MFR Double 350 ML CPDA - 150 LTR

D 31, SITE IV, UPSIDC INDUSTRIAL AREA, KASNA, GREATER NOIDA 201 306, U.P.
, INDIA
MASTER FORMULA RECORD
PRODUCT: DOUBLE BLOOD BAG 350 ML CAPACITY CONTAINING 49 ML ANTICOAGULANT CPDA

SOLUTION IP
MFR NO. REV. NO. EFFECTIVE. DATE PAGE No.
BL-MFR-350-CA-D 02 02.11.2019 1 of 21
MASTER FORMULA APPROVAL

Preparation, review and approval of this Master Formula is the responsibility of the Biolife medical (P)
Ltd.
The signatures on this page indicate that the signatories have prepared and reviewed the contents of
the master formula.
NAME DEPARTMENT& DESIGNATION SIGNATURE DATE
PREPARED BY
AJIT KUMAR PRODUCTION SUPERVISOR 02-11-2019
REVIEWED BY
RAM KUMAR SHARMA MANAGER PRODUCTION 02-11-2019
APPROVED BY
MONU KUMAR
QUALITY MANAGER 02-11-2019
SHARMA
D 31, SITE IV, UPSIDC INDUSTRIAL AREA, KASNA, GREATER NOIDA 201 306, U.P., INDIA

SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 2 of 21
1.0 NAME OF THE PRODUCT
Double Blood Bag of 350 ml capacity containing 49 ml anticoagulant CPDA solution-IP
2.0 PRODUCT CODE
Code Description
B2CA356PUZVH Double Blood Bag-350 ml Containing 49 ml anticoagulant Citrate,
Phosphate Dextrose, Adenine Solution-IP
2.0 BRAND NAME
BLOOD BAG
3.0 GENERIC NAME
Anticoagulant Citrate, Phosphate Dextrose, Adenine Solution-IP (CPDA –IP)
4.0 CATEGORY
Large Volume Parenterals Dosage forms in PVC Bags. Each dosage unit contains 49 ml of
anticoagulant CPDA solution IP for collection, storage, preparation or preservation of 350 ml of human
blood or its components.
5.0 SHELF LIFE
2 years
6.0 PACK SIZE
06 units/Aluminum pouch
60 units/carton
7.0 BATCH SIZE OF BULK ANTICOAGULANT SOLUTION
150 Ltr.
9.0 TOTAL UNITS
2304 bags
10.0 COMPOSITION OF THE PRODUCT
Prepared By Reviewed By

SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 3 of 21
Each 100 ML contains:
Citric Acid (Anhydrous) IP 0.299 g

Sodium Citrate ( Dihydrate ) IP 2.630 g
Sodium Dihydrogen Phosphate (Dihydrate) IP 0.251 g
Dextrose (Monohydrate) IP 3.19 g
Adenine (Anhydrous) IP 0.0275 g
Water For Injection IP q.s. 100 ml
11.0 NAME, QUANTITY, AND REFERENCE NUMBER OF STARTING & PACKAGING MATERIALS
11.1 Overages: Adenine (Anhydrous) IP shall be taken 3% in excess of required qty.
11.2 RAW MATERIALS REQUIRED FOR 150L BULK CPDA SOLUTION:
RM SPECIFICATION QTY. REQD. / TOTAL QUANTITY

DESCRIPTION
REFERENCE 100ML REQUIRED
Citric Acid (Anhydrous) IP or 0.299 g 448.5 gm

BL-RM-002
Citric Acid (Monohydrate) IP 0.327 g Kg
BL-RM-003 Sodium Citrate (Dihydrate ) IP 2.63 g 3.945 Kg
Monobasic Sodium Phosphate gm

BL-RM-004 0.251 g 376.5
(Dihydrate) IP
Dextrose (Monohydrate) IP or 3.19 g Kg

BL-RM-001
Dextrose (Anhydrous) IP 2.9 g 4.350 Kg
BL-RM-005 Adenine IP 0.0275 g 41.25 gm
BL-QC-006 Water For Injection IP q.s. 100 ML 150 Ltr.
11.3 EMPTY CONTAINER AND ASSEMBLIES

SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 4 of 21
QTY.
REFERENCE DESCRIPTION REQUIRED/UNIT
QTY. REQUIRED
BL-QC-039 Empty Bag (Main Bag) 1 2304
BL-QC-039 Transfer Bag (300ML) 1 2304
BL-PC-005 Needle Assembly 1 2304
BL-PC-004 Safety Cover 1 2304
BL-PC-008 PVC Tube 1.7mtr and 5% extra 1 4112
11.4 PACKAGING MATERIALS
Qty. Ovg.
REFERENCE Description Qty. Required
Required/unit Up to
1% 2327
BL-PM-001 Label Inner 1 Unit Unit
1% 2350
BL-PM-003 Laminated Pouch 1 Unit Unit
1% 392
BL-PM-004 Label for Secondary pack 1/6 Unit Unit
10% 43
BL-PM-004 Label For C Box 1/60 Unit Unit
NIL 392
BL-PM-002 Aluminum Pouch 1/6 Unit Unit
NIL 39
BL-PM-005 Shipping Carton for Single blood bag 1/60 Unit Unit
Note: Approved copies of label & packaging material are attached.
12.0 PROCESSING LOCATION WITH PRINCIPAL EQUIPMENT USED

SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 5 of 21
Activity Location Equipment
Empty container Making Bag Welding Kiefel Machine

area
Label Printing Printing Area inkjet printer
Dispensing of chemical Dispensing Weighing Balance
Raw Materials Area Dispensing booth
Mixing Tank, circulation pump, filter, filter housing
Mixing Mixing Room
etc.
Filling Filling Room Filling Machine, LAF, holding tank etc
Primary
Over pouch Sealing Packaging Pouch Sealing Machine
room
Sterilization
Sterilization Superheated water spray Sterilizers
Area
Sterilization
Drying Dryers
Area
BB Packing Inspection table with illuminated background
Packing
Area Aluminum pouch sealing m/c
13.0 FINAL YIELD WITH RELEVANT INTERMEDIATES YIELDS
Expected Yield%
Stage
Min Max
Solution filling process Yield 95 % 100 %
Expected Final Product Yield 95 % 100 %
Note: Actual final yield is considered in normal processing conditions. It may vary due to
breakdown in machines.
14.0 CRITICAL PROCESS COMPLETION AND TIME LIMITS
Process Maximum Time

Mixing 25 Minutes
Filling of Solution 7 Hours
Over pouching (CPP) 7 Hours
Time elapsed between solution mixing to sterilization 30 Hours

SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 6 of 21
Visual inspection and carton packing after drying 10 Days
15.0 ENVIRONMENTAL CONDITIONS
Parameter Limit
Temperature 0C 21-25 0C
Relative Humidity (%) 50-55%
mm Pascal w.r.t. ambient as per respective area
Differential Pressure
chart
16.0 PROCEDURES
16.1 Issuance of BMR
16.1.1 Production associate shall generate requisition slip to Store department for issuance of
Material and requisition slip to QA for issuance of blank BMR one day in advance to start of
production.
16.1.2 QA associate shall issue batch manufacturing record as per SOP that shall be checked by
Production Associate.
16.1.3 Production associate shall get approval of PWO by production manager and QA manager.
Note:
One approval signature on PWO is mandatory, in absence of both; any approved manufacturing
chemist can approve PWO.
16.2 Issuance of Starting Materials
16.2.1 Store personnel shall issue starting materials as per approved PWO
16.2.2 Dispensing of Chemical Raw Materials [Reference SOP No. BL-PR-006]
16.2.2.1 Weigh the raw materials as per quantity given in approved PWO using the .
calibrated weighing balance of appropriate least count.
16.2.2.2 Special Precautions:
a) Ensure the cleanliness of area.

SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 7 of 21
b) Ensure that the UV lights & LAF are on for 15 minutes before starting the
dispensing.
c) Ensure that LAF starts before 15 minutes (at least) of starting the weighing.
d) Check that only released raw materials indicated on the PWO are brought
inside the Dispensing area.
e) Ensure the cleanliness of primary containers.
f) Visually ensure the cleanliness of the weighing tools.
16.2.2.3 Responsibility
Store Personnel, Manufacturing Chemist & QA Associate
16.3 Issuance of Empty Container & Assemblies
16.3.1 Enter the required quantity of empty container, needles assembled, , tube etc. in the
requisition slip & get the material issued from the In-process material store of concerned
department.
16.3.2 Responsibility
Store Personnel, Production Associate
16.4 Issuance of packaging and labeling Material
Store personnel shall issue Packaging and labeling materials as per approved PWO.
Get the material from store against approved production work order & also record the same in BMR.
Store Personnel, Production Associate
16.5 Empty Container Making
16.5.1 Double blood bags are manufactured on Kiefel machine as per SOP
16.5.3 Separate the bag by tearing and remove extra sheet.
16.5.4 After separation of bags, transfer the bags for visual inspection.

SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 8 of 21
16.5.5 Safety precautions
1. Only qualified personnel are allowed to work on the machine.
2. Always use the correct tools and equipment.
3. Always wear suitable protective clothing.
4. Obey the installation and maintenance procedures in the manual.
5. Make sure all electrical and pneumatic supplies are shut down and cannot be
accidentally turned on.
6 Release the pressure from pressurized system before working on the machine.
7 Always replace unserviceable parts with approved parts.
8
Dont modify m/c in any way except when approved in written by manufacturer.
Manufacturer.
Production Associate
16.5.7 Visual Inspection of Empty sealed Container
Inspect 100 % bags for the following defects but not limited to them:
Sheet Particle
Port spot
Port sealing Open
Tearing
Tube joint
Wrinkle in Sheet
Break Valve Tube Spot
Loose Particle
Hair in Bag
Without port
Sealing problem
Sheet fold
Extra sheet
Bursting testing
16.6 Label Printing
16.6.1 Receive labels from the store

SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 9 of 21
16.6.2 Before starting clean the machine with 70% IPA
16.6.3 Ensure that environmental condition like temperature and pressure differential are with in
limits.
16.6.4 Before start working in printing area ensures that there is no any material of previous batch
like label etc.
16.6.5 Feed the printing information in the printer as per PWO.
16.6.6 Check the printing information and get approved by production associate as well as Quality
Personnel.
16.6.7 Print the labels as per requirement of batch.
16.6.8 After completion of printing dispose the rejected or extra labels.
16.6.9 Record all information regarding label printing on BMR.
16.6.10 In process Inspection
a. During printing, inspect and check the printing quality and matter of labels.
b Perform 100% visual inspection for print defects.
16.6.11 Special Precautions:
a. Ensure cleaning and sanitization of printing equipments.
b. Check printing line for line clearance no material of previous batch.
c. Change the batch board to show the correct batch no., product code and exp.date.
d. Verify that printing is correct.
16.6.8 Assembly of donor tube, needle safety shield & main bag as per SOP No. BL-PR-021
16.6.8.1 Perform the line clearance as per SOP BL-QS-026

SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 10 of 21
16.6.8.2 Fix donor tube in the transfer port (TC 01) of the bag.
16.6.8.3 Insert open end of donor tube into the needle safety shield & pass through it.
16.6.8.3 Record length of donor tube in the BMR & get the assembly approved by QA
before starting production.
16.6.8.4 Reconcile the assembled bags in the BMR.
16.7 PREPARATION OF SOLUTION. (REFERENCE SOP BL-PR-007 )
16.7.1 Check system release as per sop BL-QS-007.
16.7.2 Perform the line clearance as per SOP BL-QS-026 and maintain the record the BMR before
starting of the activity.
16.7.3 Ensure that mixing room, mixing tank and transfer pump has been cleaned & sanitized as per
SOP BL-PR-015, cycle shall be followed whenever there is change in the concentration of
product.
16.7.4 Ensure that all raw materials have been dispensed as per approved PWO by rechecking the
raw material weights.
16.7.5 At start of mixing personnel should disinfect their hands with 70% IPA solution.
16.7.6 Before start of mixing ensure that the identification labels on dispensed raw material has been
put by ware house (Store) and the same information has been mentioned in the relevant
PWO.
16.7.7 Collect already approved water for injection in the mixing tank up to agitation level. Check
temperature of Water for injection, it shall not be less than 700 C.
16.7.8 Switch ‘ON’ the stirrer of mixing tank & add chemical ingredient one by one in the following
order.
Chemical Mixing Sequence as per SOP
Citric Acid Sodium Citrate Sodium Dihydrogen Phosphate Adenine

Dextrose

SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 11 of 21
NOTE: First take the weighed adenine in borosilicate flask and dissolve it in 3-4 liter
of WFI manually. Without this pretreatment adenine shall not be added to
mixing tank.
16.7.9 Mix up each chemical for 5 minutes and Make up the batch to final volume by adding water
for injection up to mark. Continue the mixing of solution for another 25 minutes.
16.7.10 After completion of mixing draw the bulk sample and send to QC for initial chemical analysis
along with “Solution Identification and Status Cum Intimation Slip”.
16.7.11 After getting the QC test report, release bulk solution for filling.
16.7.12 Special Precautions
a. Ensure the cleanliness of mixing room, mixing tank.

b. Ensure that mixing tank has been cleaned as per SOP "Cleaning and sanitization of
production area and fill the cleaning status card.
c. Ensure that WFI is approved for batch preparation by QC department.
Manufacturing Chemist
16.8 FILLING OF BAGS (REFERENCE SOP BL-PR-009)
16.8.1 Personnel working in filling room must follow GMP and gowning procedure as per sop B-PR-
018.
16.8.2 Perform the line clearance as per sop BL-QS-026.
16.8.3 Ensure the cleaning of area and LAF has been done.
16.8.4 Before start of filling ensure that solution has been released from QC for filling.
16.8.5 At the start of filling personnel should disinfect their hands with 70% IPA solution.
16.8.6 Filter the solution through 2 µ prefilter 0.20 µ final filter.
16.8.7 Flush about 1 ltr solution from each nozzle & record in BMR.
16.8.8 Adjust vol. of CPDA solution as per following table:

SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 12 of 21
Product Nominal volume required for

Filling Volume (extracted)
capacity Anticoagulant CPDA Solution
350 ml 49 ml 52-54 ml
16.8.9 Before start of filling of solution, check the printing matter on labels according to approved
production work order.
16.8.10 Hold and fix the filling tube first on the vacuum nozzle for vacuum & then on filling nozzle for
filling of solution.
16.8.11 Hold and fix the filling tube on filling nozzle for filling.
16.8.12 Let the solution be filled in the solution bag for the complete filling.
16.8.13 After filling remove bag from nozzle, hold the bag and fix the needle into open end.
16.8.14 Transfer the filled bag for the leakage testing and pouching.
16.8.15 In process Inspections
a. Check the Volume of filled bags from each nozzle at interval of approx 30 minutes and
record in BMR. The Volume of filled solution must be within limit
a. Ensure the cleaning and sanitization of filling room.
b. Ensure the cleaning and sanitization of filling nozzles and filling line before start.
c. Check the filling room for line clearance and fill the record in BMR.
d Ensure solution tank is released by QC.
e. Ensure, solution lines from the tank to filling machine are not leaking.
f At start of the work or whenever the operators touch non-product contact surface, the
filling operators must disinfect their hands with 70% filtered IPA solution.
16.10 OVER POUCHING & SEALING (REFERENCE SOP BL-PR-011)


SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 13 of 21
16.10.1 Ensure the line clearance in the before start the activity and record in the BMR.
16.10.2 Coil the tube & place the bag in to the CPP pouch
16.10.3 The operator shall hold the blood bag unit from the open end of over pouch
and place the bag in vacuum sealing m/c and seal the bag as per defined procedure
16.10.4 Sealing machine parameters for Blood Bag are as follows:

a) Webomatic Sealing Machine : BL/PR/12
Parameter CPP
Seal time 1.3 to 1.9 sec
Vacuum 4 to 5 sec.
16.10.5 Clean any pouched bag, which accidentally dropped on the floor with 70%, filtered IPA
16.10.8 Inspect the quality of the sealing.
16.10.9 Re-seal the unit using new pouch if sealing is tilted or loose.
16.10.10 In Process Inspections:
Check all the bags at least for the following but not limited to them:
1. Bag Leakage
2. Label Printing
3. Sealing Problem
4. Port Spot
5. Tube Spot
6. Solution Particle
7. Extra Bag(In complete coiling)
8. Tearing Problem
9. Sheet Spot
10. Label spot
11. Label shifting Problem
12. Port open
13. label sealing
14. Without print on label
15. Loose Particle
16. BAV spot

SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 14 of 21
17. Tube Kink

18. Needle guard position in coiled bag
16.10.11 Record the observations in BMR
16.10.13 After visual inspection send the OK pouch packed bags to sterilization.
a. Ensure cleaning and sanitization of overpouch sealing area

b. At start of over pouching or whenever the personnel touch non-product, contact
surface, should disinfect their hands with 70% IPA.
16.11 Terminal Sterilization of Filled Bags (118 for 32 minutes)
(A) Truck Loading
16.11.1 Check the cleanliness of sterilization area
16.11.2 Perform the line clearance as per sop BL-QS-026.
16.11.3 Check the availability of utilities.
16.11.4 The filled bags received from over pouch section are loaded into sterilization truck as per
following load pattern
Total Total Units/ Total used Total

Type of Bag Units/tray Trolley
Tray Trolley Units/cycle
Double Blood 96 24 768 96 2304
bag
16.11.5 Arrange filled bags in such manner that the print side of filled bag should face toward tray
surface.
16.11.6 Fill all data regarding truck loading in BMR.
a. Check the truck loading area for line clearance and cleaning status of area and
equipment.

SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 15 of 21
b. In process record of truck loading and sterilization should be filled in the relevant BMR.
(B) Sterilization Procedure (Reference SOP BL-PR-008)
16.11.9 Load the sterilization truck in sterilizer by opening loading door then close the door.
16.11.10 Select the cycle from control panel and start process as per SOP.
16.11.11 Cycle Parameters:
Parameters Value
Sterilization Holding Temperature 118 0C
Holding time 32 min
Holding pressure 1.2 bar
Cooling Temperature 600C
Cooling Pressure 1.4 bar
16.11.12 Document all data and attach the graph with BMR.
16.11.13 After completion of sterilization process, open the unloading door and take out for the
process of drying of the bags.
16.12 DRYING OF BLOOD BAGS
16.12.1 After completion of sterilization unload the truck from sterilizer.
16.12.2 Load the sterilizer truck in to the dryer.
16.12.3 Set the temperature of dryer at 70 degree.6 hrs. holding Dry time.
Parameters Value
Moisture removal Temperature 30 0C
Cycle Temperatue 70 0C

SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 16 of 21
Band 0.1 0C
Off set value 1.5 0C
Hold time 420 minutes
Sterilization count stop temp 60 0C
Sterilization Reset count temp 59 0C
Over shoot temp 78 0C
Blower time on 30 Sec.
Process end temp. 45 0C
16.12.4 Record the detail of starting time & temperature of dryer in the BMR.
16.12.7 After achieving ambient temperature condition within the dryer unload the bags in plastic bins
and transfer to visual inspection area.
a. Ensure that all blood bag of previous batch are removed from dryer.
b. Ensure that the heaters and fan of the dryer are working properly.
16.13 Aluminum Pouch labeling and packing
16.13.1 Receive aluminum pouch from store as per Production work order
16.13.2 Before starting clean the machine with 70% IPA
16.13.4 Before start working in printing area ensures that there is no any material of previous batch.
16.13.5 Apply the label as per PWO.
16.13.6 Check the printing information and get approved by production associate as well as Quality
Personnel.
16.13.7 Print the label as per requirement of batch.
16.13.8 Duly signed printed specimen label by production and QA person, shall be attached along
with the BMR.

SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 17 of 21
16.13.9 After completion of printing dispose the rejected material. Put the OK pouches in a poly bag, it
should be tied with PVC tube & put identification slip on it.
16.13.11 In process Inspection
a. During printing inspect and check the printing quality and matter of aluminum pouch
label.
16.14 Final Inspection & Aluminum Pouch Packing Of Blood Bags
16.14.1 After completion of drying process of blood bags, unload the bags in plastic bins.
16.14.2 Before shifting of the dried bags in the packing area ensure the line clearance is performed
and records are maintained in the BMR.
16.14.3 Transfer the bags from dryer to the final visual inspection area through Lift.
16.14.4 At the time of packing ensure that all bags from previous batch have been removed from
packing line and packing line has been cleaned.
16.14.5 Visually inspect the 100% blood bags at least for the following defects but not limited to.
a. Variable text of blood bags as per PWO.

b. Product detail
c. Types of bag
e Batch no.
f Mfg. date
g Exp. date
h Tube kink
I Black particle on bag or pouch
j Moisture
k Leakage of bag
lm Label spot or pouching
n Any mix up
o Needle safety shield spot, crack & locked
p solution particle
q Pouch damage
r Sheet fold
t Label shifting
u Miss printing on tube

SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 18 of 21
v Damaged/broken needle
16.14.6 During inspection, checkers shall check the defects of white particle on a black background
and black particle on a white background
16.14.7 The visual checkers shall be given break after every two hours. Only qualified visual
inspection checkers shall be allowed to carryout the visual inspection.
16.14.8 After visual inspection clean outer & inner surfaces of CPP pouches with IPA and pack 6 unit
packs in pre labeled aluminum pouch.
16.14.10Seal the aluminum pouches on Webomatic vacuum sealing machine. Parameter of sealing
machine shall be as given in the table-
Parameter Range
Seal time 2 to 3 sec
Vacuum 2 to 3 sec.
16.15 Carton Packing
16.15.1 Before start of packing, ensure that all material of previous batch has been removed from
packing line and the line has been cleaned.
16.15.2 Verify variable text of aluminum pouch label and carton label with PWO.
16.15.3Pack the aluminum pouch in carton as per following table:
No. of units pack/ No. of Pouch pack/

Types of bags
Carton Carton
All types of Double blood bags 60 06
16.15.5 Print the required numbers of cartons labels received from store as per PWO of the batch
under packing.
16.15.6 During printing of cartons labels ,check printing quality, printing contents and printing
placements and record on BMR. Reject carton with illegible print and contents will be
repacked using a new carton
16.15.7 Form the carton and put the specified no. of aluminum pouch & clips as mentioned below:

SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 19 of 21
No. of units pack/ No. of Pouch pack/

Types of bags
Carton Carton
Double Blood Bag 60 06
16.15.9 Fold the flaps and seal the carton with tape.
CARTON ACCOUNTABILITY
16.15.11 Clear the line of any printed materials from the previous batch before starting activity.
16.15.12 Loose package should be accurately counted.
16.15.14 Reconcile the quantity of packaging materials on BMR
PALLETIZING OF CARTONS
16.15.15 Arrange maximum layer of shippers on each pallet as per SOP BL-PR-011.
16.15.16 Inspect every pallet for the following
a. Correct cartons are used
b. Product Name, Code, Batch No. Mfg. Date, Expiry Date, Retail Price and other details
printed are correct
a. Check the line clearance of packing line and Fill the record.
b. Check no. of units in aluminum pouch carefully before sealing of the pouch.
Production Associate.
16.16 Terminal Inspection
16.16.1 After the completion of the packing, Packing In charge shall intimate to QA for the terminal
inspection.
16.16.2 After receiving the intimation QA Associate shall perform the terminal inspection as per SOP
BL-QS-007.

SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 20 of 21
16.16.3 After the successful completion of the terminal inspection the batch may be transferred for the
next process.
16.16.4 If the batch does not pass the terminal inspection by QA then it will be treated as non
conforming material & handled as per SOP (Handling of nonconforming products.
16.17 Batch Release [As Per SOP BL-QS-006]
16.17.1 After packing production associate shall fill finished goods quarantine slip and handover the
product to logistic personnel.
16.17.2 Logistics personnel shall shift the finished product to finished product quarantine area.
16.17.3 After filling of BMR production manager or his designee shall review the BMR.
16.17.4 If the result of the review is satisfactory, the head of production or approved manufacturing
chemist shall sign on each page of Batch manufacturing record and submit the same to the
QC department.
16.17.5 After completion of finished product analysis as per finished product specifications, QC
associate shall send the finished product certificates to Quality Control Manager for review.
16.17.6 If the result of the review is satisfactory, the Quality Control Manager or his designee shall
approve the "Certificate Of Analysis" (COA) & attach with the BMR.
16.17.7 The batch manufacturing record and the analytical reports duly authorized by manufacturing
& analytical chemists shall be forwarded to the QA department.
16.17.8 The QA associate shall fill "Final Product Verification & Release Record" & attach with BMR.
16.17.9 The review of the finished product batch record shall take following consideration but not
limited to:
a. Performance of manufacturing operations according to approved sop

b. Completeness, accuracy of data and all necessary signatures.
c. Performance of process controls and result.
d. Results of in process inspections performed by production and QA Associate.
e. Result of the investigation of OOL situation if applicable.
f. Review of deviation, if applicable.
g. All tests have been performed and that the product conforms its specifications.
h. Corrections are adequately made.
I. All raw materials/Plastic materials are released by Quality control.
j. Batch numbers referred are correct.
l. Verify number of finished product bags mentioned in production batch record and received
by warehouse department.

SOLUTION IP
BL-MFR-350-CA-D 02 02.11.2019 21 of 21
m. System release
16.17.10 Once the review is complete, If this review show that the lot complies with its specifications
and has been manufactured according to the established parameters and procedures, the
documentation associate shall arrive to the conclusion that the lot can be released.
16.17.11 The entire finished product batch record shall be delivered to the quality assurance manager
or his designee for reviewing and final approval of the batch
16.17.12 After release of batch from QA, the BMR along with copies of "Batch Release Certificates"
shall be handed over to the manufacturing chemist.
16.17.13 The manufacturing chemist shall submit the copy of "Batch Release Certificate" along with
the material to the in-charge of warehouse.
16.17.14 Warehouse in-charge shall shift the complete material of batch from quarantine area to the
approved finished goods storage area.
17.0 Storage
Not exceeding 30˚ C.
18.0 Handling
Handling of the finished goods shall be done in a manner to avoid damage to the bags
19.0 ABBREVATIONS
BMR : Batch manufacturing record

QA : Quality Assurance
QC : Quality Control
OOL : Out Of Limit
PWO : Production work order
UV : Ultra Violet
LAF : Laminar Air Flow
PVC : Poly Vinyl Chloride
IPA : Iso Propyl Alcohol
PLC : Programmable Logic Control
COA : Certificate Of Analysis
CPP : Cast Poly Propylene

MFR Double 350 ML CPDA - 150 LTR

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

MFR Double 350 ML CPDA - 150 LTR

Uploaded by

Copyright:

Available Formats

D 31, SITE IV, UPSIDC INDUSTRIAL AREA, KASNA, GREATER NOIDA 201 306, U.P.

MASTER FORMULA RECORD

PRODUCT: DOUBLE BLOOD BAG 350 ML CAPACITY CONTAINING 49 ML ANTICOAGULANT CPDA

MASTER FORMULA APPROVAL

NAME DEPARTMENT& DESIGNATION SIGNATURE DATE

AJIT KUMAR PRODUCTION SUPERVISOR 02-11-2019

RAM KUMAR SHARMA MANAGER PRODUCTION 02-11-2019

MASTER FORMULA RECORD

PRODUCT: DOUBLE BLOOD BAG 350 ML CAPACITY CONTAINING 49 ML ANTICOAGULANT CPDA

1.0 NAME OF THE PRODUCT

Double Blood Bag of 350 ml capacity containing 49 ml anticoagulant CPDA solution-IP

2.0 PRODUCT CODE

2.0 BRAND NAME

3.0 GENERIC NAME

Anticoagulant Citrate, Phosphate Dextrose, Adenine Solution-IP (CPDA –IP)

5.0 SHELF LIFE

6.0 PACK SIZE

7.0 BATCH SIZE OF BULK ANTICOAGULANT SOLUTION

9.0 TOTAL UNITS

10.0 COMPOSITION OF THE PRODUCT

MASTER FORMULA RECORD

PRODUCT: DOUBLE BLOOD BAG 350 ML CAPACITY CONTAINING 49 ML ANTICOAGULANT CPDA

Each 100 ML contains:

Citric Acid (Anhydrous) IP 0.299 g

11.1 Overages: Adenine (Anhydrous) IP shall be taken 3% in excess of required qty.

11.2 RAW MATERIALS REQUIRED FOR 150L BULK CPDA SOLUTION:

RM SPECIFICATION QTY. REQD. / TOTAL QUANTITY

Citric Acid (Anhydrous) IP or 0.299 g 448.5 gm

BL-RM-003 Sodium Citrate (Dihydrate ) IP 2.63 g 3.945 Kg

Monobasic Sodium Phosphate gm

Dextrose (Monohydrate) IP or 3.19 g Kg

BL-RM-005 Adenine IP 0.0275 g 41.25 gm

BL-QC-006 Water For Injection IP q.s. 100 ML 150 Ltr.

11.3 EMPTY CONTAINER AND ASSEMBLIES

MASTER FORMULA RECORD

PRODUCT: DOUBLE BLOOD BAG 350 ML CAPACITY CONTAINING 49 ML ANTICOAGULANT CPDA

BL-QC-039 Empty Bag (Main Bag) 1 2304

BL-QC-039 Transfer Bag (300ML) 1 2304

BL-PC-005 Needle Assembly 1 2304

BL-PC-004 Safety Cover 1 2304

BL-PC-008 PVC Tube 1.7mtr and 5% extra 1 4112

11.4 PACKAGING MATERIALS

Note: Approved copies of label & packaging material are attached.

12.0 PROCESSING LOCATION WITH PRINCIPAL EQUIPMENT USED

MASTER FORMULA RECORD

PRODUCT: DOUBLE BLOOD BAG 350 ML CAPACITY CONTAINING 49 ML ANTICOAGULANT CPDA

Activity Location Equipment

Empty container Making Bag Welding Kiefel Machine

Filling Filling Room Filling Machine, LAF, holding tank etc

13.0 FINAL YIELD WITH RELEVANT INTERMEDIATES YIELDS

14.0 CRITICAL PROCESS COMPLETION AND TIME LIMITS

Process Maximum Time

MASTER FORMULA RECORD

PRODUCT: DOUBLE BLOOD BAG 350 ML CAPACITY CONTAINING 49 ML ANTICOAGULANT CPDA

Visual inspection and carton packing after drying 10 Days

15.0 ENVIRONMENTAL CONDITIONS

16.1 Issuance of BMR

16.2 Issuance of Starting Materials

16.2.2 Dispensing of Chemical Raw Materials [Reference SOP No. BL-PR-006]

16.2.2.2 Special Precautions:

a) Ensure the cleanliness of area.

MASTER FORMULA RECORD

PRODUCT: DOUBLE BLOOD BAG 350 ML CAPACITY CONTAINING 49 ML ANTICOAGULANT CPDA