Zeta Machine validation-01

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PREMIER MEDICAL CORPORATION PRIVATE LIMITED, Sarigam – 396 155
PRODUCTION DEPARTMENT
Tile:
Validation of Sealing parameters of Aluminum Pouch by four side Sealing Machine
Name of Product:
First Response ® Malaria Ag. P. falciparum (HRP2) Card Test
Document No.:
VAL-PD-PV-I0118S
A
B
C
D
Page 1 of 11
Study Objective:
The objective of this study is to determine effect of temperature and speed of Four side sealing machine
on sealing integrity of aluminum pouch and set parameters for proper sealing of pouches.
Site of testing:
All testing is performed at the Quality Control Laboratory of Premier Medical Corporation Pvt. Ltd.,
located at A1-302, GIDC, Dist. Valsad, Gujarat, India 396155.
Personnel:
The validation protocols will be prepared, reviewed and authorized by Production, QC and QA
department, respectively. The design prototype will be prepared by production executive in presence of
QC personal. Qualified Quality Control personnel perform all testing and quality control measures to
ensure that the testing is conducted in accordance of good laboratory practices, supervised by the QC
Manager in charge.
Plan of work:
Sampling of Printed First Response ® Malaria Ag. P. falciparum (HRP2) Card Test Aluminum Pouch
will be done based on total aluminum pouch (with test devices and other component) sealed by each
sealing machine in a day is mentioned in below table.
Sampling plan
As per SOP No. OP-QC-27
Sampling Plan
Normal (Single Sampling)
Inspection Level
S-3 with the AQL of 0.65
Approximate pouch sealed by Particular  13700 Nos X 4 Channel  54800
sealing machine
Nos
Sampling Quantity per channel
20 Nos.
1. Issue required raw material from store department for validation i.e. Aluminum pouch roll,
Plastic cassettes, activated desiccants, bring all material to dry room check for cleanliness
before starting validation process.
2. The Four side pouch sealing of aluminum pouches (20 Nos.) each contain 1 test device and 1
Desiccant will be sealed as per specification mentioned in prototype table for four channels of
sealing (20 Pouch X 4=80 Pouch Total) machine.
3. Each channel sealed pouches are labeled with channel number (i.e. 1 to 4) and Pouch number
(1 to 20) with its respective prototype number.
4. Measure Spring tension for front and rear view of spring and surface tension of material for
each channel, keep same spring tension throughout whole validation protocol preparation.
5. All sealed pouches will be submitted to QC department for testing.
6. Note: As all the product have similar pouch material, only a single product’s pouch sealing
validation will be applicable to all the catalogue products.
7. All products have same pouch material roll only printing matter varies.
PREMIER MEDICAL CORPORATION PRIVATE LIMITED, Sarigam – 396 155
PRODUCTION DEPARTMENT
Tile:
Validation of Sealing parameters of Aluminum Pouch by four side Sealing Machine
Name of Product:
First Response ® Malaria Ag. P. falciparum (HRP2) Card Test
Document No.:
VAL-PD-PV-I0118S
Page 2 of 11
Sealing condition
Prototype No.
Temperature
Set
Acceptable
Temp.
Prototype: A1-PP
165 °C
165±2°C
Prototype: B1-PP
170 °C
170±2°C
Prototype: C1-PP
175 °C
175±2°C
Prototype: D1-PP
180 °C
180±2°C
Prototype: E1-PP
185 °C
185±2°C
E
Responsibility
Sr. No.
Activity
1
Validation plan and protocol
preparation
2
Validation Protocol Review
3
Protocol execution
4
Line clearance and approval during
protocol execution.
5
Protocol testing
6
7
Sealing roller
Side sealer top
Side sealer bottom
End sealer top
End sealer bottom
Side sealer top
Side sealer bottom
End sealer top
End sealer bottom
Side sealer top
Side sealer bottom
End sealer top
End sealer bottom
Side sealer top
Side sealer bottom
End sealer top
End sealer bottom
Side sealer top
Side sealer bottom
End sealer top
End sealer bottom
Speed
30 RPM
30 RPM
30 RPM
30 RPM
30 RPM
Sealing
Channel
No.
Sample
Qty.
1
2
3
4
1
2
3
4
1
2
3
4
1
2
3
4
1
2
3
4
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
Department
Designation
Production
Asst. Production Manager
QC
Production
Manager QC
Production Officer/Executive
QA
Officer QA / Executive QA
QC
Officer QC / Executive QC /Asst.
Manager
QA
Manager QA
Validation Protocol testing result
review
Validation Protocol and results
Approval
-
Director
Prepared by
Reviewed by
Approved by
Asst. Manager Production
Manager QC
Manager QA
PREMIER MEDICAL CORPORATION PRIVATE LIMITED, Sarigam – 396 155
PRODUCTION DEPARTMENT
Tile:
Validation of Sealing parameters of Aluminum Pouch by four side Sealing Machine
Name of Product:
First Response ® Malaria Ag. P. falciparum (HRP2) Card Test
Document No.:
VAL-PD-PV-I0118S
F
F1
Production activities
Material used
Name of Product: First Response ® Malaria Ag. P. falciparum (HRP2) Card Test
Sr. No.
Part No.
Description
A.R. No.
1
F2
Page 3 of 11
Qty.
Printed First Response ® Malaria Ag. P.
I13-CAS-001 falciparum (HRP2) Card Test plastic
cassettes
2
(S)PI13POUR-001
3
SIL-001
First Response ® Malaria Ag. P. falciparum
(HRP2) Card Test Pouch Roll.
Desiccant
Equipment used
Sr. No.
1
2
3
4
Equipment
Code.
PMC-PD-E006
PMC-PD-E010
PMC-PD-E017
PMC-QC-E018
Name of Equipment
SOP No.
Hot Air Oven
Four side Sealing Machine
Hygrometer
Vernier Caliper
OP-PD-19
OP-PD-30
OP-PD-16
OP-QC-96
G Production Process:
(G1)
Desiccant activation
List of Equipment’s used
Sr. No.
1
Equipment Code.
PMC-PD-E006
Name of Equipment
Hot Air Oven
SOP No.
OP-PD-19
PRECAUTIONS:
1.
Use Safety Appliances.
2.
Use clean & dry equipment’s & containers.
3.
Use safety Face Mask.
4.
Use heat protective hand gloves.
5.
Keep the desiccant activation area clean.
Sr.
No
Activity
.
Activate Desiccant bags for 2 hours at 92 ± 2
1
°C in Hot Air Oven No.PMC- PD-E006
(Follow SOP No.: OP-PD-19). Record the
activity in Format No. FM-PD-05.
After activation, collect and seal the activated
desiccant bags into containers labelled as
“activated desiccant, AR no. and date of
activation”.
Date
Time
From
To
Done
By
Check.
By
PREMIER MEDICAL CORPORATION PRIVATE LIMITED, Sarigam – 396 155
PRODUCTION DEPARTMENT
Tile:
Validation of Sealing parameters of Aluminum Pouch by four side Sealing Machine
Name of Product:
First Response ® Malaria Ag. P. falciparum (HRP2) Card Test
Document No.:
VAL-PD-PV-I0118S
Page 4 of 11
Line Clearance for Cassettes assembling and four side sealing machine procedure
Date
Cleanliness of
Four side
sealing
machine and
dry room
area.
Time
OK/Not OK
Check Points
Are previous
Are
Lot/ material Temperature
removed from and humidity
the machines
of dry room
and dry
within
room?
specified
limit
%RH and
Yes/No
Temp.
Is proper
status
label on
Dry room
and
equipmen
t
Checked
by
Prod.
Approved
by
QA
Yes/No
(G2) Test device assembling and pouching process with Four side sealing machine
LIST OF EQUIPMENTS USED
Sr. No.
1
2
Equipment Code
PMC-PD-E010
PMC-PD-E017
Name of Equipment
Four Side Sealing Machine
Hygrometer
SOP No.
OP-PD-30
OP-PD-16
PRECAUTIONS:
(1) Use Safety Appliances.
(2) Use clean & dry equipment’s & containers.
(3) Use safety Face Mask.
(4) Use disposable hand gloves.
(5) Keep Reagent away from heat.
(6) Keep the dry room clean.
(7) Carry out the entire Test Devices manufacturing process under control conditions of humidity &
temperature.
(8) Get the line clearance from QA department before starting processing the Steps.
G3
1.
Production process
Spring Tension: During whole validation protocol preparation spring distance for front and rear to be
maintained same as measured in below table.
Front View:
Spring No.
Length(mm)
1
2
3
4
5
6
7
8
Rear View:
Spring No.
Length(mm)
1
2
3
4
5
6
7
8
PREMIER MEDICAL CORPORATION PRIVATE LIMITED, Sarigam – 396 155
PRODUCTION DEPARTMENT
Tile:
Validation of Sealing parameters of Aluminum Pouch by four side Sealing Machine
Name of Product:
First Response ® Malaria Ag. P. falciparum (HRP2) Card Test
Document No.:
VAL-PD-PV-I0118S
Page 5 of 11
Surface Tension: Measure surface tension of aluminum pouch rolls for all four-pouch sealing channel
and record in below table.
2.
1
Channel No.
Surface tension (T)
2
Sr.
Activity Description
No
(G1): Coding of aluminum pouches
1
Label the sealed aluminum pouches with prototype no
A1 to E1 by using permanent marker pen. (20
Pouches/each channel)
2 Prepared individual bunch of pouches for each
prototype and channel after careful review.
Sr.
No.
1
Activity
3
Date
Date
Time
From
To
Time
From
To
4
Done
by
Check
By
Done
By
Check.
By
Get the line clearance from QA department before
starting a process.
2
Assemble plastic cassettes by top and bottom a part
of the plastic Cassette manually by hand.
3
Place one Cassette and one desiccant on moving
conveyor and pass it for sealing under Four side
sealing machine
4
Seal the pouches by using Four side sealing
machine as per prototype given in table following
SOP No.: OP-PD-30. Record Four side sealing
machine temperature in format No.: FM-PD-16.
Attach filled format with validation report.
Equipment ID : (PMC-PD-E010)
Prototype No.
Prototype: A1-PP
Prototype: B1-PP
Prototype: C1-PP
Prototype: D1-PP
Prototype: E1-PP
Time
From
To
Channel
No.
Qty.
1
2
3
4
1
2
3
4
1
2
3
4
1
2
3
4
1
2
3
4
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
20 Nos.
Done By
Check. By
PREMIER MEDICAL CORPORATION PRIVATE LIMITED, Sarigam – 396 155
PRODUCTION DEPARTMENT
Tile:
Validation of Sealing parameters of Aluminum Pouch by four side Sealing Machine
Name of Product:
First Response ® Malaria Ag. P. falciparum (HRP2) Card Test
Document No.:
VAL-PD-PV-I0118S
(H)
Page 6 of 11
Testing protocol
Date of testing
1.
Visually observe all pouches for
1) Sealing integrity i.e channels, kinks, fold, Air pocket or notch in sealing area,
Criteria: “ok” if sealing integrity is ok
“Not ok” if sealing area has any of above mentioned defect.
2) Sealing area of pouch has a burning sign or not.
Criteria: “Pouch damaged” Burned area observed
“Pouch not damaged” No burned observed
2.
Check for Sealing area width of sealed aluminum pouch using Calibrated Vernier caliper (PMC-QCE018; SOP No. OP-QC-96) for each prototype.
Area of each sealed aluminum pouch width will be measured from four site of middle part of sealed
pouch as per below diagram by using calibrated Vernier caliper. (Sealing width must be between 4 mm
to 15mm)
Site 3
Site 1
Site 2
Site 4
3.
Perform leak test (Pressure -400 mmhg) for all pouches by using leak test apparatus for all prototype.
And check for pouch leaked or not leaked (follow SOP No.: OP-QC-75). Visually observe desiccant
quality after leak test and record result of desiccant quality.
Note : Detailed results recorded for each pouch is as per PMC-PD-E010: Annexure A- (Chanel 1), Annexure
B- (Chanel 2) , Annexure C- (Chanel 3) , Annexure D- (Chanel 4)
(I 1) Acceptance Criteria
Proper sealing:
1.1 There must not be any channels, kinks, folds, air pockets or notches or any signs of burning or
melting due to overheating.
1.2 Sealing width must be between 4 mm to 15mm.
1.3 Pouch should not show any leakage during leak test.
1.4 Pouch should not be damaged.
1.5 Desiccant should not be moist.
(I 2) Method of Data Analysis
Data analysis done based on above mentioned criteria.
PREMIER MEDICAL CORPORATION PRIVATE LIMITED, Sarigam – 396 155
PRODUCTION DEPARTMENT
Tile:
Validation of Sealing parameters of Aluminum Pouch by four side Sealing Machine
Name of Product:
First Response ® Malaria Ag. P. falciparum (HRP2) Card Test
Document No.:
VAL-PD-PV-I0118S
Page 7 of 11
(J) Observation (Channel 1)
Sr.
No.
Prototype
No.
1
A1-PP
2
B1-PP
3
C1-PP
4
D1-PP
5
E1-PP
Criteria
Number
of
Pouches
sealed
Sealing integrity
(In numbers)
Ok
Not Ok
Number of pouches sealing
Area have burnt
(In numbers)
Damaged
No pouch
having
leakage
(0%
Leakage)
Note: Detailed results recorded for each pouch is as per PMC-PD-E010: Annexure A
Not
Damaged
Sealed
Area
Width
(Average)
Pouch having leakage
(In numbers)
Leakage
No
Leakage
Desiccant Quality
(In numbers)
% of
leakage
Ok
Not Ok
PREMIER MEDICAL CORPORATION PRIVATE LIMITED, Sarigam – 396 155
PRODUCTION DEPARTMENT
Tile:
Validation of Sealing parameters of Aluminum Pouch by four side Sealing Machine
Name of Product:
First Response ® Malaria Ag. P. falciparum (HRP2) Card Test
Document No.:
VAL-PD-PV-I0118S
Page 8 of 11
(J) Observation (Channel 2)
Sr.
No.
Prototype
No.
1
A1-PP
2
B1-PP
3
C1-PP
4
D1-PP
5
E1-PP
Criteria
Number
of
Pouches
sealed
Sealing integrity
(In numbers)
Ok
Not Ok
Number of pouches sealing
Area have burnt
(In numbers)
Damaged
No pouch
having
leakage
(0%
Leakage)
Note: Detailed results recorded for each pouch is as per PMC-PD-E010: Annexure B
Not
Damaged
Sealed
Area
Width
(Average)
Pouch having leakage
(In numbers)
Leakage
No
Leakage
Desiccant Quality
(In numbers)
% of
leakage
Ok
Not Ok
PREMIER MEDICAL CORPORATION PRIVATE LIMITED, Sarigam – 396 155
PRODUCTION DEPARTMENT
Tile:
Validation of Sealing parameters of Aluminum Pouch by four side Sealing Machine
Name of Product:
First Response ® Malaria Ag. P. falciparum (HRP2) Card Test
Document No.:
VAL-PD-PV-I0118S
Page 9 of 11
(J) Observation (Channel 3)
Sr.
No.
Prototype
No.
1
A1-PP
2
B1-PP
3
C1-PP
4
D1-PP
5
E1-PP
Criteria
Number
of
Pouches
sealed
Sealing integrity
(In numbers)
Ok
Not Ok
Number of pouches sealing
Area have burnt
(In numbers)
Damaged
No pouch
having
leakage
(0%
Leakage)
Note: Detailed results recorded for each pouch is as per PMC-PD-E010: Annexure C
Not
Damaged
Sealed
Area
Width
(Average)
Pouch having leakage
(In numbers)
Leakage
No
Leakage
Desiccant Quality
(In numbers)
% of
leakage
Ok
Not Ok
PREMIER MEDICAL CORPORATION PRIVATE LIMITED, Sarigam – 396 155
PRODUCTION DEPARTMENT
Tile:
Validation of Sealing parameters of Aluminum Pouch by four side Sealing Machine
Name of Product:
First Response ® Malaria Ag. P. falciparum (HRP2) Card Test
Document No.:
VAL-PD-PV-I0118S
Page 10 of 11
(J) Observation (Channel 4)
Sr.
No.
Prototype
No.
1
A1-PP
2
B1-PP
3
C1-PP
4
D1-PP
5
E1-PP
Criteria
Number
of
Pouches
sealed
Sealing integrity
(In numbers)
Ok
Not Ok
Number of pouches sealing
Area have burnt
(In numbers)
Damaged
No pouch
having
leakage
(0%
Leakage)
Note: Detailed results recorded for each pouch is as per PMC-PD-E010: Annexure D
Not
Damaged
Sealed
Area
Width
(Average)
Pouch having leakage
(In numbers)
Leakage
No
Leakage
Desiccant Quality
(In numbers)
% of
leakage
Ok
Not Ok
PREMIER MEDICAL CORPORATION PRIVATE LIMITED, Sarigam – 396 155
PRODUCTION DEPARTMENT
Tile:
Validation of Sealing parameters of Aluminum Pouch by four side Sealing Machine
Name of Product:
First Response ® Malaria Ag. P. falciparum (HRP2) Card Test
Document No.:
VAL-PD-PV-I0118S
(L)
Page 11 of 11
Study Conclusion :
Tested by
Observed By
Reviewed by
Approved by
QC Officer / QC Executive
Manager QC
Manager QA
Director
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