Orion Laboratories Ltd. is one of the premier pharmaceutical companies of Bangladesh.
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.
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.
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.
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.
As recognition of high standard Quality Assurance using modem machinery, Orion has achieved the recommendation of UNICEF as a “Potential Medicine Supplier of UNICEF”.
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
2. Liquid Processing and Filling section
3. Capsule section
4. Dry Syrup section
5. Packaging section
• Blister packing
• Vitamin packing
• DIS packing
6. Warehouse(RM & PM)
8. Finished Product Store
9. Sterile 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.
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:
· EC Plus
· 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
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.
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
NoName of the machineSource Capacity01Horizontal Mass MixtureBangladesh120 Kg02Planetary Mass MixtureIndia100 Kg03Solace Mass MixtureIndia50 Kg04Tone MixtureIndia15 Kg05Double Corn MixtureIndia20 Kg
There are various types of sophisticated instruments that are used for the purpose of
granulation. The instruments are
NoName of the machineModel noCompanySource Capacity06Fluid Bed DryerTR30EAllianceIndia30 Kg07Fluid Bed DryerBF-60BombayIndia60 Kg08Fluid Bed DryerTR60EAllianceIndia60 Kg
Steps of Dry Granulation
Raw Material (Active + Excipients)
Mixing (Except Lubricant)
Blending at V- shaped or Cone blender for 10-30 minutes
Blending for 5-10 minutes
Quality Control (For Approval)
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)
Loss on Drying (Consider maximum 1%)
Adding lubricant (Which increase flow properties)
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
· Pressure differential
· Granules are poured into hopper
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|
Steps of tablet compression
Granules or Materials (Raw Materials + Excipients)
Materials in the die hole through feed fram
Pressure with upper and lower punch through upper and lower roller
Problems, which may arise during manufacturing
· Binding in the die.
· Capping and lamination
· Chipping, picking and sticking
· Hardness variation
· Weight Variation
· Double Impression
Coating is one of the important steps after compression. The various objectives of coating are as follows
· 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)01RAMA-127N. R. Narongkarmchang. Co. LtdThailand20-3002RAMA-239N. R. Narongkarmchang. Co. LtdThailand10003ECO COTA900FD & C Equipment (Pvt) LtdPakistan100
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 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—
· Cellulose derivatives (Hydroxypropylmethyl cellulose, hydroxyethyl cellulose, methyl cellulose, cellulose acetate phthalate etc)
· Methacrylate amino ester copolymer (Eurasia,)
· Polyvinyl acetate phthalate (Opadry, Opaglos, Nutrateric, Sureteric)
· Polyhydric alcohols (glycerol, propylene glycol, polyethylene glycol etc)
· Organic esters (diethyl phthalate, triethyl citrate etc)
· Oils or glycosides (castor oil, acetylated monoglycerides etc)
· Alcohols (methanol, ethanol, isopropanol etc)
· Esters (ethyl acetate)
· 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 solution (Aqueous or Non aqueous)
Filtering (Need for only in non aqueous solution)
Tablets into coating pan
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.
· Orange-Peel Effects.
· Color variation.
· Edge chipping/Erosion.
· Logo bridging.
· Logo infilling.
· Core erosion.
IN-PROCESS QUALITY CONTROL
· Weight variation
· Hardness Test
· Friability Test
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 &
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
- 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
Step 1.1: Presecrutives
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
Step 2.5: colorants
Step 3: Volume adjustment
Flow diagram of liquid filling
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.
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.
- 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.
· 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.
Flow Diagram Of Capsule Processing:
Process 1 (For Pellet)
Process 2 (For Powder) Weighing
Process of capsule filling:
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
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
Cap boos and body boos
Filling materials from chemical hopper
Close the body and cap by closing pin
Capsule open from the boos by capsule open pin
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-
|01||AF25T||PAM Pharmaceuticals & Allied Machinery Company (Pvt) Ltd||India||25000/ hour|
|02||AF40T||PAM Pharmaceuticals & Allied Machinery Company (Pvt) Ltd||India||40000/ hour|
|Relative merits and demerits||of Manual filling & Auto filling:|
|Manual filling||Auto filling|
|Time consuming||Less time consuming|
|Repolishing necessary||Not necessary|
|More worker needed||Less worker needed|
During manufacturing time the room condition must be in control system. The room temperature should be in between 22-250c and room humidity 40 + 5%.
DRY SYRUP Section
In manufacturing area, we have visited dry syrup section. During our visit, we have observed the manufacturing of –
Instruments / Apparatus Used In Dry syrup manufacturing:
No NameCapacitySource1.Double cone mixture machine120 kgBangladesh2.Filling machine: Hopper machineDelivery rate:450-500TirCanada3.Sealing machine3-8 Bottles /minBangladesh
Flow chart of Dry syrup manufacturing:
Humidity & Temperature must be controlled. (Dehumidifier is necessary for that.) Worker must be well garmented.
In the pharmaceutical industry, it is vital that the package selected adequately preserve the integrity of the product. The selection of a package therefore begins with a determination of the products physical and chemical characteristics, its protective needs, and its marketing requirements.
The packaging materials selected must have the following characteristics.
· They must protect the preparation from environmental conditions.
· They must not be reactive with the product
· They must not impart to the product tastes or odor
· They must be non-toxic
· They must be FDA approved
· They must applicable temper-resistance requirements
· They must be adaptable to commonly employed high speed packaging equipment.
In packaging I observed
· Blister packing
· Vitamin packing
· Dry syrup packing
During my training I have seen Blister packaging of
· KETORIN( INJECTABLE)
During my training I have seen
- Making catch cover for physician STIMULIN.
- Making master carton of NIDAZYL NICOR
- Box carton packing of SEFIN
The materialsused for Blister packing are Aluminum foil, PVC, PVDC. In Dry syrup bottle I have seen shrink tubing
Label or box must have:
· Product name
· Generic name
· License no
· DAR No
· Address& name Manufacturing Company.
· Batch no.
· Manufacturing Date
· Expiration Date
· I have seen another printing machine that is Video Zet Printer
Finished Products Store
All the finished products are stored here with care. From the marketing Department’s desire this department delivery the produc
Common Procedure of The Blister Packaging Is
PVC from PVC ruler
PVC passes through the heater for the softness
Forming station (Pocket form by vacuum pressure)
Channel or Gidel (It contains or carries the PVC with pocket)
Pusher (It helps to set out the ampule or vial)
Sealing station Alu Foil
PVC – Alu or Alu – Alu attached by heater
Cooling the blister
Instruments / Apparatus Used In Blister Packaging
There are various types of sophisticated instruments are used for the purpose of blister packaging. The instruments are
|SI No||Model no||Company||Source|
|03||Wider-AIII||BUCHON Machinery Company Ltd||Korea|
In pharmaceutical market few companies ensure qualitative products. ORION Laboratories Ltd is one of them. Now a days, manufacturing of quality product is quite difficult from the raw materials to the finished product in each and every step quality operation department plays a very important role. Quality Assurance Department is very important for a pharmaceutical industry to maintain G.M.P. The concept of total quality management and total 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. Although the responsibility for assuring product quality belongs principally to Quality Assurance Department, it involves many departments and disciplines within the company. To be effective it must be supported by a team effort. The Quality Assurance Department is vital for a pharmaceutical industry since it controls and assures the quality of the products starting from the raw materials.
Quality Assurance department is consist of four sections, those are:
Functions of Quality Assurance Department
· Raw Material Analysis
· In Process Analysis
· Finished Goods Analysis
· Packaging Material Analysis
· Calibration and validation of Laboratory Instruments
· Fixation of Expiration Date (Stability test)
· Process Validation
· Product Complained analyses
· Investigation of Out of specification
· Environmental Analysis
· Development of New test Procedures
· GMP Audit
· New source approval
· Raw material validation
· Microbiological analysis
Quality assurance activity performs in the ORION Laboratories Ltd. Is given below a flow chart-
It is the part of good manufacturing practice, which is concerned with sampling, specification and testing as well as the organization and documentation and released procedures. It ensures the necessary and relevant tests that are necessary to determine whether the products will be released or not for use, the raw materials can be used or not until their quality has been judged to be satisfactory.
Quality Control Operations
The Q. C. department assures manufacturing of quality product. It is completely related with production operation, mainly done in the production area to check
- Dispensing of materials
- Checking in pharmacy weighing
- Compounding in ingredients
- Process validation
- In process checking
- Complains of G.M.P., mainly storage of raw materials, finished products.
- Label control
The objectives of quality assurance are achieved when processes have been defined which, when followed, will yield a product that complies with its specification & when the e finished product
- Contains the correct ingredients in the correct proportion.
- Has been correctly processed according to the defined procedures.
- Is of purity required.
- Is enclosed in its proper container, which bears the correct label or otherwise suitably marked or identified.
- Is stored, distributed and subsequently handled in such a way that its quality is maintained throughout its designated or expected life.
Various Tests done in QC
Quality control department performs 3 types of assay for analysis
· Chemical Assay
· Physical Assay
o For raw material
§ Solid raw material
o Bulk density
o Heavy metal testing
o Melting point
· Liquid raw material
o Refractive index
o Weight per ml
· For finished products
o Solid preparation
§ Dissolution and Disintegration time
§ Weight variation
· Liquid preparation
o Weight per ml
o Microbiological limit test
· Semisolid preparation
§ Microscopic examination
· For packaging material
o Weight (gm/m2)
o Visual inspection for defects
In the Quality control department all the information is written in a specific S.O.P. SHEET is prepared according to ORION Laboratories Ltd, Test procedure, BP and USP procedure. Several information, included, in the SHEET is as follows.
· Trade name and official name of the material
· Manufacturer date
· Lot No.
· Expiration date
· Label Potency
· Test Procedure (As described before)
· S.O.P. no.
Instruments in QC Department
In Quality control Department the following sophisticated instruments are used:
· High Performance Liquid Chromatography (HPLC): Agilent Technologies, Australia
· High Performance Liquid Chromatography (HPLC): Waters, Japan
· Refract meter
· Karl- Fischer Titrator: Miller
· UV visible spectrophotometer(1)
· UV visible spectrophotometer(2)
· Dissolution Tester
· Disintegration tester
· PH Meter
· Electronic PH Meter
· Melting point Testing Apparatus
· Hardness tester
· Fume Hood
· Electric Balance
· Vacuum Dryer
· Heating Oven
· Slide calipers
· Vacuum Pump Motor (for leak test)
· Humidity test chamber (for stability test)
· Muffle furnace system
· Graphite furnace system
· Water purification system
· Conductivity meter
· Magnetic Shaker
· Atomic absorption spectrophotometer
· Tap density tester(USP)
· IR detector
· Hydraulic press
Instruments used in Microbiology Laboratory
· Bacteria proof filter paper
· Vacuum Pump Motor
Tests in Microbiology lab
· Sterility test
· Microbiological contamination test
· Pyrogen test
· Growth promotion test
· Media validation test
· Solid media
· Liquid Media
o Environmental monitor
· SWAB test
· Settle plate technique
· Contact plate technique
· Air bone particle count
· Air sampling
High-performance liquid chromatography,(HPLC)
High-performance liquid chromatography, HPLC is a popular method of analysis because it is easy to learn and use and is not limited by the volatility or stability of the sample compound. The information that can be obtained includes identification, quantification, and resolution of a compound.
A liquid mobile phase is pumped under pressure through a stainless steel column containing particles of stationary phase with a diameter of 3-10 um. The analyze is loaded onto the head of the column via a loop valve and separation of a mixture occurs according to the relative lengths of time spent by its components in the stationary phase. It should be noted that all components in a mixture spend more or less the same time in the mobile phase in order to exit the column. Monitoring of the column effluent can be carried out with a variety of detectors.
- The combination of HPLC with monitoring by UV/visible detection provides an accurate, precise and robust method for quantitative analysis of pharmaceutical products and is the industry standard method for this purpose.
- Monitoring of the stability of pure drug substances and in drugs in formulations with quantization of any degradation products.
- Measurement of drugs and their metabolites in biological fluids.
- Determination of partition coefficients a pKa values of drugs and of drug protein binding.
- Easily controlled and precise sample introduction ensures quantitative precision.
- HPLC is the chromatographic technique, which has seen the most intensive development in recent years leading to improve columns, detectors and software control.
- The variety of columns and detectors means that the selectivity of the method can be readily adjusted.
Instruments used in Microbiology Laboratory
- Vacuum Pump Motor
Tests in Microbiology lab
- Sterility test
- Microbiological contamination test
- Pyrogen test
- Growth promotion test
- Media validation test
- Solid media
- Liquid media.
- SWAB test
- Settle plate technique
- Contact plate technique
- Air bone particle count
- Air sampling
In Process Quality Control
To assure batch-to-batch uniformity and integrity of the products, written procedures describing sample taking, the controls and tests or examinations is conducted on in process products of each batch should be established and followed. Such control is intended to monitor the product yield and validate the performance of the production process that may be responsible for causing variability in the characteristics of in process products.
The following in process quality control procedures are adopted
IPC for Manufacturing Section: –
|Tablet||Wt. Variation Friability Disintegration Dissolution Hardness Thickness|
SealingLiquidsBottle volumeSterile productsOver all supervision for all steps performed by the operators whether they complies or not with the SOPs.
IPC for Packaging Section
- The quality control/ quality assurance officer checks the packets
- The labels are checked by the officer to the standard labels
- The cartoons are checked randomly whether they contain specific no. Of packs or not.
- The blister and the sealing of the finished product are checked.
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 detective products.
To facilitate proper and effective use of documents these should be designed and prepared with care
- The title, nature and purpose of the document are to be clearly stated.
- The way of using the document and by whom should be clearly apparent from the document itself.
- Where documents bear instruction these should be written in the imperative. These should be clear, precise and in language so that the user can understand easily.
- Documents, which require the entry of data, should provide sufficient space for the entry.
- Reproduced documents should be cleared and legible.
RESEARCH AND DEVELOPMENT
R&D deals with some important functions:
- Pre formulation study
- Process validation-Prospective process validation, Retrospective process validation, Concurrent process validation, Revalidation
- Incompatibility study of active with excipients
- Trouble shooting &
- Packaging material specification
- Preparation of B.M.R. & B.M.R. for a new product.
- Evaluation & Development of existing product.
Development of a new product
Product information from marketing department along with .necessary attributes such as:
- Q.C test (potency. LOD etc)
- Pre-formulation study of the active drug and excision:
- Chemical activity
- Boiling point
- Moisture content etc.
Collection of raw material of active drug ingredients and excipients.
Different trials for development of a stable, effective and active Formulation.
Drug administration formalities include:
a) Submission of recipe to drugs administration which contains –
- Dosage form
- Dosage form
- -Side effe