PHARMA DEVILS

PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Procedure for Cleaning and Operation of Blister packing machine (BQS) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

1.0 OBJECTIVE:
To lay down a procedure for Cleaning and Operation of Blister packing machine (BQS).

2.0 SCOPE:
This procedure is applicable for Cleaning and Operation of Blister packing machine (BQS).

3.0 RESPONSIBILITY:
Technical Associate : Cleaning and Operation
Production : Officer / Executive / Assistant Manager
Head Production: To ensure execution & compliance.

4.0 PROCEDURE:
4.1 TYPE A CLEANING
Change over from one batch to next batch of the same product, same potency and of
similar product with ascending potency provided the color is same.
4.1.1 Ensure that all the materials of previous batch are removed from the blister packing cubicle.
4.1.2 Replace the ‘UNDER PROCESS‘ status label by ‘TO BE CLEANED’ status label then
‘UNDER CLEANING’ while starting the cleaning procedure.
4.1.3 Clean the machine, hopper and bowl with dry lint free cloth.
4.1.4 Clean the feeding channel, tablet supporting drum, guide track, sealing unit and forming unit
with dry lint free Cloth.
4.1.5 Clean the sealing unit with Copper wire brush.
4.1.6 Clean the guide track and all supporting parts with dry lint free Cloth.
4.1.7 Clean the punching tools with dry lint free Cloth.
4.1.8 Clean the stereo roller (after stereo removal), supporting shafts with thinner followed by
cleaning with dry lint free cloth.
4.1.9 Clean the punching tools with dry lint free cloth. clean the trim and pack reject delivery chute,
conveyor belt with dry lint free cloth.
4.1.10 Clean the control panel, machine body, base, acrylic guards and other non-contact parts with dry
lint free Cloth.
4.1.11 Record the cleaning activity in equipment usage log as per SOP.
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Procedure for Cleaning and Operation of Blister packing machine (BQS) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

4.1.12 Maintain the cleaning checklist as per Annexure - I.

4.2 TYPE B CLEANING

This is a cleaning procedure for Changeover of product with different actives / color /
descending potency or after maintenance of contact parts.
4.2.1 Replace the ‘UNDER PROCESS‘ status label by ‘TO BE CLEANED’ status label then
‘UNDER CLEANING’ while starting the cleaning procedure.
4.2.2 Dismantle the hopper, hopper lid, Linear and rotary vibrator, feeding channel assembly
(including Tablet supporting drum), vibrating plate and guide track.
4.2.3 Clean the dismantled parts hopper, hopper lid, vibrating plate, and feed channel with dry lint free
cloth and transfer to washing area in poly bag. Scrub the dismantled parts with a nylon scrubber
using purified water. Finally rinse all the cleaned parts with the sufficient amount of purified
water.
4.2.4 Dry the cleaned parts with a dry lint free cloth.
4.2.5 Wipe the dismantled parts with lint free cloth dipped in 70% v/v IPA solution.
4.2.6 Remove the perforation tool, indexing roller and punching tool from the machine and clean with
dry lint free cloth.
4.2.7 Clean the sealing unit with a cooper wire brush followed by dry lint free cloth.
4.2.8 Clean the forming, sealing and cooling plate with wet lint free cloth followed by dry lint free
cloth, cover with polybag and transfer to the packing change part room.
4.2.9 Clean the stereo roller, supporting shafts with thinner followed by dry lint free Cloth.
4.2.10 Clean the inner and outer surface of the machine, control panel and utility lines with wet lint free
cloth followed by dry lint free cloth.
4.2.11 Wipe the machine with 70% v/v IPA solution.
4.2.12 Reassemble the cleaned hopper, channel and hopper lid.
4.2.13 Transfer the guide track; feeding channel, sealing and forming plate to the packing change part
room.
4.2.14 Replace the ‘UNDER CLEANING’ status label by ‘‘CLEANED’’ status label with date and
sign of the production officer as per SOP.
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Procedure for Cleaning and Operation of Blister packing machine (BQS) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

4.2.15 Record the Cleaning Activity ‘time’ in equipment usage log sheet and clean the area as per SOP.
4.2.16 Maintain the cleaning checklist as per Annexure II.
4.3 MMI Setting:
4.3.1 Switch ‘ON’ the power supply of machine. The below Screen will display-

4.3.2 Press Log In Button. Following screen will be displayed

4.3.3 The system will show forming (lower and top) and sealing heater temperature (Set & Actual).
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Procedure for Cleaning and Operation of Blister packing machine (BQS) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

4.3.4 The display showing speed of the machine in cycles / min and Position of machine (0-999 in one
cycle).
4.3.5 Enter the values for temperature and other by pressing on the respected icon on the screen, a
keypad will appear, enter the value and press ENTER key to save.
4.3.6 After pressing of Function key the below screen will be displayed-

4.3.7 All inputs which are ‘ON’ are indicated with Green signal, Red signal indicates the input is
‘OFF’.
4.3.8 On pressing the ‘Special function key’ in the Main screen, the below will be displayed. Here
user can monitor various data / PLC inputs and outputs for operation and information purpose.
4.3.9 In special function, various key / parameters can be selected such as Alu-Alu, unseal, chiller
supply, joint rejection, print rejection, pinhole rejection. Etc. as per requirement.
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Procedure for Cleaning and Operation of Blister packing machine (BQS) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

4.3.10 ‘PRC key’ in the Main screen is used for basic correction ,PRC correction, Advance ( current
draw of length of format part in mm)
4.3.11 Power fail correction : This key in the Main screen is applicable for power fail recovery , press
power fail correction and another screen will open which will show ”Start without home key”
then press this key for recovery of servo axes or to perform correction after power fail as per
below screen -
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Procedure for Cleaning and Operation of Blister packing machine (BQS) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

4.3.12 Machine setting :It contains the key for Basic cams, Cyclic cams, User cam,
Universal cams, Timers, Recipe, and Manual mode which shall be used as per requirement.
4.3.13 Timers: This key in the Main screen is applicable for setting of time for different
Parameters such as machine off time for unseal, un print, un emboss, conveyor off delay timer,
lidding and base foil joint timer etc.
4.3.14 Recipe: It contains different parameter as per below screen:-
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Procedure for Cleaning and Operation of Blister packing machine (BQS) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Procedure for Cleaning and Operation of Blister packing machine (BQS) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

4.3.15 Manual Mode: Manual mode is recommended during change over and trouble shooting. It
contains different parameter as per below screen:-

4.4 LOAD RECIPE: User can Save/Load up to 20 Recipe using above screen. User can save all
change part parameter in one recipe.
4.4.1 Once it is set various change part parameters like Advance (draw of length) and number of
punching cycles. User can press RECIPE key to calculate all other parameters.
4.4.2 RECIPE helps to give nearby values for each parameter and need to correct other 2 parameters
like no of blisters on feeding drum and printing drum as per actual. In few cases it may not
match.
4.4.3 Similarly for other offsets user need to correct as per loop set between pulling and punching
station.
4.4.4 Once all parameters are set and functionally tested we can store the data for change part under
recipe Press ENTER key to save. Recipe will store data.
4.4.5 If user wants to recall the recipe by putting the number and giving LOAD command all
parameters related to that recipe will be loaded.
4.5 OPERATION:
4.5.1 After line clearance from QA, put the “UNDER PROCESS” label on the machine as per SOP
before starting of the operation.
4.5.2 Switch “ON” the mains from electrical panel.
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Procedure for Cleaning and Operation of Blister packing machine (BQS) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

4.5.3 Ensure the presence of sufficient water in the water cooler tank.
4.5.4 Open the valves of the chilled water and compressed air supply of machine.
4.5.5 Transfer all the primary packing material in the blister cubicle
4.5.6 Transfer all the approved containers to the primary packing cubicle.
4.5.7 Switch on the heater and adjust thermostat to provide the heating condition predetermined for
the particular product as mentioned in BPR.
4.5.8 Record the temperature of forming and sealing units in BPR.
4.5.9 Fix printed Aluminium Foil and PVC/PVDC/ALU foil rolls on the machine as per BPR.
4.5.10 Apply ink on the inking roller and BCP, add appropriate amount of blister aid for good printing.
4.5.11 Affix the approved stereos to the stereo drum of the BCP unit as per the instructions given in the
BPR.
4.5.12 Check the sealing performance, overprinting and cutting of blister. Adjust if required.
4.5.13 Affix the specimen of overprinted matter on foil approved by production Officer & QA officer
to BPR.
4.5.14 Cross checks the weight of individual container from the BMR.
4.5.15 charge the tablets into the hopper with a SS basket serially container wise and Perform the leak
test as per SOP.
4.5.16 Operate the machine as per BPR.
4.5.17 Enter the start time and end time of the operation in equipment usage log book as per SOP.
4.5.18 Affix ‘TO BE CLEANED’ label on the machine after completion of activity.
4.6 Precaution:
4.6.1 Wear PPE during machine cleaning and operation.
4.6.2 Any tablet that would have come in contact with the sealing plate shall be removed and
discarded.
4.6.3 When the machine is stopped during tea and lunch breaks, it must be ensured that no tablet is
retained in feed chute.
4.6.4 After the machine is restarted, a few empty blisters shall run initially to ensure the overprinting
details are clear and empty blister shall be removed for the line.
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Procedure for Cleaning and Operation of Blister packing machine (BQS) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

4.6.5 At the end of working shift, the product left in hopper or vibratory bowl and channel shall be
removed, any blister lying on the packing line should also be removed.

5.0 ANNEXURE (S):

Annexure I : Type ‘A’ Cleaning checklist for blister pack machine (BQS).
Annexure II : Type ‘B’ Cleaning checklist for blister pack machine (BQS).

6.0 REFERENCE (S):

SOP: Procedure for are line Clearance.
SOP: Status Labeling in Production dept.
SOP: Operation and cleaning and operation of leak test apparatus
SOP: Preparation, approval, distribution control, revision and destruction of Standard Operating
Procedure (SOP).

7.0 ABBREVIATION (S) /DEFINITION (S):

PLC : Programmable logical control.
MMI : Man machine interference.
NFD : Non Filled Detector.
BQS : Blistering Quickly through Servo.
QA : Quality Assurance
BPR : Batch Packing Record
PPE : Personal Protective Equipment.

REVISION CARD

S.No. REVISION REVISION DETAILS OF REVISION REASON (S) REFERENCE

No. DATE FOR CHANGE
REVISION CONTROL No.
1 00 ---- ---- New SOP ---