Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.
Assalamu alaikum
Welcome to Our Presentation on
By…
MD. Waliulah Wali
Department of Pharmacy
Southeast University
waliseu31@gmail.com
https://www.facebook.com/pages/Warin...
Introduction
Production Department
Warehouse
Profile about Ziska Pharmaceutical Ltd.
Engineering department
Quality Assura...
Training Period:
From August 06, 2014 to August 19, 2014
Duration: 14 Days
Training Areas:
Warehouse
Production Department...
 In Bangladesh the pharmaceutical sector is one of the
most developed hi-tech sectors within the country's
economy.
 Thi...
 Company Name: Ziska Pharmaceutical Ltd.
 Factory Location: Karol Surichala, Safipur, Gazipur
 Head Office: Nurul tower...
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 8
In- Plant Training Program at ZISKA
PHARMACEUTICALS LTD.
2/10/2015 9
The Engineering department deals with the complete
maintenance of the production and companies total
working environment ....
Electricity:
Required electricity mainly obtained from DESA, incase of
load shedding heavy duty generator provide electric...
A boiler is used to boil water to
110◦C and produce steam for
production area.
Heat is generated by using gas.
Generated s...
It means Heating Ventilation Air Conditioning (HVAC). It
maintains optimum temperature and humidity throughout
the factory...
HVAC:
Controlling of temperature and Relative Humidity in deferent
areas-
 Dispensing: 22±2°C 45±5% RH
 Solid &Liquid: 2...
HVAC system:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Spoiled
Air
Back Filter
Added
with
natural air
Pre-f...
HVAC system:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 16
Chiller system:
This system is involved for the production of chilled water which is
supplied through the pipe to produce ...
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Chillers
2/10/2015 18
HEPA Filter
High-efficiency particulate air Filter or HEPA filter is an air
filter that must remove (from the air that pas...
HEPA Filter :
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 20
Environment Monitoring:
Environmental monitoring is one of the most important tasks in
the sterile department.
In- Plant T...
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Water
Portable water
Purified Water
Water for Injection
(WFI)
2/1...
Schematic Diagram of Purified Water and WFI Plant:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Feed
water
Alu...
Schematic Diagram of Purified Water and WFI Plant:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Reverse Osmosi...
Schematic Diagram of Purified Water and WFI Plant:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 25
Schematic Diagram of Purified Water and WFI Plant:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 26
Distillation Column :
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 27
WFI storage tank:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 28
Pharmaceutical unused chemicals & powders and waste
materials may cause severe harmful effect on environment
as well as hu...
Process Flow Chart of Effluent Treatment Plant (ETP)
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 30...
In- Plant Training Program at ZISKA
PHARMACEUTICALS LTD.
2/10/2015 31
 Warehouse is the place where the bulk raw materials,
packaging materials as well as finished products are kept
at their ...
Generally three types of labels are used in ware house.
They are-
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD....
Storage Condition:
Generally four Storage Condition are maintained according
do products sensitivity. These are:
2-8 oC
8-...
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 35
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 36
Tablets are solid dosage forms consisting of active
ingredient(s) and suitable pharmaceutical
excipients. They may vary in...
Name of Machine used in Tablet section:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
NAME OF MACHINE MODEL CAP...
The Tablet section performed the following steps to
manufacture a complete tablet dosage form.
In- Plant Training Program ...
1. Dispensing
It is one of the most important and the first step to
prepare any type of dosage form.
Purpose: -
To evaluat...
2. Granulation
Granulation is the process where the granules are
prepared from the powders.
Types:
A. Wet granulation
B. D...
A. Wet granulation
Steps:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Weighing
Granulating in
rapid mixing
gr...
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Double cone blenderFBDRMG
2/10/2015 43
Fluid Bed Processor
B. Dry granulation
Steps:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Requisition of raw materials
Weighing/D...
C. Direct compression
Steps:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Weighing of the
ingredients
Mixing &...
3.Compression:
Compression is the process to prepare tablet by
compacting the masses.
Purpose:
For the preparation of tabl...
TABLET COMPRESSION MACHINE(JAGUAR):
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 48
Compression Process :
Weighting of granules
↓
Put the materials into the hopper
↓
Filling of dies
↓
Tablet is prepared by ...
4.Coating
It is the process to put an outer surface or coat on
tablet. We observed the coating of “Ranitidine” tablet.
Pur...
Coating Process :
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Tablets to be coated is taken in coating pan
Te...
Coating Machine : Sejong
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 52
5.Packaging
Packaging is the last step of tablet section. It is the
process that protects product from environment (dust,
...
Blister packaging machine
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 54
Process of Blister Packaging:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
PVC
sheet
Heating (temp. 125
to 145...
Capsules are solid preparations with hard or soft shell of
various shapes and capacities, usually containing a single
dose...
Types of capsules:
1.Hard gelatin capsule
(double piece)
2.Soft gelatin capsule
(single piece)
In- Plant Training Program ...
Manufacturing process of Hard Capsule in Automatic
machine:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Empty...
Capsule filling Machine: Automatic
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
HUASHILI NJP- 2000
2/10/2015 59
Manufacturing process of Hard Capsule: Manual
Capsule shells are set into the plate through in setter
↓
Plate set into the...
Capsule filling Machine: Manual
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 61
This is a powder dosage form of oral drug used because the
drug is unstable in solution. It must be reconstituted
before u...
Process:
Milling and drying of sweetener
Transfer to a drum blender
Sieving and addition of active ingredients and other e...
A drug administer in solution is immediately available for
absorption and in most case is more rapidly and efficiently
abs...
Machineries Used in Filling & Packaging Unit of Liquid
department:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD...
Manufacturing Process of liquids:
Weighing of active ingredients along with excipients.
Excipients are mixed in a Charge v...
Filling & Sealing Machine: Pharmalab
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 67
Process of Liquid Filling:
Transfer of Prepared liquid preparation into the filling machine
from the processing vat by the...
Ointments are the soft semisolid preparations meant for
external application to the skin or mucous membrane.
Creams are vi...
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Water Phase Prepare in
Container (A).
Filling & Packaging
Transfe...
Sterile pharmaceutical products are very critical and
sensitive products. These products should be free from
living micro-...
Category of different parenteral processing area:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 72
Ar...
Clean room classification according to EUGGMP:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 73
Class...
Equipment used in Sterile Section
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Process Name of Equipment Capac...
Generally the products are manufactured by two ways:
Aseptically Sterilized: Products which must be processed
under asepti...
Flowchart showing the manufacturing of Parental
Product:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Aseptic
...
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 77
Quality Assurance is a wide ranging concept which covers
all matters which individually or collectively influence the
qual...
Function of Quality assurance:
1. Calibration and validation of testing equipment.
2. Sampling of incoming Raw materials, ...
In-process control for dosage form checked by QA
department:
Tablets
a) Dispensing : Room condition –Temperature and RH sh...
In-process control for dosage form checked by QA
department:
Capsules
Room condition, appearance of shell, average weight,...
In-process control for dosage form checked by QA
department:
Powder for suspension
a) Bulk Appearance, odor, color
b)Filli...
Various test involved in raw materials analysis:
1. Identification
2. Solubility
3. Appearance of the solution
4. pH
5. Me...
Apparatus used in QA Department:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
TABLET
HARDNESS
TESTER
ANALYTICA...
Apparatus used in QA Department:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
LOD MECHINE LEAK TESTER DISINTEG...
Quality control refers to the process of striving to produce
a perfect product by a series of measures to prevent or
elimi...
Equipment used in Quality Control Department:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Equipment Use
HPLC ...
Equipment used in Quality Control Department:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Equipment Use
Condu...
HPLC (High-performance liquid chromatography )
High-performance liquid chromatography (HPLC) is a
form of liquid chromatog...
Equipment used in Quality Control Department:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
UV-Visible Spectrop...
Equipment used in Quality Control Department:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Atomic-absorption S...
Equipment used in Quality Control Department:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
pH meter Melting Po...
Apparatus used in QC Department:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
DISSOLUTION
TESTER
2/10/2015 93
Microbiology laboratory is the part of quality control.
It has following responsibilities-
Microbial limit test (For bact...
Instruments used in Microbiology
1. Incubator (Memmert)
2. Incubator (Gallenkamp)
3. Biological safety cabinet class 2
4. ...
Activity of PD:
 Receive of raw materials for product development.
 Prepare lab batch.
 Develop and validation and rati...
Instruments used in this department:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
 Disintegration Tester
 Su...
In- Plant Training Program at ZISKA
PHARMACEUTICALS LTD.
2/10/2015 98
Packaging is the process by which the pharmaceuticals products
are suitably packed, in such way that they should retained ...
Type of Material used for packaging:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Primary packing
materials
1....
Diagrammatic Representation of packaging unit:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Packaging
Blister
...
Steps involved in blister packaging :
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Forming of Pocket
(By air P...
Blister packaging machine:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 103
Steps involved in strip packaging :
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
Formation of pocket of alumin...
Strip packaging Machine:
In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
2/10/2015 105
Every production biased company has a ware house. There
are two types of ware house. Finished product store is one
of them...
http://ziskapharmabd.com
https://www.google.com.bd/image
The Theory and Practice of Industrial Pharmacy by
Lachman.
http:/...
In- Plant Training Program at ZISKA
PHARMACEUTICALS LTD.
2/10/2015 108
In-plant Training Report  at Ziska Pharmaceuticals  Ltd. by~ Waliullah
Upcoming SlideShare
Loading in …5
×

In-plant Training Report at Ziska Pharmaceuticals Ltd. by~ Waliullah

8,878 views

Published on

ZISKA PHARMACEUTICAL LTD.
In Plant Training
Training Period: From August 06, 2014 to August 19, 2014 Duration: 14 Days

Training Areas:
Warehouse Production Department Quality Assurance & Quality Control Department Product Development Department Maintenance & Engineering Department
Introduction

In Bangladesh the pharmaceutical sector is one of the most developed hi-tech sectors within the country's economy.
This sector is also providing 97% 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.

PROFILE ABOUT ZISKA PHARMACEUTICAL LTD.

Company Name: Ziska Pharmaceutical 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

Popular Products OF ZISKA PHARMACEUTICAL LTD.
Engineering department
Engineering department
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.
Engineering department
Utility Service
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.

Engineering department
Engineering department
HVAC:
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.
Engineering department
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
Engineering department
HVAC system:


Engineering department
HVAC system:

Engineering department
Chiller system:
This system is involved for the production of chilled water which is supplied through the pipe to produce air conditioning system.
Process:

Engineering department











Engineering department
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 effi

Published in: Education
  • I would never forgive myself it i didn't give you one last opportunity to try the incredible Halki Diabetes Remedy for yourself!  http://ishbv.com/bloodsug/pdf
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here

In-plant Training Report at Ziska Pharmaceuticals Ltd. by~ Waliullah

  1. 1. Assalamu alaikum Welcome to Our Presentation on
  2. 2. By… MD. Waliulah Wali Department of Pharmacy Southeast University waliseu31@gmail.com https://www.facebook.com/pages/Warinas- Pharmaceuticals/245690832271163
  3. 3. Introduction Production Department Warehouse Profile about Ziska Pharmaceutical Ltd. Engineering department Quality Assurance Department Quality Control Department Packaging Department Finished Good
  4. 4. Training Period: From August 06, 2014 to August 19, 2014 Duration: 14 Days Training Areas: Warehouse Production Department Quality Assurance & Quality Control Department Product Development Department Maintenance & Engineering Department In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.
  5. 5.  In Bangladesh the pharmaceutical sector is one of the most developed hi-tech sectors within the country's economy.  This sector is also providing 97% 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. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.2/10/2015 6
  6. 6.  Company Name: Ziska Pharmaceutical 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 In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 7
  7. 7. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 8
  8. 8. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 9
  9. 9. 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. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 10
  10. 10. 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. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.2/10/2015 11
  11. 11. 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 In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 12
  12. 12. 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. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 13
  13. 13. 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 In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 14
  14. 14. HVAC system: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. Spoiled Air Back Filter Added with natural air Pre-filter Fine Filter Pass through Cold Water Coil Hepa Filter Fresh Air 2/10/2015 15
  15. 15. HVAC system: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 16
  16. 16. Chiller system: This system is involved for the production of chilled water which is supplied through the pipe to produce air conditioning system. Process: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 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 2/10/2015 17
  17. 17. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. Chillers 2/10/2015 18
  18. 18. 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%. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 19
  19. 19. HEPA Filter : In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 20
  20. 20. Environment Monitoring: Environmental monitoring is one of the most important tasks in the sterile department. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. Name of control measure Description Zone concept Class A(100),Class B(1000),Class C(10000),Class D(100000) (Ft³) Air pressure difference Positive pressure must be maintained in the processing room & 10- 15 Pascal higher than in the adjacent rooms. HEPA filter integrity 0.3 micron & 99.997% efficacy. Temperature & humidity (22 ±2)°C, (50±5) % Relative humidity. 2/10/2015 21
  21. 21. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. Water Portable water Purified Water Water for Injection (WFI) 2/10/2015 22
  22. 22. Schematic Diagram of Purified Water and WFI Plant: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. Feed water Alum dosing Sand bend Softener (strong cation resin) UV lamp (single) 254 nm 26 W Anti-scalant dosing NaOH dosing Cartridge filter 5µ RO-1 membrane 0.0001µ RO-2 membrane 0.0001µ 2/10/2015 23
  23. 23. Schematic Diagram of Purified Water and WFI Plant: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. Reverse Osmosis Storage Tank (1000L) Mixed Bed (strong cation & anion resin) Filter 132µ (Cartridge Net type) Filter 45 µ (Cartridge Net type) Cartridge filter 1µ Cartridge filter 0.2 µ UV lamp (double) 254 nm 26 W Purified Water tank (3000L) Multicolumn distillation WFI storage tank (500L) 2/10/2015 24
  24. 24. Schematic Diagram of Purified Water and WFI Plant: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 25
  25. 25. Schematic Diagram of Purified Water and WFI Plant: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 26
  26. 26. Distillation Column : In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 27
  27. 27. WFI storage tank: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 28
  28. 28. 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. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 29
  29. 29. Process Flow Chart of Effluent Treatment Plant (ETP) In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 30 Raw sewage from Cepha & Peni Neutralization (conc. NaOH) Sewage from production floor Bar screen chamber Equalization Tank Sewage transfer pump Primary clarifierAerotor BiozoneSecondary clarifier Chlorination tank (NaOCl dosing) Clarified Water Tank Treated sewage pump Multimedia Filter Carbon filter Discharge to Public sewer or recycle
  30. 30. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 31
  31. 31.  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 In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 32
  32. 32. Generally three types of labels are used in ware house. They are- In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. Passed Rejected 2/10/2015 33 Under test
  33. 33. Storage Condition: Generally four Storage Condition are maintained according do products sensitivity. These are: 2-8 oC 8-15 oC 15-25 oC ≤50 oC In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. Cool room 2/10/2015 34
  34. 34. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 35
  35. 35. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 36
  36. 36. 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. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 37
  37. 37. Name of Machine used in Tablet section: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 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 2/10/2015 38
  38. 38. The Tablet section performed the following steps to manufacture a complete tablet dosage form. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. Dispensing Granulation Compression Packaging Coating 2/10/2015 39
  39. 39. 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. To obtain standard dissolution, disintegration and other test done. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 40
  40. 40. 2. Granulation Granulation is the process where the granules are prepared from the powders. Types: A. Wet granulation B. Dry granulation C. Direct compression In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 41
  41. 41. A. Wet granulation Steps: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. Weighing Granulating in rapid mixing granulator(RMG) Drying in fluid bed dryer(FBD) Multi Milling Screening Lubrication (In Blender) Compression 2/10/2015 42
  42. 42. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. Double cone blenderFBDRMG 2/10/2015 43
  43. 43. Fluid Bed Processor
  44. 44. B. Dry granulation Steps: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. Requisition of raw materials Weighing/Dispensing Compression into slugs or roll compaction Milling and screening of slugs Lubrication/Blending 2/10/2015 45
  45. 45. C. Direct compression Steps: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. Weighing of the ingredients Mixing & Sieving according to desired mesh size Mixing with Lubricant CompressionTablet is prepared 2/10/2015 46
  46. 46. 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. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 47
  47. 47. TABLET COMPRESSION MACHINE(JAGUAR): In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 48
  48. 48. 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. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 49
  49. 49. 4.Coating It is the process to put an outer surface or coat on tablet. We observed the coating of “Ranitidine” tablet. Purpose: To mask the bitter and unpleasant taste Protect the ingredients from the environment Produce prolonged duration of action Increase pharmaceutical elegance In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 50
  50. 50. Coating Process : In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 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 2/10/2015 51
  51. 51. Coating Machine : Sejong In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 52
  52. 52. 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. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 53
  53. 53. Blister packaging machine In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 54
  54. 54. Process of Blister Packaging: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. PVC sheet Heating (temp. 125 to 145 C) Formation of pocket by air pressure Tablet or capsules are filled into the pocket automatically Sealing with aluminum top foil labeling & Batch Printing Auto feed checker Cutting 2/10/2015 55
  55. 55. 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. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 56
  56. 56. Types of capsules: 1.Hard gelatin capsule (double piece) 2.Soft gelatin capsule (single piece) In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 57
  57. 57. Manufacturing process of Hard Capsule in Automatic machine: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 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 2/10/2015 58
  58. 58. Capsule filling Machine: Automatic In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. HUASHILI NJP- 2000 2/10/2015 59
  59. 59. 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 In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 60
  60. 60. Capsule filling Machine: Manual In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 61
  61. 61. 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 In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 62
  62. 62. 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 In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 63
  63. 63. 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 In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 64
  64. 64. Machineries Used in Filling & Packaging Unit of Liquid department: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 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 2/10/2015 65
  65. 65. 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. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 66
  66. 66. Filling & Sealing Machine: Pharmalab In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 67
  67. 67. 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 In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.2/10/2015 68
  68. 68. 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. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 69
  69. 69. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. Water Phase Prepare in Container (A). Filling & Packaging Transferring &Weighing Milky Appearance Main Vessel (Mixing): stirring at 800Cfor 30min [High Speed=1500 rpm & low speed=43 rpm] Congealing For 1 Hour QA Approval Oil Phase Prepare in Container (B). 2/10/2015 70
  70. 70. 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) In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 71
  71. 71. Category of different parenteral processing area: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 72 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
  72. 72. Clean room classification according to EUGGMP: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 73 Class Particle count at rest m³ Particle count operation m³ Microbial growth (cfu) 0.5µ 5µ 0.5µ 5µ -- A 3500 0 3500 0 <1 B 3500 0 350000 2000 <5 C 350000 2000 3500000 200000 <50 D 3500000 20000 Not defined Not defined
  73. 73. Equipment used in Sterile Section In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 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 2/10/2015 74
  74. 74. 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 In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 75
  75. 75. Flowchart showing the manufacturing of Parental Product: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 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 2/10/2015 76
  76. 76. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 77
  77. 77. Quality Assurance is a wide ranging concept which covers all matters which individually or collectively influence the quality of a product. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. Quality Assurance Department Quality Control Documentation In Process Control Microbiology 2/10/2015 78
  78. 78. 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. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 79
  79. 79. 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 In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 80
  80. 80. 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. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 81
  81. 81. 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 In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 82
  82. 82. 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 In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 83
  83. 83. Apparatus used in QA Department: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. TABLET HARDNESS TESTER ANALYTICAL BALANCE FRIABILITY TESTER 2/10/2015 84
  84. 84. Apparatus used in QA Department: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. LOD MECHINE LEAK TESTER DISINTEGRATION TESTER 2/10/2015 85
  85. 85. 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 In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 86
  86. 86. Equipment used in Quality Control Department: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 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 2/10/2015 87
  87. 87. Equipment used in Quality Control Department: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 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 2/10/2015 88
  88. 88. 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. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 89
  89. 89. Equipment used in Quality Control Department: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. UV-Visible Spectrophotometer 2/10/2015 90
  90. 90. Equipment used in Quality Control Department: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. Atomic-absorption Spectrometer 2/10/2015 91
  91. 91. Equipment used in Quality Control Department: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. pH meter Melting Point Analyzer Karl Fischer titrator 2/10/2015 92
  92. 92. Apparatus used in QC Department: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. DISSOLUTION TESTER 2/10/2015 93
  93. 93. 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. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 94
  94. 94. 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) In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 95
  95. 95. 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. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 96
  96. 96. Instruments used in this department: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD.  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. 2/10/2015 97
  97. 97. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 98
  98. 98. 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 In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 99
  99. 99. Type of Material used for packaging: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 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 2/10/2015 100
  100. 100. Diagrammatic Representation of packaging unit: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. Packaging Blister Packaging Strip packaging Bottle filling/ Lose Packaging 2/10/2015 101
  101. 101. Steps involved in blister packaging : In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 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 2/10/2015 102
  102. 102. Blister packaging machine: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 103
  103. 103. Steps involved in strip packaging : In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. Formation of pocket of aluminum Filling Sealing Cooling Batch and expire number printing Cutting of strip 2/10/2015 104
  104. 104. Strip packaging Machine: In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 105
  105. 105. Every production biased company has a ware house. There are two types of ware house. Finished product store is one of them. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 106
  106. 106. http://ziskapharmabd.com https://www.google.com.bd/image The Theory and Practice of Industrial Pharmacy by Lachman. http://www.bdquery.com/details.php?c=1556 In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 107
  107. 107. In- Plant Training Program at ZISKA PHARMACEUTICALS LTD. 2/10/2015 108

×