1.0 Purpose
1.1 To define a standard operating and cleaning procedure of Tray Dryer.
2.0 Scope
2.1 This procedure is applicable for Tray Dryer in liquid production area of “NAME” Pharmaceuticals Ltd.
3.0 Responsibility
3.1. Only trained operator is responsible for normal operation. He/ She inform the supervisor about any
deviation from normal operation. He also maintains logbook.
3.2. Sr. Officer- Production/Officer-
Production is responsible for monitoring day to day activity.
4.0 Abbreviations and Definitions
4.1 None
5.0 Materials and Equipment
5.1 None
6.0 Precaution / Health and Safety Considerations
6.1 Don’t press electric switch with wet hand.
6.2 Ensure the surrounding areas are cleaned before starting operation.
6.3 Ventilator or outlet should be never completely closed without attendant.
6.4 While loading, care should be taken that material is not spilled in chamber or on the fan and heater.
6.5 After completion of cycle, the door should be open at lower temperature to avoid high temperature air draft. And even
if it is opened at high temperature, supply should be put off.
6.6 Ensure proper earthing of the Tray Dryer.
7.0 Procedure
7.1 Operation
Procedure
7.1.1 Before operating the Tray Dryer, ensure
that it is clean.
7.1.2 Ensure that main switch is OFF.
7.1.3 After washing the bottle, arrange them on
the tray and keep the tray on the trolley.
7.1.4 After full filling the trolley, insert it
into the dryer and close the door properly and secure tightly.
7.1.5 Now switch “ON” the heater.
7.1.6 When temperature rise at 80⁰ C
(or as per required temperature), start counting the time up to 3 hours (for glass bottles).
7.1.7 Now switch “OFF” the heater and “ON” the
blower up to another 1 Hour.
7.1.8 Then switch “OFF” the blower and the
bottles allowed to cool for some times.
7.1.9 After some times, take out the bottles for
moisture test by Production Officer and QA Officer
and if it is found Ok, then use these bottles for powder filling operation.
7.2 Cleaning
Procedure:
7.2.1 Switch OFF the electrical mains switch of
Bottle / Tray Dryer.
7.2.2 Affix “To Be Cleaned” Label.
7.2.3 Remove the dust from the body with a dry
duster.
7.2.4 Open the door. Remove all trays and take it
in washing area.
7.2.5 Clean each tray by using potable water and
detergent solution, 0.4 % w/v sodium lauryl sulphate
(if required) using nylon scrubber.
7.2.6 Clean each tray with potable water and
finally with purified water.
7.2.7 Remove water with help of clean dry
lint-free cloth.
7.2.8 Keep the tray on trolley and cover with clean cloth or tray dryer.
7.2.9 Machine operator / worker will request Production Officer and QA Officer for checking visual inspection.
7.2.10 At first Production Officer will check the tray
dryer and its surroundings, and then QA Officer will check the tray dryer and its surroundings. If it found
satisfactory result, then he / she will issue
“Cleaned” label.
7.2.11 Record in tray dryer logbook and attach the
label of “Cleaned” in vessel.
7.2.12 After
cleaning the tray dryer if it remains without operation for next 72 hour, will
undergo Re-cleaning operation.
8.0 Reference Document
8.1 In House
9.0 Annexure
9.1 Annexure- I : Format of Machine Logbook
10.0 Revision History
|
Revision
No. |
Brief reason for the revision |
Effective Date |
Remarks |
|
01 |
New |
|
|
11.0 Training
11.1 Head
of Production or his nominee give the training of production operator and
worker.
