PURE & CURE HEALTHCARE PVT. LTD.

HARIDWAR
PRODUCTION
RESTRICTED
CIRCULATION
STANDARD OPERATING PROCEDURE
Title : Monitoring of Temperature, Relative Humidity & Differential Pressure In Production Area of
L-Block
SOP No.: HPF/060 Department : PF
Effective Date :
Revision No.: 02 Revision Date :
Supersede Revision No.: 01 Page No.: 1 of 16

1.0 OBJECTIVE:

To lay down a Procedure for Monitoring of Temperature, Relative Humidity & Differential Pressure in
the Production area of L-Block.

2.0 SCOPE:
This SOP is applicable for Monitoring of Temperature, Relative Humidity & Differential Pressure in
Production area and aseptic area of L- Block at Pure & Cure Healthcare Pvt. Ltd., Haridwar.

3.0 RESPONSIBILITY:-

Officer / Executive – Production

4.0 ACCOUNTABILITY:
Head – Production
5.0 ABBREVIATIONS:
0
C Degree Celsius
Hrs Hour
HVAC Heating Ventilation and Air Conditioner
Ltd. Limited
NMT Not More Than
Pvt Private
RH Relative Humidity
RM Raw Material
SOP Standard Operating Procedure
ΔP Differential Pressure
CIP Clean In Place
SIP Sterilization In Place.
DTR Digital Differential Pressure + Temperature + Relative humidity
No. Number
Sign Signature.

Prepared By Reviewed By Approved By Authorized By

Operating Officer / Operating Manager Department Head Head QA
Executive
Sign
Date
Name
FORMAT NO.: QAH-119/F01-02
 PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
RESTRICTED
CIRCULATION
STANDARD OPERATING PROCEDURE
Title : Monitoring of Temperature, Relative Humidity & Differential Pressure In Production Area of
L-Block
SOP No.: HPF/060 Department : PF
Effective Date :
Revision No.: 02 Revision Date :
Supersede Revision No.: 01 Page No.: 2 of 16

6.0 PROCEDURE:
6.1 PRECAUTIONS AND ACCEPTANCE CRITERIA:
6.1.1 Ensure that the digital Differential Pressure, Temperature and Relative humidity
gauzes (DTR & DPG Gauzes) of Radix, digital hygrometer & other monitoring devices shall be
calibrated.

6.1.2 Ensure that the digital hygrometer and other temperature monitoring devices shall
be placed at
hot spot (if available).

6.1.3 Temperature, Relative Humidity and Differential Pressure of respective areas shall
be recorded initially and at frequency of 4 hrs. ± 30 min. or after any breakdown.

6.1.4 During operation, Monitoring of Temperature, Relative Humidity and Differential

Pressure shall be recorded as per respective BMR for area specific along with log books.

6.1.5 In case of material storage minimum and maximum temperature shall be check of
previous 24 hrs.
at the start of shift by pressing min /max key of respective digital hygrometer and recoding in
respective Annexure’s.

Note: Reset the Digital Hygrometer after taking the minimum and maximum temperature by long
press of memory button given in digital hygrometer.

6.1.6 During periodic calibration of digital hygrometer use other calibrated digital
hygrometer kept as stand by and records their ID in the remark column.

6.1.7 After receiving of digital hygrometer and other monitoring devises from outside/
calibration agency, previous memory shall be reset before use.

6.2 TEMPERATURE & RELATIVE HUMIDITY MONITORING:

Prepared By Reviewed By Approved By Authorized By

Operating Officer / Operating Manager Department Head Head QA
Executive
Sign
Date
Name
FORMAT NO.: QAH-119/F01-02
 PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
RESTRICTED
CIRCULATION
STANDARD OPERATING PROCEDURE
Title : Monitoring of Temperature, Relative Humidity & Differential Pressure In Production Area of
L-Block
SOP No.: HPF/060 Department : PF
Effective Date :
Revision No.: 02 Revision Date :
Supersede Revision No.: 01 Page No.: 3 of 16

6.2.1 Observe the reading on the LED Display / Digital Display (DTR Gauzes) of
Radix/ Digital Hygrometer / Other monitoring devices / Data logger installed in the area.
6.2.2 Record the Temperature and Relative Humidity details of the area in respective
Annexure’s.

6.2.2.1 During operation temperature may excurse upto 27°C of following areas:
 Unit Preparation Room (Autoclave Loading / Unloading side)
 Manufacturing Room (CIP/SIP & Water collection, During Batch Manufacturing)
 Filtration Room (CIP/SIP).
 Filling room (CIP/SIP).

6.2.2.2 Handling of Excursions:

6.2.2.2.1 During filling and sealing if excursion is observed out of

specified limit related to temperature, Relative humidity and differential pressure then follow
the below action:

6.2.2.2.1.1 Clear the filling & sealing track and stop the filling & sealin
operation.

1.1.1.1.1.1 Inform to engineering department for rectification of observe

excursion.

6.2.2.2.1.2 Wait for 15 min to resume the observed excursion if not rectified raise the Break down slip
/ SAP, along with incident for further action plan & CAPA.

6.2.2.2.1.3 Record the intervention detail in the respective BMR / Log shee

6.2.2.2.1.4 If any monitoring devise not working , then follow the below
action:

Prepared By Reviewed By Approved By Authorized By

Operating Officer / Operating Manager Department Head Head QA
Executive
Sign
Date
Name
FORMAT NO.: QAH-119/F01-02
 PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
RESTRICTED
CIRCULATION
STANDARD OPERATING PROCEDURE
Title : Monitoring of Temperature, Relative Humidity & Differential Pressure In Production Area of
L-Block
SOP No.: HPF/060 Department : PF
Effective Date :
Revision No.: 02 Revision Date :
Supersede Revision No.: 01 Page No.: 4 of 16

6.2.2.2.1.4.1 Inform to engineering department for rectification o

same.

6.2.2.2.1.4.2 If defected monitoring devise will not recoverabl

initiate the change control for new
devise along with calibration & ID.

6.2.2.2.1.4.3 New addition / deletion of monitoring devise shall b

handled through SOP No.:
QAH/008.

Monitoring Frequency: Initially &

at frequency of 4 hrs. ± 30 min. and Annexure
S. No. Area as per respective BMR in operation Reference
for recording
Temperature %RH
Filling Room -01
Filling Room -02
Filtration Room -01
01 Filtration Room -02 NMT 25°C NMT 60% ANNEXURE-I
Disinfectant filtration Room
Machine Tool Room
Cooling zone
Unit Preparation Area
Manufacturing Room -01
Manufacturing Room -02 NMT 25°C NMT 60% ANNEXURE-II

02 Granule Day store

RM Day Store NMT 25°C ANNEXURE-II
NA
Disinfectant Preparation room

Packing Area NMT 25°C NA ANNEXURE-VI

Prepared By Reviewed By Approved By Authorized By
Operating Officer / Operating Manager Department Head Head QA
Executive
Sign
Date
Name
FORMAT NO.: QAH-119/F01-02
 PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
RESTRICTED
CIRCULATION
STANDARD OPERATING PROCEDURE
Title : Monitoring of Temperature, Relative Humidity & Differential Pressure In Production Area of
L-Block
SOP No.: HPF/060 Department : PF
Effective Date :
Revision No.: 02 Revision Date :
Supersede Revision No.: 01 Page No.: 5 of 16

FG Quarantine
03 Unloading Area NMT 25°C

6.3 DIFFERENTIAL PRESSURE:

6.3.1 Ensure that Maganhelic Gauges are calibrated.
6.3.2 Differential Pressure shall be monitored of all areas, where Magnehellic gauges /
DTR displays are installed.
6.3.3 Differential Pressure of concern Area shall be monitored by Officer / Executive concern area,
and record shall be maintained as per concern Annexure.

6.3.4 Differential Pressure of respective areas shall be recorded initially, at every 4 Hours ±30 min.

6.3.5 Whenever out of limit results are observed, immediate inform to engineering department for
corrective action. If differential pressure of classified area, return to it’s, define limit, within 15
minutes, then record physical parameter as per defined interval.

6.3.6 In case physical parameter not in limit for more than 15 min. concern dept. shall fill the
incident report and inform to Engineering department through breakdown intimation Slip /
SAP procedure.

Note: 1. In case of Holidays / Non-Working Days / if there is no Activity , Temperature and Relative
Humidity will not be recorded in the respective Annexure of the L-Block
Production.

2. In case any activities performed on Holidays / Non-Working Days, Temperature and

Relative Humidity shall be recorded in the respective Annexure of L-Block Production.

7.0 ANNEXURES:
ANNEXURE No. TITLE OF ANNEXURE FORMAT No.
Temperature & Relative Humidity record (NMT
Annexure – I 25°C, HPF-060/F01-02
NMT 60 % )
Prepared By Reviewed By Approved By Authorized By
Operating Officer / Operating Manager Department Head Head QA
Executive
Sign
Date
Name
FORMAT NO.: QAH-119/F01-02
 PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
RESTRICTED
CIRCULATION
STANDARD OPERATING PROCEDURE
Title : Monitoring of Temperature, Relative Humidity & Differential Pressure In Production Area of
L-Block
SOP No.: HPF/060 Department : PF
Effective Date :
Revision No.: 02 Revision Date :
Supersede Revision No.: 01 Page No.: 6 of 16

Annexure- II Differential Pressure Record (Production L-Block

HPF-060/F02-02
(Filling & Holding Area)
Annexure- III
Differential Pressure Record Production Area-I HPF-060/F03-02
Annexure- IV
Differential Pressure Record Production Area-II HPF-060/F04-01
Temperature & Relative Humidity record (NMT
Annexure – V 25°C, HPF-060/F05-00
NMT 60 % )
Annexure- VI HPF-060/F06-00
Temperature Record (LVP, PACKING)
ENCLOSURES: SOP Training Record.
8.0 DISTRIBUTION:
 Controlled Copy No. 01 Quality Assurance
 Controlled Copy No. 02 Production
 Master Copy Quality Assurance

9.0 REFERENCES:
Not Applicable
10.0 REVISION HISTORY:
CHANGE HISTORY LOG
Revision Change Reason for Effective Updated
Details of Changes
No. Control No. Change Date By
01 CC/H-L/  Annexure-I, II &III To enhance the 04/05/19 Abdul
PROD/19/ revised to add the existing Raziq
0008 Frequency of procedures.
Temperature, RH &
Differential pressure
recording at every 4
Hours ± 30 min.
 DP recording for
return A/L-I added in
annexure –II
Prepared By Reviewed By Approved By Authorized By
Operating Officer / Operating Manager Department Head Head QA
Executive
Sign
Date
Name
FORMAT NO.: QAH-119/F01-02
 PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
RESTRICTED
CIRCULATION
STANDARD OPERATING PROCEDURE
Title : Monitoring of Temperature, Relative Humidity & Differential Pressure In Production Area of
L-Block
SOP No.: HPF/060 Department : PF
Effective Date :
Revision No.: 02 Revision Date :
Supersede Revision No.: 01 Page No.: 7 of 16

 DP recording for
Mfg.1-A/L-II, Mfg.2-
A/L-II, added in
annexure –III.
 Procedure for temp.
Excursion handling
defines at point no.
6.3.5.
 Annexure III split in
two part Annexure –
III, & IV.
 Differential pressure
recording for aseptic
corridor with respect
to A/L-III added.
02 CC/H-  New Abbreviations  For better
L/PROD/20/ included in the understandin Dheeraj
0021 proposed change. g and Pal
enhance the Baghel
procedure.
 In the step 6.2, the
procedure for the  To enhance
acceptance criteria the procedure
mentioned from steps for the better
6.1.1 to 6.1.7. compliance.

 In the proposed step

6.2 temperatures and  For the better
relative Humidity compliance
monitoring shall be and
done through various understandin
instruments and also g the
handling of monitoring
excursions is system of
mentioned in the step Building
6.2.2.2 along with management
Prepared By Reviewed By Approved By Authorized By
Operating Officer / Operating Manager Department Head Head QA
Executive
Sign
Date
Name
FORMAT NO.: QAH-119/F01-02
 PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
RESTRICTED
CIRCULATION
STANDARD OPERATING PROCEDURE
Title : Monitoring of Temperature, Relative Humidity & Differential Pressure In Production Area of
L-Block
SOP No.: HPF/060 Department : PF
Effective Date :
Revision No.: 02 Revision Date :
Supersede Revision No.: 01 Page No.: 8 of 16

Temperature and
relative humidity limit
and monitoring
frequency is given of
different areas.
system
(BMS).
 In the proposed step
6.3.2 the monitoring
instruments of RH
and Humidity are
mentioned.
 For better
understandin
 In the proposed step
g and better
6.3.6 in case of
compliance.
physical parameters
are not in the limit for
15 minutes inform to
 For better
the engineering
compliance
department through
and to
the breakdown
enhance the
intimation slip/SAP
SOP.
procedure.
 In the proposed step
6.3.6 In case of
Holidays / Non-
Working Days / if
 For the better
there is no Activity,
understandin
Temperature and
g and better
Relative Humidity
compliance.
will not be recorded
in the respective
Annexure of the L-
Block Production.
 Annexure V & VI to
be incorporated.
CC/H- Akums logo has been To make
Prepared By Reviewed By Approved By Authorized By
Operating Officer / Operating Manager Department Head Head QA
Executive
Sign
Date
Name
FORMAT NO.: QAH-119/F01-02
 PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
RESTRICTED
CIRCULATION
STANDARD OPERATING PROCEDURE
Title : Monitoring of Temperature, Relative Humidity & Differential Pressure In Production Area of
L-Block
SOP No.: HPF/060 Department : PF
Effective Date :
Revision No.: 02 Revision Date :
Supersede Revision No.: 01 Page No.: 9 of 16

individual
G/QA/19/
removed identity of Pure
0862
& Cure

Prepared By Reviewed By Approved By Authorized By

Operating Officer / Operating Manager Department Head Head QA
Executive
Sign
Date
Name
FORMAT NO.: QAH-119/F01-02
 PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
RESTRICTED CIRCULATION
STANDARD OPERATING PROCEDURE
Title : Monitoring of Temperature, Relative Humidity & Differential Pressure In Production Area of L-Block
Department : PF
SOP No.: HPF/060
Effective Date :
Revision No.: 02 Revision Date :
Supersede Revision No.: 01 Page No.: 10 of 16

ANNEXURE-I
PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
TEMPERATURE & RELATIVE HUMIDITY RECORD (NMT 25°C, NMT 60 %)
Block: L Block Month: …………...……
Limits: Temperature: NMT 25°C Relative Humidity: NMT 60%

Area
Filling Room- Filtration Room- Disinfectant
Filling Room-01 Filtration Room-01 Machine Tool Room Cooling zone
Dat 02 02 filtration Room Verified
Checked By
e By QA
Temp. RH Temp. RH Temp. RH Temp. RH Temp. RH Temp. RH Temp. RH
Time

Frequency: Every 4 Hours ± 30 min.

FORMAT No. : HPF-060/F01-02 Page X of Y
Prepared By Reviewed By Approved By Authorized By
Operating Officer / Executive Operating Manager Department Head Head QA
Sign
Date
Name
FORMAT NO. : QAH-119/F01-02
 PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
RESTRICTED CIRCULATION
STANDARD OPERATING PROCEDURE
Title : Monitoring of Temperature, Relative Humidity & Differential Pressure In Production Area of L-Block
Department : PF
SOP No.: HPF/060
Effective Date :
Revision No.: 02 Revision Date :
Supersede Revision No.: 01 Page No.: 11 of 16

ANNEXURE-II
PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
DIFFERENTIAL PRESSURE RECORD (PRODUCTION L-BLOCK (FILLING & HOLDING AREA)
Block: ………………… Month: ……………
Area Entry Disinfect Return Return
Entry Entry A/L-III- Filling Filling Return
A/L-I Machine Filtration Filtration Cool -ant Air- A/L- III
Air- Air- Aseptic Room- Room- Air-
Dat Aseptic Tool Room-I Room- II Zone filtration lock -II with Checked Verified
lock II lock III corridor I II lock-III
e area Room (05-15 (05-15 (05-15 Room (05 - corridor By By QA
(15-30 (15-30 (05-15 (05-15 (05-15 (15-30
(05-15 (05-15 Pascal) Pascal) Pascal) 05-15 15 (05-15)
Pascal) Pascal) Pascal) Pascal) Pascal) Pascal)
Time Pascal) Pascal) Pascal) Pascal) Pascal

Frequency: Every 4 Hours ± 30 min.

FORMAT No. : HPF-060/F02-02 Page X of Y

Prepared By Reviewed By Approved By Authorized By

Operating Officer / Executive Operating Manager Department Head Head QA
Sign
Date
Name
FORMAT NO. : QAH-119/F01-02
 PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
RESTRICTED CIRCULATION
STANDARD OPERATING PROCEDURE
Title : Monitoring of Temperature, Relative Humidity & Differential Pressure In Production Area of L-Block
Department : PF
SOP No.: HPF/060
Effective Date :
Revision No.: 02 Revision Date :
Supersede Revision No.: 01 Page No.: 12 of 16

ANNEXURE-III
PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
DIFFERENTIAL PRESSURE RECORD OF PRODUCTION AREA -I
Block: ………………… Month: ……………
Area
Unit
PAL-1 PAL-02 PAL-01 Mfg.- 02 PAL-01 PAL-02 Prep. & Garment Equip.
PAL-02
Mfg. -01 Mfg. -01 Mfg.- 01 Mfg.- 02 Room Garment Unit Prep. Sterilizat Washing Washing Checked Verified
Date Mfg.-02
(05 - 15 (15- 30 Room (05 -15 (05- 15 washing (15 -30 ion (05 -15 (05- 15 By By QA
(15 -30
Pascal) Pascal) 05- 15 Pascal Pascal) (05-15 Pascal (05-15 Pascal) Pascal)
Pascal
Time Pascal) Pascal)

Frequency: Every 4 Hours ± 30 min.

Prepared By Reviewed By Approved By Authorized By

Operating Officer / Executive Operating Manager Department Head Head QA
Sign
Date
Name
FORMAT NO. : QAH-119/F01-02
 PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
RESTRICTED CIRCULATION
STANDARD OPERATING PROCEDURE
Title : Monitoring of Temperature, Relative Humidity & Differential Pressure In Production Area of L-Block
Department : PF
SOP No.: HPF/060
Effective Date :
Revision No.: 02 Revision Date :
Supersede Revision No.: 01 Page No.: 13 of 16

FORMAT No. : HPF-060/F03-02 Page X of Y

Prepared By Reviewed By Approved By Authorized By

Operating Officer / Executive Operating Manager Department Head Head QA
Sign
Date
Name
FORMAT NO. : QAH-119/F01-02
 PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
RESTRICTED CIRCULATION
STANDARD OPERATING PROCEDURE
Title : Monitoring of Temperature, Relative Humidity & Differential Pressure In Production Area of L-Block
Department : PF
SOP No.: HPF/060
Effective Date :
Revision No.: 02 Revision Date :
Supersede Revision No.: 01 Page No.: 14 of 16

ANNEXURE-IV
PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
DIFFERENTIAL PRESSURE RECORD OF PRODUCTION AREA -II
Block: ………………… Month: ……………
Area PAL-01 PAL Buffer
PAL-01 Disinfectant. Granule Production Primary
Raw Granul PAL-01 Buffer Room
Disinfectant Prep. Feeding Accessory Change
material e scrap out Room to Grade D Checked Verified
Date preparation Room room Room Room- 02
store feeding (05- 15 (05 - 15 corridor By By QA
(05 -15 (15- 30 (05- 15 (05- 15 (15- 30
(05- 15 (05 -15 Pascal) Pascal) (05 - 15
Pascal) Pascal) Pascal) Pascal) Pascal)
Time Pascal) Pascal) Pascal)

Frequency: Every 4 Hours ± 30 min.

FORMAT No.: HPF-060/F04-01 Page X of Y

Prepared By Reviewed By Approved By Authorized By

Operating Officer / Executive Operating Manager Department Head Head QA
Sign
Date
Name
FORMAT NO. : QAH-119/F01-02
 PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
RESTRICTED CIRCULATION
STANDARD OPERATING PROCEDURE
Title : Monitoring of Temperature, Relative Humidity & Differential Pressure In Production Area of L-Block
Department : PF
SOP No.: HPF/060
Effective Date :
Revision No.: 02 Revision Date :
Supersede Revision No.: 01 Page No.: 15 of 16

ANNEXURE-V
PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
TEMPERATURE & RELATIVE HUMIDITY RECORD (NMT 25°C, NMT 60 %)
Block: L Block Month: …………...……
Limits: Temperature: NMT 25°C Relative Humidity: NMT 60%

Area
Manufacturing Room Manufacturing Disinfectant
Unit Preparation Area Granule Day store RM Day Store
-01 Room -02 Preparation Room
Verified By
Date Checked By
QA
RH
Temp.
Time Temp. RH Temp. RH Temp. RH Temp RH Temp. RH

Frequency: Every 4 Hours ± 30 min.

FORMAT No. : HPF-060/F05-00 Page X of Y
Prepared By Reviewed By Approved By Authorized By
Operating Officer / Executive Operating Manager Department Head Head QA
Sign
Date
Name
FORMAT NO. : QAH-119/F01-02
 PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
RESTRICTED CIRCULATION
STANDARD OPERATING PROCEDURE
Title : Monitoring of Temperature, Relative Humidity & Differential Pressure In Production Area of L-Block
Department : PF
SOP No.: HPF/060
Effective Date :
Revision No.: 02 Revision Date :
Supersede Revision No.: 01 Page No.: 16 of 16

ANNEXURE-VI
PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
PRODUCTION
TEMPERATURE RECORD (LVP, PACKING)
Block: L Block Month: …………...……
Limits: Temperature: NMT 25°C

Area
Un-Loading Area Packing Area Day FG Store

Date Checked By Verified By

Temperature (ºC) Temperature (ºC) Temperature (ºC)
Time

Frequency: Every 4 Hours ± 30 min.

FORMAT No. : HPF-060/F06-00 Page X of Y
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Operating Officer / Executive Operating Manager Department Head Head QA
Sign
Date
Name
FORMAT NO. : QAH-119/F01-02