 |
| Dehumidifier |
Standard Operating Procedure for portable
dehumidifiers also known as vertical or petal dehumidifiers.
1.0 Purpose
The purpose of this
SOP is to develop a standard procedure for operating the Dehumidifier.
2.0 Scope
This SOP is applicable
for the portable dehumidifiers used in the mixing, granulation, compression, or
encapsulation area of the production section.
3.0 Responsibility
3.1 Machine Operator
is responsible for operating the Dehumidifier.
3.2 Production
Pharmacist is responsible for the implementation of this SOP.
3.3 The HOP is
responsible for ensuring the implementation of the current SOP.
3.4 Q.A. Officer
monitors the compliance of this SOP.
4.0 Procedure
4.1 Relevant area
Pharmacist shall ensure that the fans, filters, and body of the dehumidifier
are properly cleaned according to the standard cleaning procedure and the
water-receiving container or tray is empty.
4.2 Pharmacist shall
ensure that the dehumidifier & the area is labeled with product-related
labels
4.3 After ensuring the
cleaning of the dehumidifier & checking the filters of the dehumidifier,
take line clearance from the Quality Assurance officer.
4.4 After line
clearance, insert the wire plug of the portable dehumidifier in the wall-mounted
socket & press the On button.
4.5 After pressing the
On button it will start working & at the end of the operation press the Off
button, remove the wire & discard the water collected in the container or
tray of the dehumidifier.
4.6 Attach 'To be cleaned
label' and record the activity in the logbook of the Dehumidifier.
5.0 Abbreviations
5.1 SOP: Standard
Operating Procedure
5.2 BMR: Batch
Manufacturing Record
5.3 QA: Quality
Assurance
5.4 HOP:Head Of
Production.
Note
Portable dehumidifiers
are used to control the relative humidity in the areas where it is not
controlled by the HVAC means where the humidity control system is not installed
in the AHU. Currently, the use of portable dehumidifiers is not encouraged in
the pharmaceutical industries rather it must be controlled by the HVAC system.
0 Comments