Pharmaceuticals in plant training presentation by Don

In-Plant
Training
Presentation
Special Thanks to -Special Thanks to -

In-Plant Training Presentation
In-Plant Training at Orion Pharma Ltd.
Presented by:
Md. Mehedi Hasan Don
Id: 2015000300060
Student of - Trainee of -

Introduction about Plant
Departments which we visited
Description about these departments
Conclusion
1
2
3
4
What to Explain:

Introduction about Orion Pharma

• ORION Pharma Ltd. is one of the premier pharmaceutical companies of
Bangladesh
• Awarded with the ISO-9001: 2000 Certificate in January 2003
• Achieved the recommendation of UNICEF as a “Potential Medicine Supplier of
UNICEF”.
• Orion has now more than 200 generics in a wide range of dosage form and
strengths including life-saving injectables.
• Orion export more than 12 countries including Nepal, Myanmar, Afghanistan,
Vietnam, Cambodia, Srilanka, Pakistan, Yemen, Singapore and some African
Countries.
Introduction about Orion Pharma

Popular Products of Orion Pharma

Production:Production: TabletTablet
• Pharmaceutical solid unit dosage form of medicament or medicaments with or without
suitable excipients and prepared either by molding or by compression
• Active substances and excipients, usually in powder form
• Pressed or compacted from a powder into a solid dose

OxyContin use by 8th graders doubled in last 4 years
The Tablet section performed the following steps to
manufacture a complete tablet dosage form.

Dispensing:
•Material is dispensed by the stores as follows:
• Raw malarial:
• (only if all the raw material for the batch are available)
• Raw material Dispensing Quantity cannot be modified at any paint of time
• Dispensing following
• the FIFO pattern taking into account the materials control no and
expiry date
• Quantity based on the specification of the material required for the
production
• Quantity based on Potency and Purity of material
• Packing material:
• Quantity Is as per the actuals from the master formula, but can be altered
to suit the available size

GranulationGranulation
•Granulation is the process in which primary powder particles are made to adhere to form larger,
multi—particle entities called granules.
• It is the process of collecting particles together by
creating bonds between them.
• Bonds are formed by compression or by using a
binding agent.
• Granulation is extensively used in the
manufacturing of tablets and pellets.

Flowchart of Dry Granulation Process

Step 1: Weighing and Blending
Step 2: wet granulate prepared by adding the binder solution
Step 3: Screening the damp mass into pellets or granules (6-Smesh)
Step 4: Drying the granulation in thermostatically controlled oven
Step 5: Dry screening:
Step 6: Mixing with other ingredients: A dry lubricant, anti adherent and glidant is added to the
granules either by dusting over the spread-out granules or by blending with the granules. Dry
binder, colorant or disintegrant may be also added in this step.
Step 7: Tableting: Last step in which the tablet is fed into the die cavity and then compressed.
Wet Granulation processWet Granulation process

Flowchart of Wet Granulation Process

Direct Compression

Machine Used in Granulation
Figure: Rapid Mixer Granulator

Fluid Bed Dryer Bin Blender

Compression
Principle of Tablet Compression Machine:
•compressing of the upper and lower punch in a die hole, the hydraulic pressure
plays a key role.
•This pressure is transmitted unreduced through the static fluid.
•Applied pressure is transmitted via static fluid to all the direction in same
proportion.
•It also makes it possible to multiply the force as needed.
•Increase the compressing force on tablet then it becomes more hard.

Tablet compressing stage
Filling: Formulation is overfilled at the compressing station
Metering: Overfill is removed
Compression: Tablet is formed by pressure of punches within die
Ejection: Tablet is ejected from die

Tablet Compression Process

Flowchart of tablet compression

Tablet Compression machine

CAPPING:
Partial or complete separation of the top or bottom of tablet due to air-entrapment in the
granular material.
LAMINATION
Separation of tablet into two or more layers due to air entrapment in the granular material.
CRACKING
Small. ﬁne cracks observed on the upper and lower central surface of tablets or very rarely
on the sidewall.
CHIPPING
Breaking of tablet edges.
Problems of tableting

Tablet Coating
Coating is an art, where-
•a film is produced on tablets surface to
masking taste, odor
•to increase aesthetic properties
•to prevent moisture penetration and
•to modify drug release pattern.

Types of coating
There are four types of coating:
•Film coating
• Polymer Used: HPMC
•Seal Coating
• Polymer Used: Eudragit L 100, Kollidone VA 64
•Enteric coating
• Polymer Used: HPMC thalate
•Sugar coating

Tablet Coating Process

Tablet Coating Machine

Production:Production: CapsuleCapsule
Capsules are a solid dosage form in which the drug substance is enclosed in
a water soluble shell or an envelope.
A capsule shell is made from gelatin.
Capsule

Types of Capsule

Parts & Size of Capsule Shell

Filling Process of Hard Gelatin Capsule

Capsule Filling Machine
Automatic
Manual

Production:Production: PFSPFS
An intimate mixture of dry, finely divided drugs and/or chemicals, which,
upon the addition of suitable vehicles, yields a suspension (a liquid
preparation containing the solid particles dispersed in the liquid vehicle).
Powder for Suspension
Dry Syrup
Dry syrups are powder mixtures that Dry syrups are powder mixtures that
require the addition of water require the addition of water (reconstitution) at
the time of dispensing(reconstitution) at the time of dispensing and are
mostly for pediatric use.

Process of manufacturing PFS

Machine used in manufacturing PFS
Double Cone Blender

Production:Production: LiquidLiquid
Liquid preparations for oral use are usually solutions, emulsions or suspensions
containing one or more active ingredients in a suitable vehicle; they may in some
cases consist simply of a liquid active ingredient used as such.
In Liquid processing unit two types of liquid dosage form are manufactured. This
are-
1.Syrup
2.2. Suspension
liquid preparation

Manufacturing Process of liquid preparation

Manufacturing vessel Stirrer

Automatic Filling & sealing Machine

Production:Production: Cream & OintmentCream & Ointment

Cream Ointment manufacturing plant

Automatic Tube filling &
sealing machine

Production:Production: Sterile SectionSterile Section
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)

Production:Production: Sterile SectionSterile Section

PPIC-PPIC- Product PlanningProduct Planning
Inventory ControlInventory Control

PPIC-PPIC- Product Planning Inventory ControlProduct Planning Inventory Control
 PPIC stands for Production Planning & Inventory Control.
 PPIC is a part of the corporate organization that bridges the 2 department ie: marketing &
production.
 PPIC translate procurement requirements for the marketing of finished products into the
form of production plan & availability of raw materials and packaging materials.
 PPIC so important role in the company's operations because it is closely related to "cash
flow / flow of funds" & performance of the production in general.

PPIC function
1. Synergy to the marketing and manufacturing interests
2. Integrate / incorporate the parties in the organization (marketing, production, personnel,
and financial) in order to work properly.
PPIC-PPIC- Product Planning Inventory ControlProduct Planning Inventory Control

Research & DevelopmentResearch & Development
DepartmentDepartment

Research = basic experimental research
•Eg identification of possible chemical compounds.
•Theoretical mechanisms
•Universities
Development = exploitation of discoveries
•Mainly private sector
•Proof of concept
•Safety testing (eg drugs).
•Delivery mechanism (eg how to administer a drug)
Research & Development DepartmentResearch & Development Department

Research and development department deals with the following
functions
• New product formulation
• Reformulation
• Reprocess
• Trouble shooting
• Preparation of BPR for a new product
• Development of existing product

Development of a new product
Step-1: Product information from marketing department along with necessary attributes
Step-2: Pre-formulation study of the active drug and excipient.
Step-3: Collection of raw materials of active drug and excipients from TSD department.
Step-4: Different trials for development of a stable, effective and active formulation.
Step-5: Drug administration formalities include:
Step-6: Pilot trial and accelerated stability testing.
Step-7: Readjustment If necessary.
Step-8: BMR preparation if every aspect is satisfied which contains
Step-9: Transfer to commercial production.

Development of existing products
Research and development department also deals with the development of
existing product formulation.
Objective:
• Increasing the quality of the product.
• Prevention of any type of problem existing in the product.
• To save time and cost.
• Increasing the patient acceptance.

Accelerated stability testing for pharmaceutical products
♦ Environmental condition
Temperature
(°C)
Humidity
(%)
Type of product
25 60 Solid & dry
powder
40 75 Solid & dry
powder
40 & 45 Not
controlled
Liquid
Ambient Ambient For all products
♦ Life time of product determination
If meet all specifications, then the shelf-
life of products is given according to
the following table.
Accelerated stability
test time
Equivalent life time
6 months 2 years
3 months 1½ years

Stability Testing
oMarketed product
For marketed product at least one product from each batch is stored in ambient condition. The
stability of the product is tested after a certain frequency which may be 0,3,6 ,9 …. months and so
on.
oNew product
Accelerated condition: temperature 45C humidity+75%. If the new drug remain stable in this
condition for six months then gives two years shelf life for those drugs.
Ambient condition: New drugs are kept in normal room temperature and humidity. Drugs are
tested after every three months.

Quality AssuranceQuality Assurance

• Quality Assurance (Q.A) is the sum total of organized arrangements made
with the object of ensuring that product will be of the quality required by
their intended use.
• Quality assurance is the systematic monitoring and evaluation of the
various aspects of a project, service or facility to maximize the probability
that minimum standards of quality are being attained by the production
process.
• QA cannot absolutely guarantee the production of quality products.

• Dispensing checking
• In-processtesting
• SOP designing
• Workers training
• Validation
• Self inspection / internal audit
• Art work
• Market return
Role of Quality Assurance in industryRole of Quality Assurance in industry
• Temperature check
• Humidity checking
• Line clearance (at different stages, in line clearance our
focus is on cleanliness proper identification of
productbatch No. packing procedure, productlabeling)
• Stability testing
• Maintain record
• Dispatch testing
• Handling of market complains

Quality assurance Department
Quality Control Documentation In process
Quality Control
Microbiology
Raw materials Q.C Finished Product Q.C Packaging materials Q.C
Solid productsLiquid products

• Appearance(color, size, shape)
• Wt. variation
• 80 mg o <± 10 %
• 80 – 250 mg ±7.5% >
• 250mg ± 5%
• Average wt.
• Disintegration
In-process test for Tablets
• Hardness
• Thickness
• Diameter
• Dissolution time
• Friability test
Wt. before=A
Wt. after= B
Q.A perform following test for in-process testing of tablets

In-process test for Capsule
•Physicalappearance
•Disintegration test
•Averagewt.
•Wt. Variation
• 350 mg or <± 10 %
• 350 mg or <± 7.5 %

In-process test for Liquid Preparation
•pH
•Viscosity
•Weight per ml
• Wt. of empty pychno-meter = A
• Wt. of pychno-meter + liquid/ suspension =B
• Wt of liquid/ suspension =B – A =C
•Deliverable volume

Documentation
The documentation aspect of QA is broad and varied. A well-run company
has a clear paper trail for every aspect of production. The following are
some of the documents maintained by the QA department.

Regulations: QA is responsible for all documents demonstrating compliance
with federal and state regulations relevant to the product.
Training: QA is responsible for all documents pertaining to personnel training.
QC records: QA is responsible for all documents pertaining to the quality
control testing of the company’s products.
Quality Audits: QA is responsible for all documents pertaining to quality
audits.
Procurement: QA will often develop lists of approved vendors.

Machines Used in QA Department

Quality ControlQuality Control

Quality Control DepartmentQuality Control Department
• Qc is the part of GMP concerned with
• sampling,
• specifications and
• testing and
• with the organization,
• documentation and
• release procedures
• which ensure that the necessary and relevant tests are actually carried out and
• The materials are neither released for use nor products are used for sale & supply until
their quality has been satisfactory.

• Quality control is an essential operation of the pharmaceutical industry.
• Drugs must be marketed as safe and therapeutically active formulations whose performance is
consistent and predictable.
• New and better medicinal agents are being produced at an accelerated rate. At the same time more
exacting and sophisticated analytical methods are being developed for their evaluation.
• The 4 Main responsibilities of quality control in pharmaceutical industry include :
• Efficacy
• Safety
• Quality
• Compliance
Role of quality control in pharmaceutical industry

• Quality Control in the pharmaceutical industry is required for :
• Raw Materials and API:
• The techniques used include Raman and IR spectroscopy, Assay( HPLC and
Titration ), Physical tests.
• Packaging Components :
• The various packaging components which are in contact with the drug are
tested. The techniques include appearance, spectroscopy, loss on drying.
• Finished Products :
• The techniques include HPLC, Assay, Dissolution, Content uniformity.

Instruments Used in Quality Control Area

HPLC: High Pressure Liquid Chromatography

FTIR: Fourier-transform infrared spectroscopy

UV visible spectroscopy

Atomic absorption spectroscopy (AAS)

Engineering Department
The Engineering department deals with the complete maintenance of the production and companies
total working environment .
The Engineering section of Orion Pharma Ltd.
covers the following Utilities :
• Production machineries.
• Electricity supply
• Air Handling
• Water supply
• Emergency supply
• Repairing, restoring and reporting
• Worker distribution and pest control.

Electricity: Required electricity mainly obtained from DESCO, incase of load shedding heavy duty
generator provide electricity.
Generator:
•Name: Cummins
•Type: diesel operated.
•Capacity: 1750 kilowatt.
•Requirement: 1500 kilowatt.
Utility Service:

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
Steam:

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.
HVAC System:

HVAC System:

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%.
HEPA Filter

HEPA Filter

Water treatment plant:

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.
Effluent Treatment Plant

• 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:
• Raw materials store
• Packing material store and
• Finished product store
Warehouse Department

Conclusion:
• The pharmaceutical industry is the branch of the chemical
industry that develops, manufactures, and sells drugs.
• Defining illness is not its mission. Generally, the
medications produced by drug companies target diseases
that have been defined previously by the medical profession.
• It is also essential that these products are safe, effective, and
of good quality, and are prescribed and used rationally.

Pharmaceuticals in plant training presentation by Don

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