being a jerk, but it is an unworkable regulation. In reality, it depends upon what you the purpose is of your sterility testing. The sterilization standards typically stipulate quantities for sterility testing. Each method has it's own standard. Sterility testing cannot replace sterilization validation. If you have not validated your sterilization process, you are in very high risk for regulatory action from regulatory agencies all over the world (US, EU, everywhere).
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
C AS9102 - How many pieces need to go on the First Article paperwork? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M How many pieces are recommended to release PCA study? Statistical Analysis Tools, Techniques and SPC 4
J GM PPAP Specific Requirements - How many pieces for layout, submission - Gage R&R? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R How many process maps are adequate for a company for IATF 16949? Process Maps, Process Mapping and Turtle Diagrams 17
V How many hrs does it take to create a Technical File (TD)? EU Medical Device Regulations 4
G How many Design FMEAs do you have? FMEA and Control Plans 4
V Literature search over how many years? EU Medical Device Regulations 8
S How many tester quantity we need on the line based on the cycle time and peak volume Manufacturing and Related Processes 3
M R&R Studies - how many? per product? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
J How many majors is one company allowed ? IATF16949 Manufacturing and Related Processes 16
M Summative evaluation: how many sample per participant? IEC 62366 - Medical Device Usability Engineering 5
J How many hours for a NB to review Technical Documentation? EU Medical Device Regulations 6
T Too many NC's/ Deviations and CAPAs galore Nonconformance and Corrective Action 10
B How many nonconformances have you received on average during IATF audits? General Auditing Discussions 27
G Too many customer complaints Customer Complaints 16
I How many gauges in a Go/No Go Gauge? General Measurement Device and Calibration Topics 7
BeaBea How Many Processes should be created for each Department? Process Maps, Process Mapping and Turtle Diagrams 5
Watchcat How Many Notified Bodies are "Enough" Already? EU Medical Device Regulations 23
S How many mandays required for the below mentioned standards IEC 27001 - Information Security Management Systems (ISMS) 3
N MDR review process by notified body - How many steps exist in the review process EU Medical Device Regulations 0
F How many signatures do we need on calibration certificates? ISO 17025 related Discussions 8
M Informational From RAPS – Operating System Vulnerabilities in Many Medical Devices, Germany’s BfArM and Device Firms Warn Medical Device and FDA Regulations and Standards News 0
R Validation of Medical Device Hardware containing Software - How many to Validate ISO 13485:2016 - Medical Device Quality Management Systems 1
K How Many Samples to send for Chemistry Testing Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
N MDSAP Participants 2019 - How many companies are participating YTD? ISO 13485:2016 - Medical Device Quality Management Systems 20
S How many of you are using Robotic process automation for calibration lab management? ISO 17025 related Discussions 0
G Measuring customer parts on a CMM - How many decimals to report to the customer? ISO 17025 related Discussions 28
J Supplier choice limitation - Many of them dont have PSCR, VDA or even ISO 9001 VDA Standards - Germany's Automotive Standards 0
O Clean room performance qualification (pq) - How many times can I do each test? Manufacturing and Related Processes 8
G How many samples you require to test during PQ for validation of a equipment? ISO 13485:2016 - Medical Device Quality Management Systems 1
D IATF 16949: Do we have too many processes? Are they all the same? Registrars and Notified Bodies 7
D QMS Performance Based on how many NCRs were generated month to month Nonconformance and Corrective Action 8
S How many QMS processes and procedures? ISO 13485:2016 - Medical Device Quality Management Systems 2
L How many of you are Certified to IATF 16949 IATF 16949 - Automotive Quality Systems Standard 12
G How many Uncertainty Measurements for Micrometers and Calipers? Measurement Uncertainty (MU) 3
R How many Corrective Action Request can be Issued by DCMA for a single issue? Nonconformance and Corrective Action 2
A Training Program Help - Old docs, new docs, so many docs... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Are we an outlier for so many variations of Change Management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M SPC with many data points from one dimension Statistical Analysis Tools, Techniques and SPC 16
S How many times do you have the term 'Requirements' in your Quality Manual? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
L How many working hours to required to implement ISO 14001 ? ISO 14001:2015 Specific Discussions 6
B ISO/TS16949 Internal Auditing - How many auditors? Internal Auditing 4
R Training Production Employees When We Have SOOO Many SOPs Training - Internal, External, Online and Distance Learning 9
P Scope Extension Audit - How many days? Do I audit all AS9100 requirements? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J How can I manage Occurence Rates in FMEA efficiently when I have many processes? FMEA and Control Plans 9
V How many times the quality agreement has been invoked? ISO 13485:2016 - Medical Device Quality Management Systems 3
C How to document many document control systems with one Document Control Procedure? Document Control Systems, Procedures, Forms and Templates 6
A How many laboratories are accredited to ISO 17025 in the USA? ISO 17025 related Discussions 5
R Is it possible to randomly select samples from 1 column to many column Using Minitab Software 2
L How many ISO Standards are there and time allowed for Closing NCs? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2

Similar threads

Top Bottom