Necessity of in-plant training
A pharmacist is the person of drugs or the expert on drugs. He is the only expert on drugs, for expertise regarding drugs requires knowledge in depth in all the facts of pharmacy. It is his 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 our country industrial pharmacy offers great opportunity to the pharmacists.
Industrial pharmacy is a profession of unique hybrid of business and profession.
So a 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 department in renowned pharmaceuticals industries. This training has sharpened our academic knowledge what we learnt in the last four years .We have completed our training in Orion Laboratories Ltd. a fast growing pharmaceutical company in Bangladesh.
COMPANY PROFILE
Orion Laboratories Ltd.
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 off 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 injectables.
History of the Company
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. The 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 Anticancer, Antidiabetics, Antioxidants, Antiulcerants and Cardiovascular drugs.
Flagship Products
Enliven (Imatinib Mesylate), Pep (Zinc Sulphate Syrup), Ortac (Ranitidine),Clognil (Clopidogrel) and EC-plus (Vitamin E and C) are the major flagship products, which are the deserving pride of Orion.
Trust to Excelllence
Orion Laboratories Ltd. has more than just the reputation to keep up. We are always “In search of excellence”. ‘Quality’ and ‘Affordability’ are our major concerns while operating our business. We, at Orion, refuse to settle for anything until it exceeds the existing standard and until it becomes affordable.
Award of Excellence
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 IS0-9001: 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 our commitments
- Transparent and fair in all our 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 mindset to never give up
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 We Do” Orion always hunts technological challenges presented by enterprising customers as well as leading profession.
Organization structure of Orion Lab. Ltd
Tablet Section
Tablets are solid dosage forms with or without suitable excipients, which are prepared either by compression or by molding methods. Excipients may include diluents, binders, disintegrating agents, lubricants, sweetening agents, flavoring and coloring agents.
Objectives
- They are a unit dose form, and they offer the greatest capabilities of all oral doses forms for the greatest dose precision and the least content variability.
- Their cost is lowest of all oral dosage forms.
- They are the lightest and most compact of all oral dosage forms.
- They are in general the easiest and cheapest to package and ship of all oral dosage forms.
- Product identification is potentially the simplest and cheapest, requiring no additional processing steps when employing an embossed or monogrammed punch face.
- They 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.
- They are better suited to large-scale production than other unit oral forms.
- They have the best combined properties of chemical, mechanical and microbiologic stability of all the oral forms.
During our training we have observed the manufacturing of the following tablets
Nidazyl
EcPlus
Deslor
Machines used
Mixing
- Horizontal mass mixture
- Capacity – approximately 120 Kg
- Source – Bangladesh.
- Planetary mass mixture
- Capacity – approximately 100 Kg
- Source – India.
- Solace mass mixture
- Capacity – approximately 50 Kg
- Source – India.
- Tone mixture
- Capacity – approximately 15 Kg
- Source – India.
- Double cone mixture
- Capacity – approximately! 20 Kg
- Source – India.
- Solace mass mixture
Drying
- Fluid bed dryer
- Company: Alliance
- Capacity – 60kg/hr
- Source – India.
- Fluid bed dryer
- Company Alliance
- Capacity-30kg/hr
- Source – India.
Compression
- Cadmach-l
It has 16 dyes
Capacity-30-35000kg,hr
Source – India.
- Cadmach-2:
It has 27 dyes
Capacity-80-90000kg/hr
Source-India.
- Clit:
It has 16 dyes
Capacity-30-35kg/hr
Source-India.
Blending
Solace multimill
Source-India.
Seaving
- o Siftern:
12,16,20,24 mesh size net
Source-India.
Lubricating
- V-blender
Capacity: 200kg
Source
| Relative merits and demerits of granulation process | ||
| Wet granulation | Dry granulation | Direct compression |
| Most widely used technique | Not widely used technique | |
| Not suitable for moisture sensitive product | Suitable for moisture sensitive product | Suitable for moisture sensitive product |
| Require many steps | Require few steps | Require only two steps |
| Not suitable for heat sensitive products | Require a special compactor machine for granulation | Not suitable for high tablets |
Problems, which arise during manufacturing
- Capping and lamination
- Chipping, picking and sticking
- Mottling
- Hardening
- Weight Variation
- Double Impression
COATING
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.
Coating machine:
RAMA 1
Capacity: 20-30kg
Source: Thailand.
RAMA 2
Capacity: 50-100kg
Source: Thailand.
QECOCOTA
Capacity: 50-100kg
Source: Pakistan.
Types of Coating
Coating is mainly two types.
- Sugar coating &
- Film coating.
Mainly we have observed here Film coating.
Procedure of Film coating
a) Preparation of color solution.
b) Loading tablet in to pan.
c) Attachment & adjustment the spray nozzle to spray on upper half of tablet bed.
d) Turn on heat, drying air. exhaust, and atomizing air.
e) Intermittently jog the pan while tablets are warming.
f) Start spraying when exhaust temp reaches 30″c.
g) Apply color solution at definite rate.
h) Allow tablet to dry in pan with air heat for desired minutes.
Problems, which may arise during coating
a) Sticking & Picking.
b) Roughness.
c) Orange-Peel Effects.
d) Color variation.
e) Cracking.
In-process Quality Control
1) Weight variation
2) Hardness Test
3) Friability Test
4) 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”
Machines are used-
a) Hand filling machine(300 pores per plate)
b) Insetter machine (India)
c) Balance machine (Powder wt / Capsule wt)
Auto filling
Machines are used-Automatic capsule filling machine (Capacity25000/hr, Source-India) Vacuum pump machine
| Relative merits and demerits | of Manual filling & Auto filling: |
| Manual filling | Auto filling |
| Time consuming | Less time consuming |
| Re-polishing necessary | Not necessary |
| More worker needed | Less worker needed |
DRY SYRUP
In manufacturing area, we have visited dry syrup section. During our visit, we have observed the manufacturing of
Mac Dry Syrup
Sefin Dry Syrup
Orixyl DS Dry Syrup
Machines Used
v Double Cone Mixture Machine
Capacity-120 kg.
Source-Bangladesh.
v Filling Machine: Hopper Filler
Delivery rate-450-500Tir
Source-Canada.
v Sealing Machine
Delivery rate-3 8 bottle/min
Source-Bangladesh.
Precaution:
Humidity & Temperature must be controlled. (Dehumidifier is necessary for that.) Worker must be well garmented
LIQUID SECTION
In liquid section oral suspension, syrup etc. are manufactured. During our visit, we have observed the manufacturing of
Pep
Pep-2.
Machines Used
Syrup preparation vat Capacity : 400L
Process vat Capacity : 1200L
Process vat Capacity : 500L
Stirrer machine Capacity : 60 rpm
Transfer pump
Filter Machine
WARE HOUSE (RM&PM)
The Ware House of ORION Laboratories Ltd is more or less well organized. Various Tags with different colors are used to identify the materials easily in the storage area in specific space.
Raw Materials Storage Area
a) Quarantine area -To be truthful it is so called in ORION Laboratories Ltd. After receiving of raw materials they are stored first in the quarantine area. Then Q.C. sampling and checking is approved and then shifted to the main storage area, which is escorted by grille.
b) Main storage area- Here raw materials are stored. There is another isolated storage area for sophisticated materials maintaining temperature and humidity in side the main storage area. The storage department performs some important functions such as
- i. Specific raw materials are stored in specific mentioned area with proper documentation.
- ii. According to monthly program, this department has the responsibilities to get final Q.C. approval for raw materials.
- iii. According to plan and recovery maintenance, the raw materials are supplied to the production area for required batch size.
Storage Area for Packaging Material
Packaging material including master pack, carton, foil, inner pack, catch cover etc are stored here.
Weighing area:
There is an isolated area with humidity & temp control for weighing. From here materials are supplied to the production area by accurate weighing in presence of Q. C. officer.
Storage Area for rejected Samples
Some samples are unfortunately rejected; these are stored in this section with red color tag. Viewing this tag someone understands products are rejected will go further to Q. C. department.
