In-Plant Training Programme In Aristopharma Ltd. (Manufacturer Of Pharmaceutical Products)

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In-Plant Training Programme In Aristopharma Ltd. (Manufacturer Of Pharmaceutical Products)


Plant training for the professionals is now essential to know in details the application mode of modern scientific and management issues aiming to familiar them correctly.

This training is the bridge between the theories and principles with their practices, in other words between the institution and commercial organization.

For gathering complete knowledge about pharmaceutical aspect of microbiology there is no alternative for in-plant or industrial training program. This training is conducted by the pharmaceutical industries in our country. By this training, each microbiology student can achieve vast experience many of which is almost new to us; can correlate the theoretical knowledge with the practical experience. Thus we can develop ourself completely for microbiology related job in pharmaceutical company. To take part in such type of training program we have been selected THE ARISTOPHARMA LTD. This ensures manufacturing and marketing of essential medicines with highest quality by following cGMP, GLP and ISO-2000 by all modern technologies. The main dosage form manufacturing by the respective company are solid such as tablet, capsule and dry syrup. Semisolid such as ointments, creams and liquid such as suspension and syrup. Sterile products include ophthalmic, injectable product, MDI and lyophilized product. Special microbiological precautions have to maintain in sterile and liquid section. In order to GMP, every procedure and equipment has its own Standard Operating Procedure (SOP).

Policies of Aristopharma Ltd.

”Quality the Unit We Count”

To maintain and improve status of an integrated healthcare company through

v acquisition of state of arts skills and facilities and enhance competency of human resources through appropriate relevant training program.

v To adhere strictly with WHO cGMP regulations in respect to manufacturing, Quality assurance, Marketing and distribution of medicinal products and to keep compliance of regulatory specifications of local authority.

v To practice and continually improve Quality Management System (QMS) in it’s totally to consistency meet customers needs in the global context.

v To review and upgrade “Quality Audit Programme” to match with regulatory requirements.

The Journey of Aristopharma Ltd.


The journey started through the formation of a proprietorship firm under the dynamic guidance of Mr. M. A. Hassan, present Chairman & Managing Director of the company. It was a modest start with the introduction of a few products in oral liquid & tablet form.


The new manufacturing unit was commissioned at Shampur-Kadamtali with highly sophisticated and advanced facilities.


Production line was diversified with the addition of cream and ointment in the portfolio.


Company starts its international operation – Vietnam being the first country to export.


Export starts to Sri Lanka


Sterile Products Block is commissioned & Ophthalmic Products are introduced in the market.As the first Pharmaceutical Company in Bangladesh, ARISTOPHARMA exports to Hong Kong – one of the most developed markets of Asia.


The diversification rolls on – parenteral dosage form is introduced.


Company touches another landmark in international operation – export starts to Singapore.

Export of highly sophisticated Ophthalmic Products starts to Hong Kong. Export also strarts to another country – Macau.


Company crosses the continental boundary export start to Ukraine of East Europe.


Export starts to Mauritius of Africa. Became No. 1 in Ophthalmic market in Bangladesh. Enters the top 10 chart of Bangladesh Pharmaceutical Market.


Agreement is signed with APC, Australia to set up its 3rd plant at Gacha, Gazipur for Europe/American Market. Export starts to United Arab Emirates of Middle East and Nigeria of Africa.


Export starts to Pakistan. The new expansion building of factory starts operation with the facilities for inhalers, lyophilized injections, pre-filled injections, suppositories etc.


New plant is under construction in Gazipur (Gacha). Manufacturing of insulin, suppository,amino acid will be started this year.And the journey continues…


Drug substances are most frequently administered orally by means of solid dosage forms, such as tablets and capsules. Solid dosage forms are some of the least expensive, most popular and convenient methods for drug delivery. Here we would focus different aspects of tablet making procedure and the equipment involved in it.

Total Units in Solid Department

Manufacturing area Packaging area


Granulation unit Compression unit Coating unit Capsule filling unit

Contents of a tablet

1. Active Ingredients

2. Filler/Diluents

3. Disintegrant

4. Binder

5. Lubricant

6. Glidant Excipients

7. Antiadherent

8. Flavourings

9. Colourings

· Filler/Diluents – to increase the size (bulk) of the tablet. It is necessary as, sometimes, the active ingredient used is in very small quantity and thus would be too small to handle the tablet.

· Disintegrant – helps the tablet to break down into small fragments, when it is ingested. This helps the medicine to dissolve and be taken up by the body quickly for it to act swiftly.

· Binder – to hold the tablet together after it has been compressed, stopping it from breaking down into its separate ingredients.

· Lubricant – to ensure that the tablet has a smooth surface and that the powder does not stick to the equipment used to make the tablet.

· Glidant– to help to keep the powder, used to make a tablet, flowing as the tablet and stopping it from forming lumps.

· Antiadherent– to stop the powder from sticking to the equipment as the tablet is being made.

· Flavourings – to make the tablets smell and taste better.

· Colourings – to distinguish one tablet from another.

Process of tablet making




Powder compression



Secondary Packaging

q Several categories of tablets for oral use may be distinguished as:

· Uncoated tablets

· Coated tablets

· Effervescent tablets

· Soluble tablets

· Dispersible tablets

· Orodispersible tablets

· Gastro-resistant tablets

· Modified-release tablets

· Tablets for use in the mouth


Granulation is the process in which the powder particles of raw materials are made to form larger particles in order to facilitate compression for the production of tablet.

The purposes of granulation are:

– To produce tablets of appropriate size.

– To prevent segregation of the constituents in the powder mix.

– To improve the flow properties of the powder mix.

– To improve compression nature of powder.

Granulation Processes which are performed in the Aristopharma plant are following:

· Wet Granulation.

· Dry Granulation.

· Direct compression

Wet granulation

Wet granulation is a process of using a liquid binder or adhesive to the powder mixture. The amount of liquid can be properly managed, and over wetting will cause the granules to be too hard and under wetting will cause them to be too soft and friable. Aqueous solutions have the advantage of being safer to deal with than solvents.

Dry granulation

This process is used when the product needed to be granulated may be sensitive to moisture and heat. Dry granulation can be conducted on a press using slugging tooling or on a roller compactor commonly referred to as a chilsonator. Dry granulation equipment offers a wide range of pressure and roll types to attain proper densification. However, the process may require repeated compaction steps to attain the proper granule end point.

Direct compression

This method is used when a group of ingredients can be blended and placed in a tablet press to make a tablet without any of the ingredients having to be changed. This is not very common because many tablets have active pharmaceutical ingredients which will not allow for direct compression due to their concentration or the excipients used in formulation are not conducive to direct compression

Difference between Wet and Dry Granlation

Wet granulation Dry granulation
Weighing of active ingredient as well as excipients and sieving it


Dry mixing


Wet mixing (addition of wet binder)


Initial phase drying in Fluid Bed Dryer (FBD)


Milling in the Multimill


Partial drying in FBD


Milling in the Multimill


Terminal/Final drying in the FBD


Sieving in the Vibratory Sifter according to the required particle/granule size


Check moisture content and dry accordingly. Add lubricant.


Granules of desired size ready for blending.

Weighing of drugs and excipients; then sieving them.


Dry mixing of drugs and diluents


Slugging or pre-compression


Milling and sieving




Discharge for compression

Condition for manufacturing of Granules:

Relative humidity: Not more than 55%.

Temperature: Below 250C.

Mixing & Blending:

A powder blend should be as uniform as possible to assure the proper amount of medication in each dosages unit. The blending of solid particles is affected by the shape, density, size & size range of the particles, and surface effects such as absorbed liquid film, electrostatic charges & Van der Waals forces. Small particles are difficult to blend because they exhibit poor fluidity. However, more important than actual particle size is particle size range. All drugs & chemicals should be reduced to approximately the same size prior to weighing & mixing


Tablet Processing unit: 1

Name of the machines Purpose
1.Planetary mixer-60 kg,

Gansons, India.

To mix the active ingredient and binder to form granules.
2.FBD-1-10 kg, Alliance Eng. Co. India To Dry granules.
3.Multi mill-1 To reduce the size of granules.
4.Double cone Blender To mix uniformly all the excipients.
5.Tablet oscillating Granulator To reduce the size of granules.
6.Paste Kettle Preparation of slurry
Pam Glatt Fluid Bed Processor India Preparation of granules

Tablet Processing unit: 2

Name of the machines Purpose
1.RMG– 160 kg, Saral ENG. Company LTD. To mix the active ingredient and binder to form granules.
To Dry granules.
2. Y- cone and Double cone blenders. To mix the processed granules with lubricating agents.

Fig: Rapid mixing granulator (RMG) Fig: Fluid bed dryer

Fig: Multi Miller Fig: Double cone blender

Features Specifications: Rapid Mixer Granulator:

Technical Specifications

  • Standard processing duration
  • Dry mixing approx 3 – 5 minutes
  • Wet mixing approx 5 – 10 minutes
  • Wet granulation approx 5 – 10 minutes
  • Discharge approx 1-15 minutes

Unique features:

  • RMG improved processing
  • Uniform distribution of all formulation ingredients
  • Reduced mixing and granulation time
  • Useful working capacity of up to 80% to 40% of bowl volume
  • Uniform granules by gentle processing
  • Widely applicable
  • Easy scale up & scale down between machine sizes
  • Bowl shape design to have no dead spaces
  • Homogeneous binder distribution
  • Enclosed moving parts
  • Ensured safety
  • Air purge sealing for main shaft and Chopper shaft.
  • Auto / Manual controls
  • Hydraulic/ Pneumatic lifting of main shaft for cleaning

q Tablet Compression

Compression is the reduction of the bulk size of a tablet due to high pressure. In the compression of active pharmaceutical ingredients, overall control is essential to ensure high quality.

Flow chart of Compression

Granules (previously made)

Transfer of granules in the Hooper of tablet press machine

By hand or auto powder/granules loader

Rising of upper punch & dropping of lower punch


Filling of die cavity through feed frame


Removal of extra granules by scrape off plate


Coming down of upper punch for

Compression to produce tablet

Raising of both upper & lower punches

To certain extent

Ejection of tablet with the help of take out plate

Conventional Uncoated Tablets

Of desired shape and size

Tablet-machine parts:

Ø Hopper

Ø Main compression roller

Ø Feed frame

Ø Compression station

Ø Feed paddles

Ø Ejection cam

Ø Draw down cam

Ø Take off blade

Ø Weight controller fills station

Ø Ejection station

Ø Pre-compression roller

Ø Take off chute.

Machines used in the Tablet Press unit for Compression:

# B-tooling machine ? Die 30 mm & punch 19 mm (35 punches)

# D-tooling machine ? Die 38 mm & punch 25 mm (27, 35 punches)

There are 08 compression machines:

# 1 automatic machine 30 station. (Sejong)

# Press machines {Station: -16, 23(1), 27(1), 35(3), and 37(1)}

Automatic tablet compression machine:

New Se Jong Model 37 Station Rotary Tablet Press. Machine


1) Unit has the capacity to deliver 54,000 to 216,000 tablets per hour.

2) Maximum Tablet Diameter: 16mm, Maximum Tablet Thickness: 8.5 mm, Filling Depth: 4.5 to 10mm, 8.5 to 14mm, 12.5 to 18mm

(3) Lubrication System: Automatic lubrication by cycle pump, Lubricating interval and amount can be reset

(4) Feeding System: Mechanical feeder as standard, open feeder is available as an option, Stainless Steel hopper with sight port.

(5) Tooling: ‘B’ Type.

Common Problems that arise during Compression:

Common Problems that generally arise during compression are-

· Capping

· Chipping

· Sticking

· Weight variation

· Mottling

· Hardness problem

· Lamination

Tablet Coating:

Coated tablets have a smooth surface which is often colored and may be polished; a broken section, when examined under a lens, shows a core surrounded by one or more continuous layers with a different texture.

Classification of Coating:

Mainly three types of coating are performed in the solid section. They are as follows:


Sugar coating Film coating Enteric coating

Aqueous coating Organic coating

Sugar Coating

In suitable sugar- coating equipment, the tablet cores are successively treated with aqueous sucrose solutions which, depending on the stage of the coating reached, may contain other functional ingredients e.g. fillers, colors etc. The build up of coating material is due to transference of coating medium from one tablet to another.

Stages of Sugar Coating-

  1. Sealing
  2. Subcoating

Film coating

In film coating two polymers are highly used. One is HPMC and another is Eudragit-L100 and L-50 (liquid). In aqueous solution water is used as solvent but in organic solution – methanol, methylene chloride and PEG 6000 are used. The distance between spray gun and tablet bed, incase of organic solvent is 3-4 inch and incase of aqueous solvents is 8 inch. Pan rotation is within 3-15/hr. it varies from product to product. Air pressure is maintained to 1.5-4 kg.

Steam temperature:

Coating Inlet Outlet
Organic 750c 650c
Aqueous 60/650c 50/550c

? 200 kg coating machine containing spray guns.

? 110 kg coating machine containing spray guns

? 100,70, 20 kg coating machine containing spray guns

Enteric coating

There are two steps for enteric coating

? Sub-coating: Sub coating is performed by using HPMC as polymer with either organic or aqueous solution. This process performs for 5 hours.

? Enteric coating: Enteric coating is performed by using eudragit L-100 or L-50 over the sub coating. This is done for 15 hours.

Name of the Machine CAPACITY

q Condition required during Coating:

Ø Relative Humidity: Not more than 50%.

Ø Temperature: Below 250C.

Common problem associated with tablet coating:

1. Logo bridging


– Surface characteristics of the product being coated

– Inadequate adhesion of film coating

– Inadequate design of logo (e.g. too detail/fine logo)


– Modify core formulation to include more hydrophilic ingredients

– Increase core porosity

– Using formulation with increased adhesion property.

– Increase area within the debossing and modified angles.

2. Core erosion


– Inherent softness or high friability of core.

– Excessive pan speed in coating process.

– Spray rate too low.

– High sensitivity of core to moisture as coating is applied.


– Increase mechanical strength of core.

– Decrease pan speed.

– Increase spray rate.

3. Edge chipping/erosion


– Low mechanical strength of coating

– Excessive pan speed

– Low solid content in coating liquid

– Low spray rate

– Sharp edges on tablets

– Worn tablet punches


– Using formulation with increased mechanical strength

– Decreased pan speed

– Increase solid content in coating liquid

– Decrease spray rate

– Use modified punch design

4. Picking/sticking:


– Spray rate too high

– Inadequate drying condition

– Pan speed too low

– Inadequate atomization of coating liquid

– Poor distribution of coating liquid


– Decrease spray rate

– Increase drying condition

– Increase pan speed

– Increase atomizing air pressure/volume

– Increase number of spray gun

5. Cracking


– Low mechanical strength of coating, exacerbated by inadequate plasticization, excessive pigmentation.

– Core has significantly different thermal expansion characteristics than coating.

– Extended strain relaxation of core after compaction.


– Selecting formulation with increased mechanical strength and elasticity properties.

– Avoid use of mineral type fillers (e.g. CaCO3, CaSO4, MgCO3 etc.)

– Extend holding period of tablets prior to submitting them to coating process.

6. Peeling


– Low mechanical strength of coating

– Poor adhesion of coating to tablet surface


– Using ingredients of improved mechanical strength.

– Using ingredients with improved adhesion properties.

7. Orange peel/roughness


– Viscosity of coating liquid is too high

– Poor atomization of coating liquid

– Excessive drying condition

– Over wetting (causing coating too rub)


– Decrease solid content of coating liquid

– Increase atomizing air pressure/volume

– Decrease inlet air temperature/flow rate

8. Twinning


– Spray rate too high

– Pan speed too low

– Inappropriate tablet shape


– Decrease spray rate

– Increase atomizing efficiency

– Increase pan speed

– Select new tablet shape that decrease chances of flat surfaces coming into contact during application of coating liquid. (e.g. avoid capsule shape tablet with thick side wall)


Capsules are solid dosage forms in which the drug substance is enclosed in either a hard or soft soluble shell of a suitable form of gelatin, usually containing a single dose of active substance(s). They are intended for oral administration.

The capsule shells are made of gelatin or other substances, the consistency of which may be adjusted by the addition of substances such as glycerol or sorbitol. Excipients such as surface-active agents, opaque fillers, antimicrobial preservatives, sweeteners, coloring matter and flavoring substances may be added

In this pharmaceutical industry encapsulation, sealing and polishing of capsules of hard gelatin shell are done during manufacturing, as the industry does not manufacture any capsule shell and has to be brought separately. The active is filled in the empty the hard gelatin capsule shell in the form of powder and pellets.

There are 6 different sizes of empty hard gelatin capsule shells used in AristopharmaLtd. for general production, which include

§ Capsule shell size 0

§ Capsule shell size 00

§ Capsule shell size 1

§ Capsule shell size 2

§ Capsule shell size 3

§ Capsule shell size 4

Encapsulation Process by Automatic Capsule Filling Machine:

Blend Pellets with NPS




For encapsulation of powder,










Encapsulation Process by Manual Capsule Filling Machine by Hand:

Loading of capsule in the loading plate


Removal of caps of the shells


Filling of powder


Rejoining of caps of the shells




Sorting of Capsules


Polishing of Capsul


Machine name Machine specification Manufacturer Origin
Semi automatic Capsule filling machine Capacity: 15000-17000/hr Capsule fill P+am pharmaceuticals India
Automatic Capsule filling machine Capacity: 30000/hr Capsule fill Hanli Korea
Automatic Capsule filling machine Capacity:90000/hr

Capsule fill

Se jong Korea
S.S.Drum -Blender Capacity: 200 kg Gansons India.
Charge Vat Capacity: 50 kg Myth Bangladesh
Cap. polishing machine P+am pharmaceuticals India
Hand fill machine Capacity:8000/hr Pharmachem India


Dry syrup, in Aristopharma, is manufactured by dry mixing method.

Dry mixing procedure flow chart

Crushing the sucrose in FITZ mill at 3000 rpm


Transfer of half portion of sucrose from step-1 into

a double cone blender by passing through a 20 mesh screen


Transfer of all other excipients in the blender

to blend for 30 minute


Transfer the mix from the double cone blender by

Passing through a 20 mash screen

Condition for manufacturing Dry Syrup

Relative Humidity: Not more than 45%.

Temperature: Below 250

q Machines used in the Dry Syrup Manufacturing unit:

Name of the Machine Function
Double cone Blender Blending/Mixing
FITZ Mill Crushing/ Milling
Dust Collector Removal of dust
Bottle Filling Machine Filling of Dry Syrup
Bottle Sealing Machine Sealing of Dry Syrup Bottle

q Packaging

Packaging can be described as a coordinated system of providing, presentation, protection, identification/information, containment, convenience, and compliance for a product during storage, carriage, display and use until such time as the product is used or administered.

Purpose of packaging

Ø To increase the acceptability of the drug

Ø Physical protection and barrier protection to increase the stability of the drug

Ø To minimize the transport/shipping hazards

Ø To improve patients’ compliance

Ø Containment or agglomeration. Liquids, powders, and granular materials need containment.

Ø Information transmission and marketing

Ø To improve the pharmaceutical elegance by the use of special color or contrasting printing

At Aristopharma, two types of blister, PVC- Aluminium Blister and Aluminium Blistercombination are used.

Packaging can be divided into two categories mainly; primary packaging and secondary packaging.

Primary packaging is the material that first envelops the product and holds it.

Secondary packaging is outside the primary packaging, perhaps used to group primary packages together.

There is also tertiary packaging which is used for bulk handling, warehouse storage and transport shipping.

Primary Packaging Materials

Materials Thickness
  1. Polyvinyl Chloride [PVC], (PVC/PVC)
  2. Polyvinylidine chloride [PVDC]
  3. Aluminium Foil
250-300 ?m

250 ?m

20 ?m (top)

130 ?m (Bottom)

Packaging Machineries:

Machine Name Machine specification No. of Machine Manufactured by Origin
Automatic Blister Pack machine Capacity:


1 Buchon Korea
Automatic Blister Pack machine Capacity:


1 Buchon Korea
Automatic Blister Pack machine Capacity:


1 Buchon Korea
Automatic Blister Pack machine Capacity:


1 Hoong-A Korea
Automatic Blister Pack machine Capacity:


1 Hoong-A Korea
Automatic Blister Pack machine Capacity:


2 Elmapack India.
Strip Packing machine Capacity:


1 Gansons India.

Major Steps of blister packaging:

PVC sheet

Heating plate

Foil softens by hot plate at temp. 125-145°C

Passed through desired dies plate which is keptcold& air pressure is applied to make pocket for small time & desired shape is resulted (air pressure 6-8 bar)

Tablets or capsules are filled into the pockets

Pressed by two plates simultaneously (upper plate temp. 160-180°C for PVC & lower plate is cold)

Passed through cutter

Desired blister pack

Major steps of strip packaging:

Tablets or capsules in hopper

Tablets/capsules in vibrating disc

Enter through tode channel

Tablets or capsules enter between two alu roll strips

Hot roller having particular dies shape


Poly-coated alu rolls (coated with plastic materials) come from two sides

Strip packaging

Trouble shooting

Ø Preheating problem – malleability

Ø Forming problem

Ø Sealing problem

Ø Slitting problem – perforation

Ø Loading problem

Ø Air pressure

Ø Scanner problem

Ø Emboss problem

Ø Heat exchanger

Ø Feeding problem –

o Chute channel

o Gate transfer

o Spiral

o Brush

In-process check:

Ø Observation no.

Ø Leakage test (at 400 mm Hg )

Ø Room condition

o Temperature & humidity

o Segregation of bulk materials/finished packs

o Product identity

o Line, display board

Ø Aluminum foil leaving in machine and stock

Ø Number of individual strips/blisters checked

Ø Number of finished products checked

Ø Quality and identity of components compliant slip/labels/cartons/leaflets/outer labels/outer box/ spoon

Ø Identity and appearance of product in packs

Ø Quantity: No./volume/weight

Ø Overprinting/embossing: batch no./MFD/Exp date/MRP

Ø Label/carton with product name, Batch no, Mfg date, price, and Exp date.


The liquid department in Aristopharma Ltd. is divided into four sections. They are:

Ø Liquid

Ø Cream,ointment& gel

Ø Topical

Ø suppository

General working procedure of liquid

Receive monthly product schedule


Analysis the monthly product schedule


BMR &BPR prepared


QA approval


Sent BMR, BPR to RM &PM


Receive the materials








Transferring to finished goods

Procedure of a liquid formation

Active ingradient


Suspending agent (guargum)


Solvent (purified water)


Sweeting agent (aspartame,saccharineetc)


Buffering agent (citric acid, sodium citrate etc )


Preservatives (sodium benzoate, methyl paraphene)


Co-solvent (propylene glycol)


Coloring agent


Flavouring agent


Viscosity enhancer (glycerine)

Suspension preparation Steps

Dispersion of suspending agent


Transfer to compounding vessel containing sucrose solution


Addition of drugs & other ingredient


Mixing with continuous stirring


Adjustment of final volume with purified water


Filling & sealing



Condition For Manufacturing Of Oral Liquids:

Relative Humidity: Not more than 55%.

Temperature: Below 30oc

q Machines used in the Oral Liquid Manufacturing unit:

Name of the Machine Function Capacity
Steam Jacketed Vessel Mixing 1000 Liter
Charge Vessel Manufacturing 2000 Liter
Storage Vessel Storage 2000 Liter
Cartridge Filter Filtration
Bottle Filling & Sealing Machine Filling &Sealing of Oral Liquid Bottles 2500 bottles /hour

q Condition for manufacturing of Oral Liquids:

Ø Relative Humidity: Not more than 55%.

Ø Temperature: Below 30oc

Cream, Ointment & Gel

Cream, ointment and gel fall into topical product. Semi sterile condition is maintained here.

Cream is made of two ways; firstly water in oil; secondly, oil in water.

In ointment, no water is used, only oil.

In gel, both water and oil is used.

General process for manufacturing of cream

Water Phase
Water phase to Oil phase in a steam jacketed vessel
Blending by mechanical stirrer
Oil Phase

General process for manufacturing ointments


Machine Name Specification and Origin
Vacuum Emulsifying Mixer China
Auto tube filling and sealing machine China
Automatic tube filling machine Precitechindustries,india
Automatic tube filling machine Pharmachemmachinaries,india
Colloid mill Cadmach ,India
Charging vessel Mythindustries,Bangladesh
High speed emulsifier India
Vacuum homogeniger China
Transfer pump U.S.A
Automatic labeling machine Korea
Automatic liquid filling, Cap Sealing and labeling machine India
Machine Name Specification and Origin
Vacuum Emulsifying Mixer China
Auto tube filling and sealing machine China
Automatic tube filling machine Precitechindustries,india
Automatic tube filling machine Pharmachemmachinaries,india
Colloid mill Cadmach ,India
Charging vessel Mythindustries,Bangladesh
High speed emulsifier India
Vacuum homogeniger China
Transfer pump U.S.A
Automatic labeling machine Korea
Automatic liquid filling, Cap Sealing and labeling machine India


A suppository is a drug delivery system that is inserted intotherectum (rectal suppository), vagina (vaginal suppository) or urethra (urethral suppository), where it dissolves.

They are used to deliver both systemically-acting and locally-acting medications. The general principle is that the suppository is inserted as a solid, and will dissolve inside the body to deliver the medicine pseudo received by the many blood vessels that follow the larger intestine.


Temperature– 45-50oC

Base– Carnauba Wax


Aristopharma is a leading pharmaceutical company in Bangladesh and leading to produce ophthalmic product in Bangladesh. Aristopharma is now manufacturing different types of sterile dosages form including ophthalmic eye drop, eye ointment, eye cream, nasal drop, ear drop as well as IV and IM injection and recently included lyophilized product. Recently they have launched their MDI and Insulin product. They have a future plan for manufacturing of amino acid product,hormone& anti cancer product.

Doses forms in Sterile Department

§ Liquid injection (suspension)

§ Eye drop

§ Eye ointment

§ Dry vial

§ Lyophilized vial

§ Pre-filled syringe

§ Lyophilized injection

§ Insulin

Generally the products are manufactured by two ways:

Aseptically Sterilized

Terminally Sterilized

Injectable Products in Ampoule

Injectable products are dispensed in ampoules in the following procedure:

Ampoule De-boxing


Ampoule washing


Sterilization (in case of aseptically filled ampoules)


Ampoule filling (under laminar air flow)


Ampoule Sealing


Terminal Sterilization


Ampoule Inspection


Sealed Ampoules

Ampoule washing sequence

DM water (inner-outer) ? Compressed air spray ? Distilled water ? WFI

Ampoule Filling & Sealing (under laminar air flow)

Ampoule on the filling belt®N2 flush ®Filling ® N2 flush ® Sealing by flame ® Ejection

Ampoule Inspection

– The white zone detects visually the black particles,

– The black zone detects the white particles.

– The volume is measured visually by taking 4 ampoules at a time in hand

Different Sterilization Techniques & their uses

Sterilization Technique Temperature

( 0C)

Exposure Time




Dry Heat Sterilization (DHS) 180 3 1.1 Vials
220 2.5 1.1
250 1 1.1
Steam Sterilization /Autoclave 121 0.5 1.1 Ampoules, Gloves, Filters, Gourmets

Manufacturing of injectable preparations require a clean room which should have the following standard:

Class Cfu/m3 Particle of 0.5 micron/ft3 Particle of 5 micron /ft3
100 <1 NMT 100 0
1000 NMT 10 NMT 1000 NMT 7
10,000 NMT 100 NMT 10,000 NMT 70
1,00,000 NMT 1,00,000 NMT 700

Category of different vial processing area

Area Clean room standard
Filling point 100
Filling room 1,000
Vial washing & sterilization room 10,000
Filling room corridor 10,000
Fabrics change room 10,000

Category of different ampoule processing area

Area Clean room standard
Filling point 100
Filling room 1,000
Mixing room 10,000
Filling room corridor 10,000
Fabrics change room 10,000

Injectable products (powder or solution) in Via