1.
SCOPE:
This protocol is
applicable for the cycle development study of tunnel with applicable containers
in manufacturing area.
2.
OBJECTIVE:
The
objective of this protocol is to develop the process parameters for the tunnel
with applicable containers.
3.
ABBREVIATIONS:
·
ID No. - Identification Number
·
NA - Not Applicable
·
OQ - Operational Qualification
·
PQ - Performance Qualification
·
QA - Quality Assurance
·
PN - Production
4.
RESPONSIBILITY:
|
Department/
Function |
Responsibility |
|
Validation group |
Preparation of protocol, compilation and
review of study report. |
|
Validation agency |
Execution of the development study activity and data review |
|
Engineering /
Instrumentation |
Review the protocol/report and provide
required technical support for execution. |
|
User department |
Review the protocol/report including
execution of activity. |
|
Quality Assurance |
Compilation, review and approval of
protocol and report, including participation in the execution, where ever
applicable. |
5.
INTENDED USE OF EQUIPMENT
Tunnel is used for the preparation/processing (depyrogenation) of
containers for the filling of sterile drug product. Depyrogenation process
shall be done by using filtered dry hot air.
6.
SAFETY PRECAUTIONS:
·
Personnel
involved in autoclave qualification shall follow proper written procedures for
equipment operation.
·
Personnel
shall wear necessary gloves, wherever applicable.
·
Do not
touch the hot surfaces during validation.
·
Care should
be taken while handling with electrical cables.
7.
INSTRUMENT/ MATERIALS REQUIRED :
7.1.
Record
the instruments details in annexure-I.
8.
STUDY REQUIREMENTS & OBSERVATIONS:
8.1.
Measurement
of airflow velocity:
8.1.1.
Procedure
·
Switch on
the tunnel fans in maintenance mode.
·
The tunnel
should be stabilized at least 15 min prior to start the activity and
heaters should be OFF.
·
Perform the
air velocity measurement test as per SOP # FU4-QA-GEN-040 and record the
observations in annexure-I.
·
Calculate
minimum, maximum & average velocity of all locations.
Diagram.1 Air velocity sampling locations of filter
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