Cleanroom Log Book - Does anyone have an example of a Cleanroom Log?

ISOsandy

Inactive Registered Visitor
#1
In continuing with our cleanroom, we are looking at the logbooks.
The thinking is, small cleanroom, only one person (mabe two) will be in and out of the room.
We wanted to create a log book for the room which would also include the equipment use... any ideas, thoughts??

Does anyone have an example of a cleanroom log?

Thanks for any advice!
Sandy:thanx:
 
Elsmar Forum Sponsor

BradM

Staff member
Admin
#2
Sandy,

Most of the logbooks I have seen have resembled a simple spreadsheet. They have been very simple: date-activity-description-and signature. More importantly will be what you document in the logbook and archiving it. For example, you may want to document adjustments, flow verification, movement of equipment, weekly cleaning, etc.

but to your question, if you have other logbooks servicing other equipment, do you see any reason not to use it for the clean room? That way you don't have to create a new book just for it. Or, go ahead and make up a simple logbook to use for all your equipment.
 

Jim Wynne

Staff member
Admin
#3
In continuing with our cleanroom, we are looking at the logbooks.
The thinking is, small cleanroom, only one person (mabe two) will be in and out of the room.
We wanted to create a log book for the room which would also include the equipment use... any ideas, thoughts??

Does anyone have an example of a cleanroom log?

Thanks for any advice!
Sandy:thanx:
What benefit(s) do expect to derive from the logbook? Whatever it is/they are, that's what should guide the content.
 

ISOsandy

Inactive Registered Visitor
#4
Sandy,

Most of the logbooks I have seen have resembled a simple spreadsheet. They have been very simple: date-activity-description-and signature. More importantly will be what you document in the logbook and archiving it. For example, you may want to document adjustments, flow verification, movement of equipment, weekly cleaning, etc.

but to your question, if you have other logbooks servicing other equipment, do you see any reason not to use it for the clean room? That way you don't have to create a new book just for it. Or, go ahead and make up a simple logbook to use for all your equipment.
That is along the lines of what I was thinking.
We wanted to have a log book for each room, each room having a limited number of equipment, so I figured we could do a "all in one" deal.

Thanks!
 

ISOsandy

Inactive Registered Visitor
#5
What benefit(s) do expect to derive from the logbook? Whatever it is/they are, that's what should guide the content.
I believe the log books are required for the cleanrooms. Have to keep track of in and out and equipment PM's, ect.

I just wasn't sure if putting all of the equipment and room it is in into one log book was realistic.

First attempt at the clean room, so I am learning (or trying to) as fast as I can and as we move along! :mg:
 
A

andygr

#6
As recomended by the others a simple spreadshed type log is all you need.
Typicaly there are shift/daily , weekly, monthly/quarterly checks that are performed to ensure that the room is maintained and verified "clean". If your are working to a spec pick out the "shall" items for the log which is your record of accomplishing the task.

For each task a simple procedure of what is to be done will be the other part of this activity.

The other type of log I have seen used for clean room opperations is one that captures C/A or maintance actions outside those normaly performed. IE room removed from service to repaire ceiling or overhaul ply cutter actions documented.

This can be a seperate log but would recomend that you concider just having it as a sheet that is part of the main log you use ever day. I personely like everthing in one place as it allows for a complete picture of what happened to be seen. A visual display board type cover sheet and any one at a glance can see the status of the cleen room.
 

ISOsandy

Inactive Registered Visitor
#7
Anyone familiar with cleanrooms/controlled environments? I did some quick calculations and wanted an opinion if I am correct in my thinking!

Thanks,
Sandy
 
A

andygr

#8
Sandy
What are the processes performed. There is quite a spread on requirements based on if you are making optics, IC chips or Composite bonding. Also the type of industry.
 

ISOsandy

Inactive Registered Visitor
#9
Sandy
What are the processes performed. There is quite a spread on requirements based on if you are making optics, IC chips or Composite bonding. Also the type of industry.
Correct, however we are going for controlled environment that will be somewhat compliant to ISO Class 8 (100,000). We are not required to be certified and class 8 is pretty open.

We manufacture orthobiological materials for (bone) implantation for the medical industry.
We use equipment for forming (presses), powder mixers, kilns, drying ovens, thermal packaging equipment... those are the big ones.
 
Thread starter Similar threads Forum Replies Date
D ESD cleanroom Manufacturing and Related Processes 4
B Sub-contractor cleanroom monitoring ISO 13485:2016 - Medical Device Quality Management Systems 0
D Cleanroom requirements for surgical apparel EU Medical Device Regulations 2
N Cleanroom Classification Change Other Medical Device Related Standards 7
P Using Zinc Plated Steel in a Cleanroom Other Medical Device Related Standards 3
J Cleanroom Differential Pressure Monitoring, frequent manual observation US Food and Drug Administration (FDA) 6
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
chris1price Cleanroom Monitoring Plan - ISO14644-2:2015 - Risk Assessment Other Medical Device Related Standards 3
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 11
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
J ISO 14644 - Monitoring Clean Room Particulates (Class 8 Cleanroom) Other ISO and International Standards and European Regulations 4
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

Similar threads

Top Bottom