1.0 Purpose
1.1 To ensure a standard procedure for smooth operation, proper cleaning and appropriate use of Blister packing machine.
2.0 Scope
2.1 This procedure is applicable for Blister Packing machine of production area at “NAME” Pharmaceuticals
Ltd.
3.0 Responsibility
3.1. Only concern operator is responsible for normal operation. He/ She inform the supervisor about any deviation from normal operation. He also maintains logbook.
3.2. Sr. Officer- Production/Officer- Production is responsible for monitoring day to day activity.
3.3 Production and Quality Assurance Officer shall ensure that the procedure is implemented properly.
4.0 Abbreviations and Definitions
4.1
BMR :
Batch Manufacturing Record
5.0 Materials and Equipment
5.1 Tap water
5.2 Hand brush / Plastic Brush
5.3 Clean lint free cloth
5.4 Isopropyl Alcohol.
6.0 Precaution / Health and Safety Considerations
6.1 Regulation and Technical standards of energy
supply are to be surely observed.
6.2 The Operator should always be cautious of
the position and operating condition of the machine; temperature, degree of
humidity, vibration, dust and cleanliness of the room to be occupied.
6.3 The Operator must check all safety
mechanism to ensure that they are fully functional.
6.4 The Contact with heated element should be
avoided.
6.5 During changeover of the machine handle
the heavy change parts very carefully.
6.6 Don’t touch the moving parts of the
machine during operation.
6.7 Keep
the upper heating and sealing plate in upward position when the machine is
stopped.
7.0 Procedure
7.1 Before starting operation, the operators and
the personnel with this operation must ensure that the
Room is properly cleaned and all materials of previous product are removed.
7.2 Make sure all the necessary parts and equipment
of the Buchon Blister Packing machine in the
room with proper cleaning.
7.3 Set the machineries parts for a
particular product and prepare for operation in accordance with the
following procedures
7.4 Operation
7.4.1 Check
all the greasing point of the machine.
7.4.2 Supply power and compressed air to the
system. Maintain air pressure at min. 6 kg/cm2
7.4.3 Turn “ON” the main power switch.
7.4.4 Open
the main air supply valve.
7.4.5 Supply bottom materials (PVC etc.) into the
PVC uncoiler.
7.4.6 Insert cover foil (Aluminum etc.) into cover foil uncoiler.
7.4.7 Turn on each switch – 1) Heater switch of
pre-heating, sealing, slitting.
2) Chiller.
3) Draw-Off
7.4.8 Wait till temperature of each heater
reaches to the set value;
1) Upper and Lower
pre-heating (Std.) : 110-180º C
2) Sealing (Std.) :
150-200º C
3) Slitting (Std.) : 50-100º C
7.4.9 Set the AUTO MODE/MANUAL MODE
7.4.10 Set the position of followings
1) Sealing station
2) Slitting station
3) Forming station
4) Cooling station
5) Embossing station
7.4.11 After setting all the necessary parts and
programs, check all screw and nuts either they are
Properly
tighten or not. If not tighten all.
7.4.12 Now start to trial the machine whether it is
running smoothly or not, if it is ok then run the machine
for checking the blistered strip and
perform leak test.
7.4.13 After ensuring every parameter of the machine
is ok, then check the machine and forming blister
Strip by Production Officer and QA
Officer and then start the operation.
7.4.14 During operation perform leak test at one
hour interval.
7.5 Cleaning
7.5.1 After operation, put off power supply, air
supply and other parameters that are necessary to stop.
7.5.2 Remove the removable parts from the main
body of the machine and keep aside for proper cleaning.
7.5.3 Remove and isolate the unused primary
packing materials and send the returned quantity to packing store.
7.5.4 Remove dust/powder adhering with the removable
parts and the main body of the machine with the clean hand brush, then clean the surface with dampened lint
free cloth and again clean with dry clean
cloth.
7.5.5 Any power or dust which cannot be removed by means of brush to be clean with solvents like isopropyl alcohol which can be done by dipping clean cotton cloth in the solvent and then the cloth is used to clean the powder or dust adhering with the parts or main body of the machine.
7.5.6 Machine operator / worker will request Production Officer and QA Officer for checking visual inspection.
7.5.7 At first Production Officer will check the machine and its surroundings, then QA Officer will check the machine and its surroundings. If it found satisfactory result, then he / she will issue “Cleaned” label.
7.5.8 Keep the cleaned parts in dry and cool place and should be kept in the cupboard.
7.5.9
Record in Machine logbook (Annexure-I) and affix
the “Cleaned” label on the machine.
7.5.10
After cleaning the machine if it remains
without operation for next 72 hour, will undergo Re-cleaning operation.
8.0 Reference Document
8.1 In-house
9.0 Annexure
9.1 Annexure- I : Format of Machine Logbook
10.0 Revision History
|
Revision
No. |
Brief reason for the revision |
Effective Date |
Remarks |
|
01 |
New |
|
|
|
|
|
|
|
11.0 Training
11.1 Head of Production
or his nominee give the training of production operator and worker.
