Orion Laboratories Ltd. is one of the premier pharmaceutical companies of Bangladesh
COMPANY PROFILE
Orion Laboratories Ltd. is one of the premier pharmaceutical companies of Bangladesh with a proven track record for manufacturing and marketing branded generic pharmaceutical products. Having four decades of vast experience imbibed with technical and professional expertise, now Orion levers a wide array of therapeutic areas. Orion has now more than 70 generics in a wide range of dosage form and strengths including life-saving indictable.
History of the Company
Orion Laboratories Ltd (OLL) a member of Orion group was founded as a pharmaceutical manufacturing company in 1965 with its modest start nearly of four decades with the mission to serve the ailing humanity around the globe. OLL has today burgeoned out into one of the leading pharmaceutical company in Bangladesh among 216. It has already established itself to the doctor’s community, other health care professionals, chemists and patient as provider of quality medicines and health care services through 50 brands and 51 presentations of various formulations. Since its humble beginning in 1965, ORION has made giant strides to establish itself as one of the leading pharmaceutical companies in the intensely competitive pharmaceutical market.
ORION has been able to make its very strong ethical presence felt in the community as accompany with vision.
Company pursues, follow and maintain the latest World Health Organization (WHO) approved all standards of Good Manufacturing Practices (GMP), in every step, from the procurement of raw materials to the manufacturing of finished products. A highly skilled, dedicated and enthusiastic team of professionals, comprising of pharmacists, biochemists, chemists, microbiologists, engineers, doctors and other are making relentless efforts in manufacturing and marketing quality pharmaceutical products at affordable prices for the people of Bangladesh.
Leading Edge
Orion has gained a leading edge in many important therapeutic groups including Antimicrobial Agents, Antihypertensive, Anti-ulcerants & Antacids, Antihistamines, Antidiabetics, Antipyretic/Analgesics, Anxiolytics, NSAIDs, Diuretics, Cardiovascular drugs, Vitamin & Mineral supplements, Hypoglycemic Agent & Tranquilizer.
Flagship Products
Enliven (Imatinib Mesylate), Pep (Zinc Sulphate Syrup), Ortac (Ranitidine), Clog nil (Clopidogrel) and EC-plus (Vitamin E and C) are the major flagship products, which are the deserving pride of Orion.
Trust to Excel
Orion Laboratories Ltd. has more than just the reputation to keep up. Always “In search of excellence”. ‘Quality’ and ‘Affordability’ are my major concerns while operating my business. , at Orion, refuse to settle for anything until it exceeds the existing standard and until it becomes affordable.
Iso Certification
Orion has strong ethical commitment and has been awarded with the ISO-9001: 2000 Certificate in January, 2003 for serving its valued customers with products of excellent quality.
UNICEF Accreditation
As recognition of high standard Quality Assurance using modem machinery, Orion has achieved the recommendation of UNICEF as a “Potential Medicine Supplier of UNICEF”.
Quality Policy
Orion Laboratories Ltd. is dedicated to serve its valued customers with products of excellent quality through continuous improvement in technology, process and human resources complying with the guidelines of Good Manufacturing Practice (GMP) and the requirements of 150-9001: 2000 Quality Management System (QMS).
Vision of Orion
Orion believes in ‘Quality in everything they do’. Their vision is ‘To be regarded as a world-class pharmaceutical company through products and services’.
Mission of Orion
Their mission is to provide health care services to the ailing humanity round the globe by:
- Continuous development of people competence
- Recognizing individual contribution
- Introducing new as well as innovative products and technologies.
- Assuring quality products from advanced manufacturing facilities.
- Exceeding customer satisfaction and gaining trust through quality services.
- Expanding the export market.
Values of Orion
In order to achieve its aspired vision, Orion Laboratories Ltd. subscribes the following values:
- Quality in everything they do
- Live up to my commitments
- Transparent and fair in all my dealings
- Take initiative to exceed standards
- Trust and respect for each other
- Work as a team
- Share social responsibility
Talent and Resources of Orion
Orion boats a team of the sharpest mindsets in Bangladesh Pharmaceutical Market backed up with an excellent group dynamics of administrative, marketing and service professionals. With its more than 500 well-motivated field colleagues and 350 Distribution Personnel in 13 distribution-cum-sales centers throughout the country, Orion has been able to promote and distribute its products as per customer need.
A Mind Set to Never Give Up
NECESSITY OF IN-PLANT TRAINING
Orion believes in ‘Quality never ends’. So, Orion stands for ceaseless efforts to improve its products and processes for further development. Keeping in mind of its motto “Quality in Everything I Do” Orion always hunts technological challenges presented by enterprising customers as well as leading profession.
A pharmacist is the person of drugs or the expert on drugs. S/he is the only expert on drugs, for expertise regarding drugs requires knowledge in depth in all the facts of pharmacy. It is his/her professional responsibility to know all about the drugs. No educational program other than that in pharmacy provides the background to understand completely all about drugs.
Among the professions of pharmacists like community pharmacy, institutional pharmacy, whole sale pharmacy, industrial pharmacy, government service, pharmaceutical education, organizational management, in my country industrial pharmacy offers great opportunity to the pharmacists.
Industrial pharmacy is a profession of unique hybrid of business and profession.
So an industrial pharmacist should have proper knowledge about drugs and also about medical progress, commence marketing and technology. To be a self-sufficient pharmacist beside academic knowledge, practical knowledge is essential.
This is why after appearing the Bachelor of Pharmacy examination in-plant training was arranged by the discipline in renowned ORION Laboratories Ltd.. This training has sharpened our academic knowledge what we learnt in the last few years .We have completed training in Orion Laboratories Ltd. a fast growing pharmaceutical company in Bangladesh.
PRODUCTION DEPARTMENT OF ORION
The production area in Orion Laboratories Ltd. Can be divided into the following sections:
1. Tablet section
• Granulation
• Compression
• Coating
2. Liquid Processing and Filling section
3. Capsule section
• Manual
• Auto
4. Dry Syrup section
• Blending
• Filling
5. Packaging section
• Blister packing
• Vitamin packing
• DIS packing
6. Warehouse(RM & PM)
7. Maintenance
8. Finished Product Store
9. Sterile Section
TABLET SECTION
Tablet
Tablet Section
Tablets may be defined as the solid unit dosage form of medicament or medicaments with or without suitable diluents or excipients and prepared either by molding or by compression. They vary greatly in shape, size and weight which depend upon the amount of medicament and the mode of administration. Excipients may include diluents, binders, disintegrating agents, lubricants, sweetening agents, flavoring and coloring agents.
Advantage
Tablets have following advantages:
- Easy to carry.
- Easy to swallow and may provide the greatest ease of swallowing with the least tendency for “hang-up” above the stomach, especially when coated, provided that tablet disintegration is not excessively rapid.
- They lend themselves to certain special – release profile products, such as enteric or delay-release products.
- Attractive in appearance.
- Unpleasant taste can be masked by coating.
- Do not require any measurement of dose.
- Can be divided into halves and quarters by drawing lines during manufacturing to facilitate breakage whenever a fractional dose is required.
- An accurate amount of medicament even if very small can be incorporated.
- Tablets provide prolong stability to medicament.
- The incompatibilities of medicaments and their deterioration due to environmental factors are less in tablet form.
- Since they are generally produced on a large scale therefore their cost of production is relatively low.
- They have the best combined properties of chemical, mechanical and microbiologic stability of all the oral forms.
During training we have observed the manufacturing of the following tablets:
· Nidazyl
· EC Plus
· Deslor
· Maxical Plus
Different solid manufacturing unit
The different solid manufacturing units are:
§ Dispensing unit
§ Granulation unit
§ Dry granulation
§ Wet granulation
§ Compression unit
§ Coating unit
§ Packaging unit
Dispensing Unit
The manufacturing unit sends a demand paper according to their need, to the warehouse. Central Dispensing Unit weighs the required amount of active ingredient & excipients and then sends it to the manufacturing unit. Manufacturing unit received and rechecked it. Raw materials must be approved from QC department before dispensing.
Granulation unit
There are two types of granulation:
1. Dry granulation
2. Wet granulation
Instruments / Apparatus Used in Granulation:
There are various types of sophisticated instruments are used for the purpose of materials mixing. The instruments are
| SI
No |
Name of the machine | Source | Capacity |
| 01 | Horizontal Mass Mixture | Bangladesh | 120 Kg |
| 02 | Planetary Mass Mixture | India | 100 Kg |
| 03 | Solace Mass Mixture | India | 50 Kg |
| 04 | Tone Mixture | India | 15 Kg |
| 05 | Double Corn Mixture | India | 20 Kg |
There are various types of sophisticated instruments that are used for the purpose of
granulation. The instruments are
| SI
No |
Name of the machine | Model no | Company | Source | Capacity |
| 06 | Fluid Bed Dryer | TR30E | Alliance | India | 30 Kg |
| 07 | Fluid Bed Dryer | BF-60 | Bombay | India | 60 Kg |
| 08 | Fluid Bed Dryer | TR60E | Alliance | India | 60 Kg |
Steps of Dry Granulation
Raw Material (Active + Excipients)
?
Mixing (Except Lubricant)
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Blending at V- shaped or Cone blender for 10-30 minutes
?
Add lubricant
?
Blending for 5-10 minutes
?
Quality Control (For Approval)
?
Compression
Steps of Wet Granulation
Raw Material (Active + Excipient)
?
Sieving with the mesh size of 24
?
Mixing at Horizontal Mass Mixture for 30 minutes (Dry Mixing)
?
Wet Mixing for 80-90 minutes (Add binder and starch paste)
?
Drying at Fluid Bed Dryer for 40 minutes to 3 hours
?
Milling at multimill (Mesh size 3 or 5)
?
Sieving (Mesh size 12 or 16)
?
Final drying
?
Loss on Drying (Consider maximum 1%)
?
Adding lubricant (Which increase flow properties)
?
Quality Control
?
Compression
Compression Unit
After proper blending granules are stored in a container and then it is delivered to the compression unit. Before compression some parameters are checked:
· Proper cleaning of machine.
· Proper arrangement of die and punch.
· Removal of all the material relevant to previous product
· HVAC system.
· Dust collecting system
· Humidity
· Temperature
· Pressure differential
· Granules are poured into hopper
Tablet compression
For the compression of granules in the form of tablets, various types of machines are used which are known as tablet making machines or tablet presses. Various types of machines so used are as follows:
1. Single punch machines.
2. Multi punch machines.
3. Rotary tablet machines.
4. High-speed rotary tablet machines.
5. Multilayer rotary tablet machines.
During our training we have familiar with various types of machines used in tablet compression. These are as follows
Instruments / Apparatus Used In Tablet Manufacturing
| SI No. | Name of the Machine | Model No. | Punch No. | Capacity
(Per Hour) |
Source |
| 01 | CADMACH-1 | CMD-3B-16 | 16 | 30000 | India |
| 02 | CADMACH-2 | CMD-4D-27 | 27 | 100000 | India |
| 03 | CLIT | CJD-3 | 16 | 30000 | India |
| 04 | ZPT | ZPT-23 | 23 | 150000 | China |
Steps of tablet compression
Granules or Materials (Raw Materials + Excipients)
?
Hopper
?
Tarat
?
Materials in the die hole through feed fram
?
Pressure with upper and lower punch through upper and lower roller
?
Tablets
Problems, which may arise during manufacturing
· Binding in the die.
· Capping and lamination
· Chipping, picking and sticking
· Mottling
· Hardness variation
· Weight Variation
· Double Impression
Coating Unit
Coating is one of the important steps after compression. The various objectives of coating are as follows
Objectives
· To mask the taste, odor or color of the drug.
· To provide physical and chemical protection for the drug.
· To control the release the drug from the tablet.
· To protect the drug from gastric environment of the stomach with an acid-resistant enteric coating.
· To improve the pharmaceutical elegance by use of special colors and contrasting printing.
Instruments / Apparatus Used In Tablet Coating
There are various types of sophisticated instruments are used for the purpose of tablet coating. The instruments are
| SI No. | Name of the Machine | Model | Company | Source | capacity
(Kg) |
| 01 | RAMA-1 | 27 | N. R. Narongkarmchang. Co. Ltd | Thailand | 20-30 |
| 02 | RAMA-2 | 39 | N. R. Narongkarmchang. Co. Ltd | Thailand | 100 |
| 03 | ECO COTA | 900 | FD & C Equipment (Pvt) Ltd | Pakistan | 100 |
Types of coating
- Sugar coating.
- Film coating.
- Compression coating.
- Enteric coating.
During my training we observed Film coating. There are two types of film coating
- Aqueous coating
- Organic solvent coating
Film coating
Film coating involves the deposition, usually by a spray method, of a thin film of polymer surrounding the tablet core.
Ingredients used in film coating
Typically a coating formulation (solution or suspension) contains following ingredients—
Polymer
· Cellulose derivatives (Hydroxypropylmethyl cellulose, hydroxyethyl cellulose, methyl cellulose, cellulose acetate phthalate etc)
· Methacrylate amino ester copolymer (Eurasia,)
· Polyvinyl acetate phthalate (Opadry, Opaglos, Nutrateric, Sureteric)
Plasticizer
· Polyhydric alcohols (glycerol, propylene glycol, polyethylene glycol etc)
· Organic esters (diethyl phthalate, triethyl citrate etc)
· Oils or glycosides (castor oil, acetylated monoglycerides etc)
Solvents
· Water
· Alcohols (methanol, ethanol, isopropanol etc)
· Esters (ethyl acetate)
Colorants
· Iron oxide pigments
· Titanium dioxide
· Aluminum lakes
Important critical parameters to check prior to spray coating solution
· Pump speed
· Pan Rotation
· Bed Distance
· Negative Pressure
· Inlet Air Temperature
· Outlet Air Temperature
· Atomizing Air Pressure
· Fluid Return Volume
· Nozzle to nozzole Distance
· Nozzle Distance from the Tablet Bed
Coating Procedure
Coating solution (Aqueous or Non aqueous)
?
Filtering (Need for only in non aqueous solution)
?
Tablets into coating pan
?
Dedusting
?
Heating (For aqueous 70? C & non aqueous 55? C)
?
Spray by spray gun
?
Polishing (Opadry clear or PEG-6000)
?
Drying at 40? C-45? C for 1-2 hours
Problems, which may arise during coating
· Sticking & Picking.
· Roughness.
· Orange-Peel Effects.
· Color variation.
· Cracking.
· Edge chipping/Erosion.
· Logo bridging.
· Logo infilling.
· Twinning.
· Core erosion.
IN-PROCESS QUALITY CONTROL
· Weight variation
· Hardness Test
· Friability Test
· Disintegration
During tablet manufacturing, the raw materials needed for a batch of drugs are taken from the Warehouse (RM&PM) department after accurate weighing and to the production area. These materials then go for granulation, milling, blending and drying processes as required. Plain tablets and tablets cores are produced in the various compression rooms using the machinery listed previously.
After compression, many tablet cores get a coating. Products then wait in quarantine area in Finished Goods Store, until the quality control laboratory confirms their standardized quality and authorizes their release. The whole process of tablet manufacturing ensures “Good Manufacturing Practice.”
LIQUID PROCESSING, FILLING &
PACKAGING
LIQUID PROCESSING, FILLING AND PACKAGING
The oral use of liquid Pharmaceutical has generally been justified on the basis of ease of administration to those who have difficulty in swallowing solid dosage form. 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 section oral suspension, syrup etc. are manufactured. During my visit, I have observed the manufacturing of
- Deslor syrup
- Orioplex syrup
- Pep-2 syrup
Machines used
- Syrup preparation vat Capacity : 400L
- Process vat Capacity : 1200L
- Process vat Capacity : 500L
- Stirrer machine Capacity : 60 rpm
- Transfer pump
- Filter Machine
- Colloid Mill
- Liquid Filling Machine
- Capacity: 30-40 Bottle/Minute.
- Liquid Sealing Machine
Flow diagram of liquid manufacturing
Sugar syrup (Heat85-95ºC) conc.40-65% + Excipients
Step 1: Syrup base
Cooled 40-60ºC
Step 1.1: Presecrutives
Solution
Step 2: Filtration
Step 2.1: Dispersed thickening Step 2.2: Slurry of active ingredient
Agent, if necessary
Step 2.3: buffering agent Step 2.4: Flavoring agent
PH adjusters
Step 2.5: colorants
Step 3: Volume adjustment
Liquid filling
Flow diagram of liquid filling
(a)
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Liquid packaging
There are two type of packaging-
· Primary packaging
Syrup/Elixir/Emulsion: These products are filled into clean glass bottle and sealed by automatic bottle filling and sealing machine
· Secondary packaging
· Cartooning/Box: After primary packing products are pack into paper/printed cartoon. In this time, Batch no. Mfg date, Exp date must be check and maintain strictly.
· Master cartooning: Small individual cartoons or boxes are pack into fibre board cartoon according to batch no, it is called master cartooning.
CAPSULE SECTION
CAPSULE
Capsules are the solid unit dosage form of medicament in which the drug(s) is enclosed in a practically tasteless, hard or soft soluble container or shell made up of a suitable form of gelatin.
Gelatin shells are supplied in a number of sizes. The number varies from 000 to 5, the former being the largest and later the smallest. The exact amount of a medicament which can be filled in a particular size of capsule shell depends upon density of the material to be filled in. Generally the capacity varies from 600mg to 30mg.
Advantages
- Capsules are tasteless, odorless and can be easily administered.
- Attractive in appearance.
- The drugs having unpleasant odor and taste are enclosed in a tasteless shell.
- They can be filled quickly and conveniently therefore the physician can change the dose and combination of drugs to suit the individual patient. This is an advantage over tablets.
- Flexibility in onset and duration of action also contribute to the suitability of the capsule as a pharmaceutical dosage form.
- Ease of formulation.
- Limited potential for incompatibilities.
- Good stability.
- Easy to swallow.
- They are economical.
- They are easy to handle and carry.
Disadvantage
· Capsules are not usually used for the administration of extremely soluble materials such as potassium chloride or ammonium chloride.
· Capsules should not be used for highly effervescent or deliquescent materials. Effervescent materials may cause the capsule to soften.
· Deliquescent powders may dry the capsule shell to excessive brittleness.
· The concentrated solutions which require previous dilution are unsuitable for capsules because if administered as such lead to irritation in the stomach.
Capsule shell has two parts: Body and cap. Several designs of locking systems in the capsule shells are available.
During my visit I have observed the manufacturing of following capsules.
· ORIXYL
· GLORY
· PROCAP
· ENLIVEN
Flow Diagram Of Capsule Processing:
Process 1 (For Pellet)
Weighing
Dispensing
Blending
Encapsulation
Process 2 (For Powder) Weighing
Dispensing
Blending
Slugging
Sieving
Granulation
Encapsulation
Process of capsule filling:
· Manual
· Auto
Procedure of Manual Capsule Filling
Capsule shells are set into the plate through insetter
?
Plate set into the hand filler
?
Body and cap separated by scissor
?
Fill the body with materials
?
Attached body and cap
?
Capsules
Machines Are Used
· Hand filling machine(300 pores per plate)
· Insetter machine (India)
· Balance machine (Powder wt / Capsule wt)
Procedure of automatic Capsule Filling
Capsule shells into the hopper
?
Meggine
?
Cap boos and body boos
?
Filling materials from chemical hopper
?
Checking
?
Close the body and cap by closing pin
?
Capsule open from the boos by capsule open pin
?
Capsules
Instruments / Apparatus Used In Automatic Capsule Filling
There are various types of sophisticated instruments are used for the purpose of capsule filling. The instruments are-
| SI No. | Model | Company | Source | Capacity |
| 01 | AF25T |