In Plant Training Program in
Navana Pharmaceuticals Limited
QUALITY POLICY OF
NAVANA PHARMACEUTICAL LTD.
Navana’s mission is to achieve business excellence through product quality and committed to ensure customer satisfaction by exceeding their level of expectations.
It is the policy of Navana to ensure all products manufactured in the factory pass through appropriate product development activities and to monitor product quality throughout its shelf life.
Navana is committed to comply with the WHO cGMP standards and will follow local drug regulatory norms in every phases of product development, manufacturing quality assurance and distribution of medicines.
Ensure all activities through documented quality management system (QMS) complying International standard requirements of ISO 9001:2000 through continuous developing of Human resources.
Navana will continually improve the effectiveness of quality Management System and will undertake appropriate review, evaluation and performance measurement of its operations to ensure complains Quality policy.
Purposes of in-plant training:
Pharmacy is the art and science of preparing & dispensing medications and the provision of drug & related information to the public. A pharmacist is a specialist in medications, a custodian of medical information, a companion of physician, a counselor to the patient, and above all, a guardian of the public health. Thus pharmacists, have a very important role- in the national health care system. They are rendering valuable services to the people- by making quality medicines.
In order to build up more efficient pharmacist in all aspects of this noble profession the students studying in B.Pharm (Honors) course are designed by their respective authorities to acquire practical knowledge from the renowned pharmaceutical industries because they could not have opportunities of occupying themselves with applied phenomenon on the medicinal products beyond their theoretical lessons as well as industrial operations.
With this view i.e. to make the students efficient and professionally skilled pharmacists, the Department of Pharmacy, University of Science and Technology, Chittagong (USTC) sent us to the NAVANA Pharmaceuticals Ltd. for our training. It was our great pleasure to join this In-Plant Training iin NAVANA Pharmaceuticals Ltd. which is one of the most well organized Drug manufacturing companies in Bangladesh. There we completed the In-Plant Training from 6th November, 2010 to 7th December, 2010. During this training, we were exposed to different production sites, Quality Assurance and Quality control department, Product development. We also gathered knowledge about Administration, Inventory control and planning, Marketing and Warehouse. We would try our best to summarize our gathered achievement at In-Plant Training on this report. The certificate given by the company after completing the training is to be submitted to the pharmacy council or pharmacy registration examination. Without this certificate no student will be allowed to appear in this exam.
Purpose of this report:
The report which is submitted after the training program is a reflection what the trainee have learnt. It also improves the writing and presenting skills. It also says the limitation and perfection of the company, so the report is important both for the trainee and the plant.
We, the three students of 15th batch of Pharmacy Department of University of Science and Technology, Chittagong (USTC) have successfully completed the one month training in Navana Pharmaceuticals Ltd. We took the notes during our visit to different departments. So, this report will only represent what we have seen, what we have learnt and what we have been taught.
We hope this report will help us to implement our experiences in our working field. We will feel worthy, if this report helps other pharmacy students to learn about Navana Pharmaceuticals Ltd.
Quality of drugs:
Generally we take drug to prevent, moreover to treat a disease. If the drug is therapeutically active and has the capability to show its credit for the desired reason then we can call the drug as a quality drug. We should remember that the elegancies as well as appearance can increase the drugs acceptability.
According to ISO 8402 quality is defined as” Total of features and characteristics of a product or service that bears on its ability to satisfy a given need’’.
Aspects of the quality of a drug:
Drug is one of the prime tools for saving lives. A medicinal product must satisfy certain standards to claim it to be a quality drug. The main criteria for quality of any drug in dosage form are it’s-
· Safety · Potency
· Efficacy · Stability
· Acceptability · Regulatory compliance
Quality Assurance is the sum total of the organized arrangements made with the object of ensuring that the product will be of the quality require by their intended use. It is good manufacturing practice plus factors outside the scope of these guidelines. The chain of quality assurance activity stretches from the product development stage up to the end users. Quality Assurance is a wide ranging concept which covers all matters which individually or collectively influence the quality of a product. It is the sum total of the organized arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practice plus other factors outside the scope of this Guide.
QA = Product design + GMP + QC + Quality goal activities
Objectives of quality assurance:
1. Raw material specifications
2. Packaging material specifications
3. Intermediate product specifications
4. Bulk product specifications
5. Finished product specifications
Quality control is a part of quality assurance. Quality control refers to the process of striving to produce a perfect product by a series of measures requiring an organized effort by the entire company to prevent or eliminate errors at every stage in production. It concerns quality control of raw materials, finished products and packaging materials.
Quality control is a comprehensive course which will help all students quickly and easily identify and correct error in quality control procedure.
QC = Test +Assessment
Raw materials specification depends upon the following parameters:
• Appearance · Odor
• Solubility · Water Content
• PH · Residue on ignition
• Heavy metals · Absorptivity
• Assay (HPLC/IR/UV) · Loss on drying
• Viscosity · Melting point
• Turbidity · Bulk density
• Sterility/Pyrogen · Screen test
• Specific gravity · Specific volume
In process control:
The In-process control is the checks made during the course of manufacturing process which aims to ensure that product will comply with specifications. Thus quality is built into the product. Although these checks are not a part of final product specifications but done as a part of control evidence that the correct operations did apply during manufacture.
Advantages of IPC:
· Allows timely action
· Improves productivity
· Reduces rejection cost
· Reduces the chance of batch failure
Some commonly performed IPC checks:
|1.Dispensing||Weighing and recording.|
|2.Mixing||Time and speed, Temperature.|
|3.Granulation||Time and speed, Homogeneity of the content.|
|4.Drying||Temperature (Inlet and outlet air), Time, Pressure, LOD (Loss on drying).|
|5.Tableting||Machine speed, Compression pressure, Thickness, Hardness, Appearance, Friability, Disintegration time, Dissolution test.|
|6.Coating||Temperature, speed, Uniformity, Spray rate, Degree of atomization and Weight.|
|7.Oral liquid||Temperature curve of heating jacket.|
In process quality control depends on the following parameters:
A) For Tablet:
• Blend uniformity · Loss on drying
• Appearance · Average weight
• Dosage uniformity · Hardness
• Thickness · Friability
• Weight variation · Disintegration
B) For Liquids:
• Appearance · pH
• Specific gravity · Viscosity
• Re-suspendability · Flavor
· Preservative · Average fill intent
Quality control after granulation:
Only moisture content will be detected after granulation.
Quality control after mixing:
• Moisture content.
• Blend assay (for those drug, which has very small quantity of drug content)
Quality control after compression:
• Length · Width
• Thickness · Hardness
• Friability · Disintegration time
Quality control for coating approval:
· Hardness · Friability
• Moisture content · Disintegration time
• Average weight of tablet · Drug content
In process quality control for Blistering:
• sealing temperature · Pre heat temperature
• Air press in bar · Room temp.
• Humidity · Batch coding
• Visible defects · Foil Alignment
• Leak test.
In process quality control for Packaging Materials:
• Faulty container or closure
• Mislabeled product
• Printing errors
Finished product testing should be performed by the quality unit & should conform to written specification.
Finished product specification depends on the following parameters:
· -Dosage uniformity · Loss on drying (LOD)
· Hardness of tablets · Thickness of tablets
· -Disintegration · Dissolution
· -Average weight
· Temperature ‹Inlet and outlet air› · Speed and time
· Uniformity and weight · Appearance
· Disintegration time Dissolution test
· Appearance · PH
· Specific Gravity · Foreign matter
· Assay · Viscosity
· Fill variation · Volume in container
· Moisture Content
· Average weight
For Dry syrup:
· PH ?Viscosity
· Moisture Content Potency
· Weight variation
Documentation is a prime necessity in quality assurance. Its purpose is to define the system control, to reduce the risk of error, so that personnel are instructed in details of and follow the procedures concerned and to permit investigation and tracing of defective products.
To facilitate proper and effective use of documents they should be designed and prepared with care.
1. The title, nature and purpose of the document is to be clearly stated.
2. The way the document is to be used, and by whom, should be clearly apparent from the document itself.
3. Where documents bear instruction they should be written in the imperative. They should be clear, precise and in language the user can understand.
4. Documents, which require the entry of data, should provide sufficient space for the entry.
5. Reproduced documents should be clear and legible.
Flow chart for Quality Assurance activity:
Receiving of Raw & packaging Attachment of quarantine
Materials by visual inspection Tag of yellow color
Sampling of raw & packaging
Materials for QC analysis
Release / rejection Attachment of respective
tag for raw & packaging
Dispensing of raw & packaging
Checking of cleanliness,
Approval of equipment
& area of manufacturing
In process checking of Sampling of in process
Some parameters during Product to Q.C.
Compression, filling etc.
In process checking of
Transfer of finished product
For distribution after
Collecting the retention sample
Investigation of product complaints,
product recall returned product from
Equipment in Quality Assurance:
|Name||Source||Scope||Calibration Time Interval||Calibration Factor|
|Digital Polarimeter||England||Determination of Specific Optical Rotation||6 month||Quartz control cell|
|Karl Fischer||Bound moister determination||1 month||Electrode sensitivity|
|High Pressures Liquid Chromatography (HPLC)||Poland||Qualitative and Quantitative analysis||6 month||Retention time, Peak area.|
|Fourier Transform Infra-Red Spectrophotometer (FTIR-8101A)||Japan||Sample identification||3 month||Shape of power spectrum , Wavelength (accuracy, resolution, reproducibility)|
|UV-Spectrophotometer (UV-1601pc)||Japan||Identification and Potency determination||3 month||Control of absorbance (235, 257, 313 and 350 nm.),Cell (Holmium and Didymium cells )|
|Disintegration Tester||India||Disintegration time||6 month||Temperature and cycle.|
|Dissolution Tester 8 stage basket system‹TDT-08L›||India||Dissolution||6 month||Temperature and rpm|
|Tablet Friability Test apparatus USP||India||Friability||6 month||rpm|
|Digital Tablet Hardness Tester‹TSF-1000›||England||Determination of Tablet
|Analytical balance||Switzerland||Weight||3 month||Wight (BSTI approval).|
|Melting point Apparatus||England||Identification||1 year||Vanillin, Phenacetin and Caffeine|
|Slide Caliper||Poland||Size, Diameter,
|Centrifuge Machine‹ S-549›||UK||Analytical Work in QA||rpm|
|Opti-melt ‹Automated melting point system›||England||Determination of Melting
|1 year||Vanillin, Phenacetin and Caffeine|
|Laminar Air flow cabinet (HEPA)||To avoid cross contamination|
|Sartorius PH meter||Germany||PH||daily||PH (4,7,11)|
|Moister Analyser||USA||LOD||3 month||Wight|
|Digital Automatic Tap density test Apparatus(350T)||Germany||Determination of Density|
|Micrometer(PAT No.200959)||Japan||Thickness of package|
Figure: UV machine (Double beam spectrophotometry)
Figure; F510 FT-IR Spectrophotometry
Some of the reagents:
?Karl-Fischer reagent, ? Bromocresol green,
?Crystal violet, ?a-Naphthol benzene,
? Methanol, ?Methyl orange/ red,
?Starch, ?Na-acetale buffer,
?Potassium iodide, ? Acetic acid.
?Iodine solution, ?Acetonitrile,
? 2- Butanol, ?Citric acid,
?Cyclohexane, ? Hexane,
?Ether, ?Dithiozone etc.
All reagents are of pharmaceutical standard sources.
Some of the glass wares:
?Conical flask, ? Burette,
?Pipette, ?Volumetric flask,
?Beaker, ?Graduated cylinder,
?Separating funnel. ?Glass bottles,
? Round bottom flask, ? Desicator etc.
All instruments are of pharmaceutical standard.
Solid dosage forms are some of the least expensive, most popular and convenient methods for drug delivery. They can be produced in a non-sterile environment and the technology is well-known after more than 100 years of development. Since most pharmaceuticals are produced in solid dosage forms, it is important that the unit operations for their production be thoroughly understood. This course focuses on the fundamentals of each discrete processing step (unit operation) required for the manufacture and packaging of tablets and capsules, the most common of solid dosage forms.
Total Units in Production Area
Manufacturing area Packaging area
Liquid manufacturing Solid manufacturing
Granulation unit Compression unit Coating unit Capsule filling unit
1. Introduction of Tablet
Tablets may be defined as a solid unit dosages form of medicament or medicaments with or without suitable diluents and prepared either by molding or by compression. They vary greatly in shape, size and weight which depend upon the amount of medicament and mode of administration.
Compressed tablets usually consist of active medicaments mixed with a number of inert substances known as excipients. These additives are added to given the qualities of good tablet. Although these additives are termed as inert but they have a great influence on stability, bioavailability and the process by which the dosage forms are prepared. According to the functions, which these additives play in the preparation of tablets, they are follows:
2.Binders 6.Colouring agent
3.Granulation agent 7.Flavouring agent
4.Disintegrating agent 8.Sweetening agent
When the quantity of the drug for an individual dose is very small and it is not practicable to compress such small amount in the form of a tablet then the inert substances which are to increase the bulk of powder to be easily compressed are known as diluent. For example-lactose, sucrose, mannitol, dextrose, calcium sulfate dehydrate, starch, microcrystalline cellulose (Avicel PH101,RC 591), sorbitol.
Agents that are used to convert granules from crystalline form before compression to impart cohesiveness to the powdered substance are known as binders. e.g: Polyvinyl pyrrolidone (povidone K-90),Crosspovidone,Starch-1500 partially pregalatinize maize starch.
They help the tablet to break down into small fragments, when it is ingested to dissolve and be taken up by the body so that it can act more quickly. For example-Sodium starch glycolate (Primojel), veegum, bentonite, agar, CMC, MC, Na-alginate, citrus pulp, microcrystalline cellulose (Avicel), maize starch(dry).
The glidant helps to make the powder free flowing stopping it from forming lumps.e.g: Talc, corn starch, aerosil, colloidal silica etc.
Lubricants ensure that the tablet has a smooth surface and that the powder does not stick to the equipment used to make the tablet. eg : stearic acid, Mg-stearate.
These are used for tablets need to be dissolved in buccal cavity.eg: Sucrose, lactose, mannitol, saccharin, aspartame, Acesulfame potassium ,Sorbitol solution 70% etc.
Flavouring agents help to make the tablet taste better. Example: Cherry cream, Lemon, Orange, Pineapple, Raspberry, vanillia etc.
|Colours are added to help you to recognize your tablet and to make it easier to take your medicine correctly.e.g: Color iron oxide (red,yellow), Color lake brilliant(blue), Color lake orange (yellow), Color lake quinoline (yellow), color raspberry (red), Color red 2G, Color lake erythrocine(red) etc.|
Tablets are usually right, circular solid cylinders, the end surfaces of which are flat or convex and the edges of which may be beveled. They may have break-marks and may bear a symbol or other markings. Tablets may be coated.
2. Production of tablet:
In tablet production there are several steps involved which are following:
- Dispensing and Granulation.
- Powder compression
- Blistering / Striping /Filling.
- Secondary Packaging.
Granulation may be defined as a size enlargement process which converts small particles into physically stronger and larger agglomerates in order to facilitate the flow and compression for the production of tablet. All the materials are received from the dispensing unit and granulation is performed. For suitable granulation, it is required to have 30-40% powder and 60-70% granules and also 1-5% moisture in compressing particles.
Purposes of granulation:
-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.
Types of granules:
Two types of granules are produced in the four-granulation units of the industry, which include;
· Granules with active ingredient/s
· Placebo granules without any active ingredient/s for moisture sensitive active/s or drug/s
Granulation Processes which are performed in the NAVANA plant are following:
· Wet Granulation.
· Dry Granulation.
· Direct compression
Wet granulation is a process of using a liquid binder or adhesive to the powder mixture to produce the granules. 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.
|Weighing of active ingredient as well as excipients
Wet mixing (in case of wet granulation) by addition of de-mineralized (DM) water or Maize starch paste in Rapid Mixer Granulator (RMG) for a certain time period specified in the Batch Production Record (BPR)
Initial Phase drying in Fluid Bed Dryer (FBD)
Milling in the Multi mill
Partial drying in FBD
Milling in the Multi mill
Terminal/Final drying in the FBD
Sieving in the Vibratory Sifter according to the required particle/granule size
Measurement of Loss on Drying (LOD)
Granules of desired size ready for blending.
This process is used when the materials needed to be granulated are 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.
|Weighing of drugs and excipients
Dry mixing of drugs and diluents
Slugging or pre-compression
Milling and sieving
Discharge for 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.
Mixing & Blending:
Mixing/blending may be defined as a process where two or more components or substances are treated so as to lie as nearly as possible in contact with particle of each of the other components or substances with uniform distribution of each component. A powder blend should be as uniform as possible to assure the proper amount of medication in each dosages unit. Small particles are difficult to blend because they exhibit poor fluidity. However, more important than actual particle size is particle size range.
EQUMPMENT IN PRODUCTION UNITS:
Name Source Capacity
High speed mixer Thailand 120Kg/300L
Granulator (MG -300)
Mechanical Shifter-30”M India
Multi mill-SMT India
GFG High Efficiency Fluid Bed Dryer China 120Kg
Oil Jacked Vessel for Bangladesh 40L
Double Cone blender (DCB-120) India 150Kg
Double Rotary Tab Compression India 65000/hr
Machine (Clit-27 station)
Double Rotary Tab Compression India 52000/hr
Machine (Adept-25 station)
Excella-2000(20 Station) India 33000/hr
Thai-coater 32” Thailand 50Kg
NR-Cotar-39”‹FC-39› Thailand 80Kg
|Features||Excella-2000(20 Station)||Double Rotary Tab Compression Machine (Adept-25 station||Double Rotary Tab Compression Machine (Clit-27 station)|
|Based on pressure||Dtooling||Dtooling||Btooling|
|No. of station||20||25||27|
|Rapid mixing granulator(RMG)||Fluid bed dryer|
|Fig: Double cone blender|
Compression of powders or granules means a reduction or bulk volume of a material as a result of displacement of the gaseous phase. Compression may also be defined a s the process of applying external mechanical forces to the material or the process of pressing materials to make it more firm and rigid solid. Compression is used for the manufacturing of tablet.
In the compression of active pharmaceutical ingredients, overall control is essential to ensure high quality.
Physics of tablet compression:
· ?Transitional packing
· ?Deformation of solid body
Fig: Tablet compression cycle.
Common Problems that arise during Compression:
Common Problems that generally arise during compression are-
? binding to the dies and punches
· Capping and splitting
· Lamination and Chipping
· Picking and Sticking
· Weight variation
· Hardness variation
· Double impression
· Pitted surface
· Drug instability
Coating is the process of compressing a granulating layer around the preformed or pre-compressed tablet that is the core tablet. It is an additional step for manufacturing of tablet. The substances used as coating substances are usually applied as a solution or suspension in conditions in which evaporation of the vehicle occurs leaving a polymeric layer.
Classification of Coating:
Mainly three types of coating are performed in the solid section. They are as follows:
Sugar coating Film coating Enteric coating
1 Aqueous coating
2 Non aqueous coating
1. Film coating:
Film coating is the process which involves the deposition of polymeric substances as continuous and non-porous membrane over the surface of the core tablet. In film coating the thickness of the coat is 30-100µ.
Film coating process is based on two distinct phenomena-
- Formation of film over the surface of the core tablet known as cohesion,
- Bonding between polymeric film and the surface of the core tablet known as adhesion.
Polymers used in film coating:
Hydroxy propyl methyl cellulose, methyl hydroxy ethyl cellulose, ethyl cellulose, hydroxy propyl cellulose,Na-CMC, Poly ethylene glycol, acrylate polymer.
3. Enteric coating:
It is a coating technique applied to tablets to protect the tablet core from disintegration in acid environment of the stomach to protect the acid labile drug and to avoid gastric discomfort or to delay disintegration until they reach the upper intestine.
There are two steps for enteric coating
?.Sub-coating: By using HPMC as polymer with either organic or aqueous solution. This process performs for 5 hours.
??.Enteric coating: By using udragil L-100 or L-50 over the sub coating. This is done for 15 hours.
Polymers used in enteric coating:
Hydroxy propyl methyl cellulose phthalate, poly vinyl acetate phthalate, cellulose acetate phthalate, methacrylic acid‹Udragil›-L-100, S-100,L-300.
Condition required during Coating:
· Relative Humidity: Not more than 50%.
· Temperature: Below 250C.
Common problems associated with tablet coating:
- Logo bridging
2. Core erosion
3. Edge chipping/erosion
5. Cracking: 6. Peeling
7. Orange peel/roughness
9. Tablet-to-tablet color variation
Number of tablet being produced in Navana Pharmaceuticals ltd.
· 2. Capsule
The word “capsule” is derived from the Latin word “capsula” meaning small box. Dosages forms in which unit doses of powder, semisolid or liquid drugs are enclosed within either a hard or a soft envelope or a shell are called capsules. Usually the shells are composed of gelatin.
Several categories of capsules may be distinguished:
- hard capsules;
- soft capsules;
- gastro-resistant capsules;
- modified-release capsules;
Steps involves in capsule manufacturing:
?Developing and preparing the formulation and selecting the capsule size
?Filling capsule shells (encapsulation),
?Polishing the filled capsule (if required)
(The industry does not manufacture any capsule shell.
The active is filled in the empty the hard gelatin capsule shell in the form of-
The different sizes of hard gelatin capsule shells used in pharmaceutical manufacturing are- –
SHELL SIZE FILL VOLUME‹in ml›
The capsule sizes used in Navana Pharmaceuricals Ltd. for general production-
Size-0, 1, 2, 4.
# Encapsulation Process by Automatic Capsule Filling Machine:
For encapsulation of pellets the following procedure is done with the help of Automatic Capsule Filling Machinein the capsule filling units of Navana Pharmaceuricals Ltd.
Blend Pellets with NPS
For encapsulation of powder,
Encapsulation Process by Manual Capsule Filling Machine by Hand:
For encapsulation of powder the following procedure is done with the help of Manual Capsule Filling Machineby hand in the capsule filling units of the industry:
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 Capsule
Machineries used in capsule manufacturing:
|Machine name||Machine specification||No of station/hole||Model||Manufacturer|
|Semi automatic Capsule filling machine (Scorpio)||Capacity: 18000/hr Capsule fill||600||
|P+am pharmaceuticals, India.|
|Automatic Cap-filling machine||Capacity: 40000/hr Capsule fill||48||AF-40T||P+am pharmaceuticals, India.|
|Hand filling capsule machine||Capacity: 12000/hr||300||MF-30||P+am pharmaceuticals, India|
|Double cone Blender(DCB150)||Capacity: 150Kg(rpm:25)||India|
|Capsule polishing machine||Hoong-a corporation,korea.|
Number of Capsule being produced in Navana Pharmaceuticals Ltd.
|Trade name||Generic Name|
Manufactured method in Navana Pharmaceuticals Ltd,
Ø Direct Mixing,
Flow chart for Direct Mixing for the manufacturing of Dry Syrup:
Crushing the sucrose in 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
· Machines used in the Dry Syrup Manufacturing unit:
|Name of the Machine||Function|
|Double cone Blender||Blending/Mixing|
|Bottle Filling Machine||Filling of Dry Syrup|
|Bottle Sealing Machine||Sealing of Dry Syrup Bottle|
· Condition for manufacturing Dry Syrup:
· Relative Humidity: Not more than 45%.
· Temperature: Below 270
Purpose of packaging:
· To increase the acceptability of the drug
· To increase the stability of the drug
· To minimize the transport/shipping hazards
· To improve patients compliance
· To improve the pharmaceutical elegance by use of special color or contrasting printing
At Navana Pharmaceuricals Ltd. Three types of combination is use depending on the upper & lower layers as well as product requirement. They are;
· PVC-Aluminium Blister
· Aluminium -Aluminium Blister
· PVDC- Aluminium Blister
Besides blister packaging, at other packaging includes;
· Striping ‹Alu-Alu›
· Filling of tablets &capsules in bottles
· Labeling of bottles
· Secondary Packaging (Both on-line & off-line)
Name Model source capacity
Automatic blister DPP-250DII China 60000/hr
MINISTAR VAT Automatic M.S dal Hooga-A South Korea 12000-90000/hr
blister Packing Machine
Automatic Strip Leo-4 India 30000/hr
?Alu.Foil (Blister/Strip) ?PVC/PVDC Film
?Alu-Alu Foil(Bottom) ?PP Cap
?Label ?Unit Carton
?Inset ?Plastic Spoon
?Plastic Cap ?Stopper
?Shipping Carton ?Cotton.
Fig: Aluminium foil
Fig: Blister machine
NAME OF THE PVC/PVDC FILM USED:
Name of the item Width (mm) Thickness (mm)
- Coffee brown 146 0.250
- Glass Clear 160 0.250
- Glass clear PVDC 202 0.350
- Alu-Alu Bottom 221 0.250
Name of the Bottle size:
- 35 ml bottle Round Amber
- 70 ml bottle Round Amber
- 100 ml bottle Round Amber
- 130 ml bottle Round Amber
- 200 ml bottle Oval
- Plastic Container with Cap & Washer
Primary Packaging Materials:
Automatic Blister Packing Machine:
?Bottle Foil (P.V.C) uncoiler ?Drive Motor
?Pre-heating & forming station ?Pneumatic Circuit
?Hopper ?Sealing Station
?Feeding System ?Cooling & Slitting System
?Cover Foil ?Punching Station
?Embossing Station ?Waste Foil coiler
?Conveyor ?Refrigerator & Cooling Unit
Flow Chart of Blister packaging Machine:
Pocket formation (By Compression air & temperature)
Filling Station (Channel, feeder, dosage channel)
Automatic Strip Packing Machine:
Flow Chart of Strip packaging Machine:
Sealing (temperature station)
Secondary Packaging (Both on-line & off-line):
Secondary packaging includes-
· Unit Cartooning with
-Spoon/dropper (in case of liquid)
-Security seal/ Hologrammed Seal
· Master Cartooning with
– Unit cartoons
- Observation no.
- Leak test
- Room condition
a) Temperature & humidity
b) Segregation of bulk materials/finished packs
c) Product identity
d) line, display board
5. Aluminum foil leaving in machine and stock
6. Number of individual strips/blisters checked
7. Number of finished products checked
8. Quality and identity of components compliant slip/labels/cartons/leaflets/outer labels/outer box/ spoon
9. Identity and appearance of product in packs
10. Quantity: No./volume/weight
11. Overprinting/embossing: batch no./MFD/Exp date/MRP
12. Label/carton with product name, batch no., Mfg date, price and Exp date.
Oral liquid preparations include-
· Oral Syrup
General Manufacturing Process of Oral Liquids:
The general manufacturing of oral liquids in the liquid section of Navana Pharmeceuticals Ltd isbriefly described below with a flowchart;
Weighing of active ingredient/s along with excipients
Mixing of excipients with certain amount of demineralized (DM) water as specified in the Batch Production Record (BPR) by the aid of a mechanical stirrer
Addition of active ingredient/s
Passing through a pump to the storage vessel to the
Transfer of the solution to the filling vessel through 0.5m Cartridge filter.
Filling, Flushing of Nitrogen (N2) & Sealing of Bottles (glass or pet) containing oral liquids
Machines used in the Oral Liquid & Suspension Manufacturing units:
Name Speed Source
Variable speed stirrer 1400rpm India
Emulsifying Stirrer 2800rpm China
Horizontal Filter Press 1400rpm India
Inline emulsifier mixer 800 rpm India
Colloid mill 2810rpm England
Stainless steel Vessel
Cap sealing Machine.
Fig: Inline emulsifier mixer
Condition for manufacturing of Oral Liquids:
· Relative Humidity: Not more than 55%.
· Temperature: Below 300
Steps involved in Suspension Preparation:
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
Research and Development:
To launch a new product, the Research and Development department develops a formulation and manufactures the product on a laboratory scale. The stability tests are performed on these new products. After passing the tests the product is manufactured commercially. Research & development department prepares the manufacturing instruction, coating instruction (if necessary), packaging instruction, product specification and testing procedure file of the new product.