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Clean Room Logbook

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louay
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369 views

Clean Room Logbook

Uploaded by

louay
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Clean Room Cleaning Logbook

Logbook No:
See SOP/WI, Complete and Review Logbooks, for logbook
maintenance instructions.
While in use store this logbook:
Near the equipment
In the equipment file
This equipment is used during:
Medical device production
API/drug production
Non-production only
Notes:
The normal operational pressure differential should be between
0.05 and 0.08 inches of water column and can be obtained with
fan speed adjustments. Filter inspections are recommended
when differential pressure falls below 0.025 inches of water
column.
Clean Room Cleaning Logbook

Room PN-ID:

Room description: ISO 8 controlled environment

Room location:

PM Frequency

Calibration Frequency

Work Procedure PNs

Room additional details:

(Consider including information


such as: MFG, Model, Serial number,
or a list of individual equipment IDs
that are grouped under this PNID)

Date issued:

Date returned:
Clean Room Cleaning Logbook

Date Initials Activity Room Description, Comments, or Attachments


Code* Differential Pressure (Note page number for chart when documenting chart change)
(0.02 – 0.08, contact maint. < 0.05)

*Activity Codes IQ.........Qualification (includes DQ/IQ/OQ/PQ)


BP...........Batch production (typical use) PM.......Planned maintenance (other than CL/ST)
CA...........Calibration ST........Sterilizing
CL............Cleaning (planned or unplanned) UM......Unplanned maintenance and repair

Reviewed by Date

Room PN-ID:
Clean Room Cleaning Logbook

Cleaning/Sanitizing Agent Preparation


Type: Amount of Initials Verified Date Vacuumed Ceiling Non-Glass Glass Surfaces Floors Trash
Agent (mL) / Date Initials Walls Surfaces Cleaned with Mopped Collected
L=LpHse® / Date Mopped Cleaned
S=SporKlenz Diluted to Sterile filtered
® Total 70% IPA
I=Sterile Volume (L)
filterd 70%
IPA
(circle type) mL / L Initials Initials Initials Initials Initials
Agent: L S I Initials:
Lot: Lot:
Expiry: Expiry:
Agent: L S I Initials:
Lot: Lot:
Expiry: Expiry:
Agent: L S I Initials:
Lot: Lot:
Expiry: Expiry:
Agent: L S I Initials:
Lot: Lot:
Expiry: Expiry:
Agent: L S I Initials:
Lot: Lot:
Expiry: Expiry:

Reviewed by Date
Clean Room Logbook

Room PN-ID:

Insert Completed Chart Here

Reviewed by Date

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