Cleanroom Monitoring Plan - ISO14644-2:2015 - Risk Assessment

chris1price

chris1price

Trusted Information Resource
#1
#1
Hi, I am looking for a sanity check...….. I was recently reviewing a Class 8 cleanroom and asked about routine monitoring and whether they had a Monitoring Plan, (as per ISO14644-2:2015 chapter 4). In practice, the cleanroom is subject to an annual re-certification and the monitoring frequency is 12-months. Consequently, other than the annual recertification, no other monitoring is performed and no Monitoring Plan or risk assessment justifying the 12-month period has been performed.

Looking back through ISO14644-2015, I can't see anything discussing the monitoring frequency, other than saying it should be specified. Can you simply provide a Risk Assessment saying once every 12 months is sufficient?

Chris
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
I

indubioush

Quite Involved in Discussions
#2
#2
Can annual monitoring even be considered monitoring? Having a risk assessment present is one thing, but would the content of that document really be able to justify annual "monitoring"? How would they possibly catch any excursions?
 
Q

QM_123

Starting to get Involved
#3
#3
I know some manufacturers and all perform annual monitoring ( unless there is any condition which require revalidation). I will be so glad if anyone say something: Is 1-year period monitoring really sufficient?
 
I

indubioush

Quite Involved in Discussions
#4
#4
I would say annual monitoring would only be okay if the following were true:
- Particulates pose no or extremely low risk to the product.
- There was a previous period of monitoring at greater frequency showing the level of particulate remained the same over time.
- No changes have occurred which would affect the level of contamination (e.g., number of people have stayed the same, the product is the same, equipment is the same).
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
J Cleanroom Differential Pressure Monitoring, frequent manual observation US Food and Drug Administration (FDA) 6
J ISO 14644 - Monitoring Clean Room Particulates (Class 8 Cleanroom) Other ISO and International Standards and European Regulations 4
C Are you operating a class 9 cleanroom? Share cleanroom monitoring results? ISO 13485:2016 - Medical Device Quality Management Systems 3
N Cleanroom Classification Change Other Medical Device Related Standards 7
P Using Zinc Plated Steel in a Cleanroom Other Medical Device Related Standards 3
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
C Cleanroom - 209E to ISO14644 Other Medical Device Related Standards 2
P Surgical masks ( type IIR) - Cleanroom Requirements EU Medical Device Regulations 3
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4
D Cleanroom Cleaning Products and Storage Other Medical Device and Orthopedic Related Topics 18
C Looking for source of silicone contamination in ISO Class 8 Cleanroom Other Medical Device Related Standards 2
I Cleanroom Actions in case of Actions Limit Alarm Qualification and Validation (including 21 CFR Part 11) 3
W How to bring Cardstock into Cleanroom Environments Manufacturing and Related Processes 1
S Looking for ISO Class 8 Cleanroom Cleaning Procedure example ISO 13485:2016 - Medical Device Quality Management Systems 1
D Use of hand cream inside gloves in the cleanroom for medical devices Occupational Health & Safety Management Standards 7
T Converting an ISO Class 8 Cleanroom to ISO 7 Various Other Specifications, Standards, and related Requirements 4
jkuil Cleanroom Equipment and Furniture Engineering Standards Other Medical Device Related Standards 2
T Cleanroom Certification Duration Other ISO and International Standards and European Regulations 1
E ISO Class 8 Cleanroom Qualification Protocol Template Other Medical Device and Orthopedic Related Topics 6
B Cleanroom Control Limits: Cumulative or individual? Statistical Analysis Tools, Techniques and SPC 11
I FDA Cleanroom requirements for class II in vitro medical devices US Food and Drug Administration (FDA) 1
C Cleanroom Disaster Recovery for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 8
A Guidance for Cleanroom Qualification and Validation relevant for EU and USA ISO 13485:2016 - Medical Device Quality Management Systems 2
E Is Volumetric Air Sampling required for Class ISO 7 Cleanroom ? ISO 13485:2016 - Medical Device Quality Management Systems 1
B How to set Cleanroom Alert and Action Limits as part of Microbiological Evaluation Quality Assurance and Compliance Software Tools and Solutions 8
C What is an acceptable bioburden level or count when working in cleanroom ISO class7 ISO 13485:2016 - Medical Device Quality Management Systems 1
W ISO 14644 Cleanroom Validation - "Operational" Other Medical Device Related Standards 3
E A sink with water in an ISO Class 7 Cleanroom ISO 13485:2016 - Medical Device Quality Management Systems 4
W Thoughts on having Safety Shower in ISO Class 7 Cleanroom ISO 13485:2016 - Medical Device Quality Management Systems 5
C Cost Factors of Iso 8 vs. ISO 8/9 Cleanroom Other Medical Device and Orthopedic Related Topics 2
W Cleanroom Cleaning Agents for cleaning a Class 7 Cleanroom Other Medical Device and Orthopedic Related Topics 9
V Making Solar cells, Module, String - Which Cleanroom Level? Various Other Specifications, Standards, and related Requirements 2
H What is the ISO Class 7 cleanroom requirement on Temperature and Humidity ? Manufacturing and Related Processes 4
J Do I need a Cleanroom to manufacture Medical Devices? ISO 13485:2016 - Medical Device Quality Management Systems 4
C ISO 13485 Class 7 Cleanroom Requirements ISO 13485:2016 - Medical Device Quality Management Systems 7
J Yearly Cleanroom Revalidation Test Requirements - Questions for users clean room ISO7 Qualification and Validation (including 21 CFR Part 11) 5
D Cleanroom Housekeeping and Personnel Hygiene Audit Checklist Other Medical Device Related Standards 25
C Cleanroom Class 8 (100,000) Particulate Control and Warning Limits Statistical Analysis Tools, Techniques and SPC 1
N Dehumidified (Dry) Cleanroom - Running a Cleanroom at very low RH Manufacturing and Related Processes 23
somashekar Use of Pencil in Class 1000 Cleanroom ISO 13485:2016 - Medical Device Quality Management Systems 12
S Cost Surrounding Cleanroom Construction Manufacturing and Related Processes 4
M Cleanroom Qualification and Standard Cleanroom Audit Checklist Process Audits and Layered Process Audits 6
C Pest Control - FDA approved list of Pesticides to use for Pest Pontrol in a Cleanroom Other Medical Device and Orthopedic Related Topics 10
B Checklist for Housekeeping and Cleaning of Class 10k Cleanroom? Other Medical Device and Orthopedic Related Topics 17
R Cleaning Procedure for a Cleanroom Class 7 & 8 ISO 13485:2016 - Medical Device Quality Management Systems 2
L Cleanroom Requirements for Nuclear Components Assembly Design and Development of Products and Processes 4
L Validation of transfer materials - Bioburden of items from lab into cleanroom Other Medical Device and Orthopedic Related Topics 2
A Cleanroom class in semiconductor Other ISO and International Standards and European Regulations 8
A Particle Counter Results - Interpreting Data for a Class 100,000 Cleanroom Other Medical Device Related Standards 12
H Cleanroom vs. Clean hood - MIL-PRF-38534, Class K (space level) for hybrids Manufacturing and Related Processes 3

Similar threads

Top Bottom