In plant training at Ziska

1. 15/04/2019 1
Assalamu Alaikum
Welcome to My presentation
In-plant Training Report at
Ziska Pharmaceuticals Ltd.
NAME ID
ALI ASRAF SOHEL 2015000300008

2. 15/04/2019 2

3. Introduction
Profile about Ziska Pharmaceuticals Ltd
Warehouse
Production Department
 Assurance &Quality Control Department
Product Development Department ( Pd)
Packaging Department
Engineering department
Finished Good

4.  An in-plant training is a short duration training course which is
provided to the students for help them to correlate between
theoretical knowledge and their practical knowledge.
 In Bangladesh the pharmaceutical sector is one of the most
developed hi-tech sectors within the country's economy.
 This sector is also providing 98% of the total medicine
requirement of the local market.
 Recently few new industries have been established with
high tech equipment’s and professionals which will
enhance the strength of this sector.
 Ziska Pharmaceutical Ltd. is one of them.
15/04/2019 4

5.  Company Name: Ziska Pharmaceuticals Ltd.
 Factory Location: Karol Surichala, Safipur, Gazipur
 Head Office: Nurul tower, 34- Purana Paltan line,
Dhaka-1000
 Corporate Setup: Private Limited Company.
 Manufacturing areas: 146500 sft.
 Established Year: 1986
15/04/2019 5

6. 15/04/2019 6
Product list of Ziska pharmaceutical Ltd.
No Product Generic Name Pack Size
01 Acecol 100 Tab Aceclofenac 5x10's
02 Alfacort Inj. Triamcinolone
acetonide 1's
03 Altrum Gold Tab
(15's) Vitamin A to Z 15's
04 Analac Nasal
Spray
Ketorolac
Tromethamine 1's
05 Azithromax 500
Tab Azithromycin 2x5's
06 Azithromax PFS
35 ml Azithromycin 35 ml
07 Broxidil Syp Ambroxol
Hydrochloride 100 ml
08 Caldical-D Tab Calcium + Vitamin-D 5x10's
09 Cefadin 1g IV/IM
Inj. Cephradine 1's
10 Cefadin 500 Cap Cephradine 7x4's

7. 15/04/2019 7

8. 15/04/2019 8

9.  Warehouse is the place where the bulk raw materials,
packaging materials as well as finished products are kept
at their optimum storage condition.
 Raw materials and packaging material are tested as they
enter the warehouse and they are transferred to the
manufacturing department by requisitions.
 The storage department of Ziska Pharmaceuticals Ltd.
includes the following sections:
1. Raw materials store
2. Packing material store and
3. Finished product store
15/04/2019 9

10. 15/04/2019 10
Rejected
On hold
Released
Under test/ Sampling
Quarantine
Generally five types of labels are used in ware house.
They are-

11. Storage Condition:
Generally four Storage Condition are maintained according
to products sensitivity. These are:
2-8 oC
8-15 oC
15-25 oC
≤50 oC
15/04/2019 11
Cool room

12. 1215/04/2019

13. 15/04/2019 13

14. Tablets are solid dosage forms consisting of active
ingredient(s) and suitable pharmaceutical excipients. They
may vary in size, shape, weight, hardness, thickness,
disintegration and dissolution characteristics.
15/04/2019 14

15. Name of Machine used in Tablet section:
15/04/2019 15
NAME OF MACHINE MODEL CAPACITY ORIGIN
Rapid Mixer Granulator Saral Eng. 100kg/80L India
Fluidized Bed dryer(FBD) Alliance 60 kg India
Fluid Bed Processor (FBP) Solate 250kg Korea
Multi Mill Shifter Kothari Pharma 60kg/hr India
Double Cone Blender (DCB) Mark Inds. 150kg Bangladesh
Tablet compression machine 35 S Jaguar 60rpm India
Tablet compression machine 27 S Cadmach 50rpm India
Automatic Film coating machine Intilligent 60-80kg China
Blister machine Buchon 28rpm Korea

16. The Tablet section performed the following steps to
manufacture a complete tablet dosage form.
Dispensing
Granulation
Compression
Packaging
Coating
1615/04/2019

17. 1. Dispensing
It is one of the most important and the first step to
prepare any type of dosage form.
Purpose: -
 To evaluate the correct quantity of drug and
excipients .
 To prepare an unit dosage form.
15/04/2019 17

18. 2. Granulation
Granulation is the process where the granules are
prepared from the powders.
Types:
1. Wet granulation
2. Dry granulation
3. Direct compression
15/04/2019 18

19. A. Wet granulation
Steps:
15/04/2019 19
Weighting
Granulating in
rapid mixing
granulator(RMG)
Drying in
fluid bed
dryer(FBD)
Multi Milling Screening
Lubrication
(In Blender)
Compression

20. 15/04/2019 20
Double cone blenderFBDRMG

21. 15/04/2019 21
Fluid Bed Processor

22. 2215/04/2019

23. C. Direct compression
Steps:
15/04/2019 23
Weighting of the
ingredients
Mixing & Sieving according
to desired mesh size
Mixing with
Lubricant
CompressionTablet is prepared

24. 15/04/2019 24
At A Glance of Granulation

25. 3.Compression:
Compression is the process to prepare tablet by
compacting the masses.
Purpose:
For the preparation of tablet
To prepare accurate uniformity and tablet
dosage form.
2515/04/2019

26. Compression Process :
Weighting of granules
↓
Put the materials into the hopper
↓
Filling of dies
↓
Tablet is prepared by compression between the rotating area of
punch and dies
↓
Ejection
↓
Checking size, shape and hardness, thickness, D.T, Friability of
the tablet.
15/04/2019 26

27. 4.Coating
It is the process to put an outer surface or coat on
tablet. We observed the coating of “Cortan” tablet.
Purpose:
To mask the bitter and
unpleasant taste
Protect the ingredients from the environment
Produce prolonged duration of action
Increase pharmaceutical elegance
15/04/2019 27

28. Coating Process :
Tablets to be coated is taken in coating pan
Temp. of pan, inlet & outlet air pressure, RPM of pan etc are
adjusted
Solution is connected to machine by tubes
Solution is sprayed onto the tablets by spray guns of the
machine.
Coating
2815/04/2019

29. Coating Machine : Sejong
15/04/2019 29

30. 5.Packaging
Packaging is the last step of tablet section. It is the
process that protects product from environment (dust,
foreign particles etc.) during distribution, storage, sale
and use.
Purpose
To provide convenience to user.
To ensure satisfactory sealing.
15/04/2019 30

31. Blister packaging machine
15/04/2019 31
Blister packaging machine

32. Capsules are solid preparations with hard or soft shell of
various shapes and capacities, usually containing a single
dose of active substance(s).They are intended for oral
administration.
3215/04/2019

33. Types of capsules:
1.Hard gelatin capsule
(double piece)
2.Soft gelatin capsule
(single piece)
15/04/2019 33

34. Manufacturing process of Hard Capsule in Automatic
machine:
Empty
capsule
shell
Shells in
hopper
Caps and bodies are separated
by the force created by vacuum
pressure
powder are automatically filled
in body of shell
Enclosing
of cap and
body
Ejection
Finishing Inspection Packaging
3415/04/2019

35. Capsule filling Machine: Automatic
15/04/2019 35
HUASHILI NJP- 2000

36. Manufacturing process of Hard Capsule: Manual
Capsule shells are set into the plate through in setter
↓
Plate set into the hand filler
↓
Body and cap separated by scissor
↓
Fill the body with materials
↓
Attached body and cap
↓
Capsules
15/04/2019 36

37. Capsule filling Machine: Manual
15/04/2019 37

38. This is a powder dosage form of oral drug used because the
drug is unstable in solution. It must be reconstituted
before use. It is mainly sugar based preparation.
We observed the preparation of Quinitor dry syrup
(Ciprofloxacin).
Purpose:
For the easy administration of drugs
To obtain the effectively of the drug completely after
reconstitution
15/04/2019 38

39. Process:
Milling and drying of sweetener
Transfer to a drum blender
Sieving and addition of active ingredients and other excipients
Proper mixing
Bottle filling and sealing
15/04/2019 39

40. A drug administer in solution is immediately available for
absorption and in most case is more rapidly and efficiently
absorbed than the same amount of drug administered in
tablet and capsules.
In Liquid processing unit two types of liquid dosage form
are manufactured. This are-
1. Syrup
2. Suspension
15/04/2019 40

41. Process of Liquid Filling:
Transfer of Prepared liquid preparation into the filling machine
from the processing vat by the use of transfer pump.
Set the machine according to filling volume
Filling of bottles
Sealing of bottle using sealing machine
Labeling & Packaging of bottles
15/04/2019 41

42. Machineries Used in Filling & Packaging Unit of Liquid
department:
NAME OF MACHINE MODEL CAPACITY
Bottle washing machine Laxmipharma 100-120
bottle/min
Bottle washing machine Pharmalab 100-120
bottle/min
Bottle filling & Cap locking machine Pharmalab 100 bottles/min
Bottle filler & Capper machine United 80bottles/min
Bottle filler & Capper machine Kingfisher 70bottles/min
Bottle labeling machine Ambica 110-150 label/min
Syrup Mixing Machine Silverson Mixer 3000L
4215/04/2019

43. Manufacturing Process of liquids:
Weighing of active ingredients along with excipients.
Excipients are mixed in a Charge vessel
Active is added to the vessel & mixed
Passing through a Pump to the storage vessel
Transfer of the solution to the filling vessel through 0.5µ Cartridge filter
Filling, Flushing of Nitrogen (N2) & Sealing of Bottles containing oral
liquid.
15/04/2019 43

44. Filling & Sealing Machine: Pharmalab
4415/04/2019

45. Ointments are the soft semisolid preparations meant for
external application to the skin or mucous membrane.
Creams are viscous semisolid ointment like preparation
but have lighter body than the ointment. Due to the
presence of water soluble base in oil in water type creams
they can be easily removed from the skin.
15/04/2019 45

46. 15/04/2019 46
Water Phase Prepare in
Container (A).
Filling & Packaging
Transferring
&Weighing Milky Appearance
Main Vessel (Mixing): stirring
[High Speed=1500 rpm & low speed=43 rpm]
Congealing For 1 Hour
QA Approval
Oil Phase Prepare in
Container (B).

47. Sterile pharmaceutical products are very critical and
sensitive products. These products should be free from
living micro-organisms, pyrogen and unacceptable
particulate matter.
Parenteral products are radically different from other
dosage form in terms of standards of purity and safety.
Type of dosage form of sterile product:
1. Ophthalmic
2. Injectable
3. Powder for injection(Vial)
4715/04/2019

48. Category of different parenteral processing area:
48
Area Clean room standard
Filling point 100 class A
Filling room 1000 class B
Vial washing & sterilization room 10,000 class C
Filling room corridor 10,000 class C
Dress change room 10,0000 class D
15/04/2019

49. Equipment used in Sterile Section
Process Name of Equipment Capacity
Vial washing Ambico Wash Machine(India) 1000-1200/hr.
Dry Heat Sterilization Hot air Oven (India) 40 Trays
Steam Heat Sterilization Autoclave (India) 40 Trays
Dry Heat Sterilization Ampoules Dry Heat sterilizer (Pakistan) 30 Trays
Vial Filling & sealing Automatic Vial filling & Sealing
Machine
30-40 vials/min
Solution Processing Solution Processing SS vessel (Germany) 500L for SVPL
Veterinary solution
processing
SS Vessel for Veterinary solution
(Germany)
100-500L
4915/04/2019

50. Generally the products are manufactured by two ways:
Aseptically Sterilized: Products which must be processed
under aseptic conditions.
Terminally Sterilized: Products which can be sterilized in
their final container
5015/04/2019

51. Flowchart showing the manufacturing of Parental
Product:
15/04/2019 51
Aseptic
dispensing
Mixing in the
100L/500L
manufacturing
vessel
Filtration is
done using
1.2µm and
0.2µm cartridge.
Filling in Filling
and sealing
Machine
Autoclave at
121°C for 30
minutes in the
autoclave
Packaging

52. 15/04/2019 52

53. 15/04/2019 53
Quality Assurance Department
Quality
Control
Documentation
In Process
Control
Microbiology
 Quality assurance is the sum total of the
organized arrangements made with the object
of
QA = Product design + GMP + QC + Quality
goal activities.

54. Function of Quality assurance:
1. Calibration and validation of testing equipment.
2. Sampling of incoming Raw materials, In process
Analysis, Finished Product & Packaging Materials
Analysis.
3. Working Environmental Analysis.
4. Review of Stability Date and Shelf Life of Products.
5. Review of Product Design (Label & Formula).
6. Review of batch production and quality control records
and release of products.
7. Physical Inspection at random before release of a batch
of Finished Product.
15/04/2019 54

55. In-process control for dosage form checked by QA
department:
Tablets
a) Dispensing : Room condition –Temperature and RH should be within
limit.
b) Granulation: Uniformity of the granules as well as granule size.
c) Drying: LOD (Loss on drying).
d) Compression: Room condition, appearance of tablets , Average weight,
uniformity of weight, hardness, thickness and diameter of the tablet.
Friability of the tablet as well the disintegration time is also checked.
e) Coating: Absence of bridging, filling, sticking, color variation
15/04/2019 55

56. In-process control for dosage form checked by QA
department:
Capsules
Room condition, appearance of shell, average weight, uniformity
of weight, disintegration time.
Liquid dosage forms, Ointment, creams, gels
a) Appearance, odor, color and pH
b) Filling: Fill weight; fill volume, sealing, presence of foreign
materials.
15/04/2019 56

57. In-process control for dosage form checked by QA
department:
Powder for suspension
a) Bulk Appearance, odor, color
b)Filling: Room condition, fill weight, reconstituted
volume, sealing of cap.
Packaging
Blistering, PP infusion bags : Leak test
15/04/2019 57

58. Various test involved in raw materials analysis:
1. Identification
2. Solubility
3. Appearance of the solution
4. pH
5. Melting point limit
6. Loss on drying
7. Bulk destiny
8. IR spectroscopy
9. UV spectroscopy
10. HPLC
11. Water content
12. Potency determination
13. Microbiological test
15/04/2019 58

59. Apparatus used in QA Department:
15/04/2019 59
TABLET
HARDNESS
TESTER
ANALYTICAL
BALANCE
FRIABILITY
TESTER

60. Apparatus used in QA Department:
15/04/2019 60
LOD MECHINE LEAK TESTER DISINTEGRATION TESTER

61. Quality control refers to the process of striving to produce
a perfect product by a series of measures to prevent or
eliminate errors in production.
Functions:
Quality control department has functions in the following
areas:
Documentations.
Raw materials.
Finished products.
Packaging materials
15/04/2019 61

62. Equipment used in Quality Control Department:
15/04/2019 62
Equipment Use
HPLC (High-
performance liquid
chromatography )
Analytical Test:
 Identification
 Qualification
 Separation
Atomic absorption
spectrophotometer
To identify and measure minerals.
IR Spectrophotometer Material identification & purity tests
UV-Visible
Spectrophotometer
Determination of impurities in
organic molecules
Gas Chromatography A wide range analytical test

63. Equipment used in Quality Control Department:
15/04/2019 63
Equipment Use
Conductivity Tester To test conductivity
Viscometer Viscosity determination
pH meter To determine pH
Dissolution Tester Dissolution testing
Melting Point Analyzer Identification
LOD Tester To determine moisture content
Weighing Balance Analytical weighing
Potentiometry titrator Potentiometric titration for ions
Karl Fischer titrator Moisture determination

64. HPLC (High-performance liquid chromatography )
High-performance liquid chromatography (HPLC) is a
form of liquid chromatography to separate compounds
that are dissolved in solution & also used to ensure the
purity of raw materials.
15/04/2019 64

65. Equipment used in Quality Control Department:
15/04/2019 65
UV-Visible Spectrophotometer

66. Equipment used in Quality Control Department:
15/04/2019 66
Atomic-absorption Spectrometer

67. Equipment used in Quality Control Department:
15/04/2019 67
pH meter Melting Point
Analyzer
Karl Fischer titrator

68. Apparatus used in QC Department:
15/04/2019 68
DISSOLUTION
TESTER

69. Microbiology laboratory is the part of quality control.
It has following responsibilities-
Microbial limit test (For bacteria and fungi).
Antibiotic assay.
Microbial content of environment.
15/04/2019 69

70. Instruments used in Microbiology
1. Incubator (Memmert)
2. Incubator (Gallenkamp)
3. Biological safety cabinet class 2
4. Shaking water bath
5. PH meter
6. Kinetic LAL analyzer
7. Dynamic pass box
8. Autoclave
9. Sterilizing oven
10. TOC (total organic carbon analyzer)
11. LPC (liquid particle counter)
15/04/2019 70

71. Activity of PD:
 Receive of raw materials for product development.
 Prepare lab batch.
 Develop and validation and rationale.
 Prepare final formulation & rationale.
 Prepare pilot batches.
 Perform initial studies.
 Put samples on storage conditions.
 Perform 01 month study.
 Prepare content of shelf-life.
15/04/2019 71

72. Instruments used in this department:
15/04/2019 72
 Disintegration Tester
 Suction Pump
 Drying Oven
 Refrigerator
 Hardness Tester
 Shaker
 IR Moisture Balance
 Analytical Balance
 Dissolution Tester
 Friability Tester
 PH Meter
 Melting Point Apparatus
 Hot plate Stirrer
 Karl Fischer titrator
 UV Visible Spectrophotometer
 HPLC
Product development department also use QC lab., production
department and SVP department for their test purposes.

73. 15/04/2019 73

74. Packaging is the process by which the pharmaceuticals products
are suitably packed, in such way that they should retained their
therapeutic effectiveness from the time of their packaging to
consume by the consumers and it also helps to withstand the
stress during transport.
Ziska Pharmaceuticals Ltd. has a well-established packaging
department.
There are mainly two types of packing materials:
1. Primary packing materials
2. Secondary packing materials
15/04/2019 74

75. Type of Material used for packaging:
15/04/2019 75
Primary packing
materials
1. Alu Foil (Blister/Strip)
2. PVC/PVDC Film
3. Alu Bottom Foil
4. Bottle
5. P.P. Cap
6. Unit Carton
7. Vial
8. Ampule
9. Rubber stopper
Secondary packing
materials
1. Box/ Inner carton
2. Insert
3. Label
4. Flipoffseal
5. Plastic Spoon/ Dropper
6. Cup
7. Stopper
8. Master Carton
9. Shipper cartoon
10. Hologram sticker
11. Honey com

76. Diagrammatic Representation of packaging unit:
15/04/2019 76
Packaging
Blister
Packaging
Strip
packaging
Bottle filling/
Lose
Packaging

77. Steps involved in blister packaging :
15/04/2019 77
Forming of Pocket
(By air Pressure &
temperature)
Filling Station
(Channel/ Feeder /
dosage Cannel)
Sealing
(Temperature
Station)
Cooling
Rejection of
empty
Blister Pack
Collection
of Blister
Pack
Send for
Secondary
Packaging

78. Blister packaging machine:
15/04/2019 78

79. Steps involved in strip packaging :
15/04/2019 79
Formation of pocket of aluminum
Filling
Sealing
Cooling5
Batch and expire number printing
Cutting of strip

80. Strip packaging Machine:
15/04/2019 80

81. 15/04/2019 81

82. The Engineering department deals with the complete
maintenance of the production and companies total
working environment .
The Engineering section of Ziska Pharmaceuticals Ltd.
covers the following Utilities :
Production machineries.
Electricity supply
Air Handling
Water supply
Emergency supply
Repairing, restoring and reporting
Worker distribution and pest control.
15/04/2019 82

83. Electricity:
Required electricity mainly obtained from DESA, incase of
load shedding heavy duty generator provide electricity.
Generator:
Name: Cummins
Type: diesel operated.
Capacity: 1750 kilowatt.
Requirement: 1500 kilowatt.
15/04/2019 83

84. A boiler is used to boil water to
110◦C and produce steam for
production area.
Heat is generated by using gas.
Generated steam is used in fluid
bed dryer, FBP and in coating pan.
Name: Fulton (Tube less boiler)
Origin: America
15/04/2019 84

85. It means Heating Ventilation Air Conditioning (HVAC). It
maintains optimum temperature and humidity throughout
the factory.
All seeks to provide thermal comfort , acceptable indoor air
quality and reasonable installation operation.
15/04/2019 85

86. HVAC:
Controlling of temperature and Relative Humidity in deferent
areas-
Dispensing: 22±2°C 45±5% RH
Solid &Liquid: 22±2°C 55±5% RH
Sterile: 22±2°C 50±5% RH
Low humidity requiring rooms: 22±2°C 25±5% RH
Minimum air change rate:
Class B 30/hr
Class C 30/hr
Class D not less than 15/hr
15/04/2019 86

87. HVAC system:
15/04/2019 87
Spoiled
Air
Back Filter
Added
with
natural air
Pre-filter
Fine Filter
Pass through
Cold Water
Coil
Hepa
Filter
Fresh Air

88. HVAC system:
15/04/2019 88

89. Chiller system:
This system is involved for the production of chilled water which is
supplied through the pipe to produce air conditioning system.
Process:
15/04/2019 89
Fan
Chilled water
supplied through
coil
Air flow inhibitor,
which hold air and
helps to remain with
the contact of coil
and cool them
Conditioned air

90. 15/04/2019 90
Chillers

91. HEPA Filter
High-efficiency particulate air Filter or HEPA filter is an air
filter that must remove (from the air that passes through)
99.97% of 0.3 µm size particles.
Smaller and larger particles are filtered at even greater
efficiency.
The efficiency of H30 HEPA filter is about 99.99% and
The efficiency of H40 HEPA filter is about 99.999%.
15/04/2019 91

92. HEPA Filter :
15/04/2019 92

93. 15/04/2019 93
Water
Portable water
Purified Water
Water for Injection
(WFI)

94. Schematic Diagram of Purified Water and WFI Plant:
15/04/2019 94

95. Schematic Diagram of Purified Water and WFI Plant:
15/04/2019 95

96. WFI storage tank:
15/04/2019 96

97. Pharmaceutical unused chemicals & powders and waste
materials may cause severe harmful effect on environment
as well as human health.
An Effluent Treatment Plant (ETP) manages or treats the
waste materials into neutralized molecule or reduces the
harmful ingredients below toxic concentration.
15/04/2019 97

98. Every production biased company has a ware
house. There are two types of ware house.
Finished product store is one of them.
9815/04/2019

99. 15/04/2019 99
• For a pharmacy student a learning combination
of theory and practice is an invaluable asset
which helps in understanding the core meaning
of pharmacy by way of first-stand experience.
• Subject like pharmacy demands practical
knowledge of its own field.
• Thus industrial training program is one of most
important parts of a student studying in a subject
like pharmacy.
Conclusion

100. THANK
YOU
10015/04/2019