In Plant Training Report at Rangs Pharmaceuticals Ltd

INTRODUCTION

In Bangladesh the pharmaceutical sector is one of the most developed hi-tech sectors which are contributing in the country’s economy. After the promulgation of Drug Control Ordinance – 1982, the development of this sector was accelerated. The professional knowledge, thoughts and innovative ideas of the pharmacists working in this sector are the key factors for these developments. Due to recent development of this sector it is exporting medicines to global market including European market. This sector is also providing 97% of the total medicine requirement of the local market. Leading pharmaceutical companies are expanding their business with the aim to expand export market. Recently few new industries have been established with high tech equipments and professionals which will enhance the strength of this sector.

Rangs Pharmaceuticals Ltd is one of the leading Companies in Pharmaceuticals sector. After all necessary arrangements it launched its production on 2004 with 12 products which were mainly antibiotic and anti ulcerants. There after it did not look back. At present it manufactures 120 important products.

SOLID  DOSAGE  FORM  MANUFACTURING:

TABLET DEPARTMENT

Tablet:

Tablet manufacturing unit one of the most important unit in the production area of a pharmaceutical company. Tablet can be defined as a solid  pharmaceutical dosage form containing active  drug substances and excepients & prepared either by compression or molding method (according to NF). In Rangs pharmaceuticals Ltd, solid section is the biggest section of all. Solid section provides about 70% of the total turn over per year. By this way this unit plays a vital role in the financial aspects of the company.

Major steps of tablet manufacturing:

• Granulation
• Compression
• Coating

Tablet manufacturing area:

a. Dispensing area

b. Granulation area

c. Blending area

d. Compression area

e. Coating area

Dispensing Area:

Dispensing

Dispensing means to supply materials to the production area by proper weighing according to the relevant document and release it from the raw materials store.

Weighed raw materials from warehouse are also rechecked here.

Machine  for  Dispensing:

Electronic Balance

Granulation Area:

Granulation:

The process, by which the primary active ingredients and excepients powder particles are made to adhere to form larger multi particles, is called granulation.

Granules size range for pharmaceuticals: 0.2-4

Types of granulation:

1)    Wet granulation

2)    Dry granulation

3)    Direct compression

In Rangs Pharmaceutical only wet granulation and direct compression are done.

Purpose for granulation:

• To prevent segregation of the constituents of the powder mixture
• To improve the flow properties of the mixture
• To improve the compaction characteristics of the mixture

 Process of wet granulation

Raw material screening through the vibratory sifter

Mixing of active ingredients with excepients

 Wet mass

Pass through Grating & Shredding machine

Drying

 Sieving

Blending with lubricant

Machine:

1. Tablet mixing machine

   Rapid mixer granulator

   Model-RMG-400

   Capacity-120 kg

   Clit

   Origin-Germany

2. Multimiller

    Clit

    Origin-Germany

3. Fluidized bed dryer

    SOLACE AERO DRYER

    Capacity-120 kg

Blending Area

Blending:

Blending is the process of uniformly mixing the ingredients so that each tablet contains the unit amount of dosage.

Machine:

1. 1.    Double Cone blender

MARK

      Model-DCB-600

      Capacity-120 kg

      Origin-Bangladesh

Compression Area

Compression:

The process of forming tablets in desired shapes compressing by sufficient pressure.

Factors to be considered during compression:

  Temperature

  Relative humidity

Compression Machine:

200GMP-SQUARE MODEL

Model-CPM D3

Capacity-130000

Running capacity-50000

Clit

Origin-Germany

200GMP SQUARE MODEL

     Model-CPM B3B

     Capacity-130000

     Running capacity-78000

     Clit

     Origin-Germany

Coating Area

Coating: 

A layer of a substance spread on the surface of the core tablet. Sugar coating was popular in past but it has many drawbacks. Modern tablet coating is polymer and polysaccharide based, with plasticizers and pigments included.

Types of coating:

1. Film coating

         Organic solvent based

          Aquous solvent based

1. Sugar coating
2. Enteric coating

In Rangs pharmaceuticals only film and enteric coating is performed.

Steps of Film coating:-  

• § Solvent

——- Organic

——- Aquous

• § Polymer 
• § Plasticizer
• § Optional ingredients

                    — Anti-foam agent

                    — Colorant

Weight gain for different coating:

• Film coating            : 2-3%
• Enteric coating        :3.5-6%

Coating Machine:        

1. 1.    NR Cota 29” Film coating machine

                      Model-FC-29

                                   Capacity-20-30 kg

                                   Origin-England

1. 2.    NR Cota 39” Film coating machine

                      Model-FC-39

                      Capacity-120 kg

                      Origin-England

Tablet Preparations in Rangs Pharmaceutical-

 CAPSULE  MANUFACTURING  DEPARTMENT

ENCAPSULATION

According to the USP, “capsules are solid dosage forms in which the drug is enclosed in either a hard or soft, soluble container or “shell” of a suitable form of gelatin.”

Derived from the diminutive of the Latin word “capsa” meaning “box”, a capsule is literally “a little box” and can refer to any encompassing structure or small container.

Capsules are two types –

1. Hard gelatin capsule
2. Soft gelatin capsule

In Rangs Pharmaceuticals Hard gelatin capsules are   produced. In which, the active is failed an the empty hard gelatin capsule shell in form of

                        ·    Powder

                        ·    Pellets

In Rangs Pharma powder are encapsulated with the help of semi automatic feeling machine and liquid is encapsulated with automatic capsule filling machine.

Capsule Preparations in Rangs Pharmaceutics:

Brand Name                                 Dose

E-gold

Antif                                            250, 500mg

Curacid                                        20, 40mg

Droxil                                          500mg

Fungitrol                                     50, 150mg

Lindex                                         250, 500mg

Maxflo-U

Ngcef                                          200mg

Perpen                                         250,500

Prevencid                                    20,40mg

Pregmin

Pregmin-Z

Process of capsule manufacturing (powder):

Station having two parts upper plate and lower plate with negative air pressure collect shell from shell channel where cap remain at the top and body remain at the bottom.

• Upper plate contain cap and lower plate Contain body
• Lower plate goes feeding channel
• Body of capsule filled with Powder
• Both plates close to each other
• Finally at the end of Encapsulation operation shut down the machine
• Checking and polishing
• Packaging

In this section pellets are encapsulated with the help of semi automatic filling machine.

Process of capsule manufacturing (Pellets):

• Capsule shell in the hopper
• Shell channel

Station having two parts upper plate and lower plate with negative air pressure collect shell from shell channel where cap remain at the top and body remain at the bottom

• Upper plate contain cap and lower plate Contain body
• Lower plate goes feeding channel
• Body of capsule filled with pellets
• Both plates close to each other
• Finally at the end of Encapsulation operation shut down the machine
• Checking and polishing
• Packaging
• Machine

1. 1.    Cone blender

                                    MARK

                                          Model- DCB-406

                                          Capacity- 160kg/B

                                          Origin- Bangladesh

1. 2.    Semi automatic capsule filling machine

                                    P^+am

                                    Model- SA-9

                                    Capacity- 25000 capsule/Hr

                                    Origin- India

1. 3.    Polishing & Cleaning machine

                                    Hoonga- A Corporation

                                                      Origin- Korea

Problem may arise during encapsulation:

  Weight variation

  Capsule shell may be brittle when room condition is not maintained

 E- Gold

It is a new technology that Rangs Pharmaceuticals has incorporated to product Licap. Only 3 companies at this moment manufacturing this product. Rangs Pharmaceuticals is one of those. This product is also very effective.

E-Gold 200 Licap:

Each Liquid Filled Hard Gelatin Capsule contains Vitamin E

200 mg (as alpha-Tocopheryl Acetate BP).

Advantages over soft gelatin capsule:

• Improve Bioavailability
• Economic

Materials use for E-Gold preparation:

• Vitamin E (Alpha tocopheryl)
• Soyabean Oil
• BHT
• E.H.G Capsule Shell #1
• Gelatin
• Green Lake Color
• Tween 80
• Purified Water

Process of E-Gold production:

1.       I.    E-Solution preparation
2.     II.    Bending solution preparation

E-Solution is prepared by following process:

BHT is added in soybean oil in a beaker

                                                                        Heating

                                                                        Cooling

Adding this solution in vitamin E

                                                                         Filter

Banding solution preparation:

Banding solution is prepared by following process:

Gelatin is added in water

Take them 30 min

                                                                  Stirring

Tween 80 is added (30 min)

• Taken in water bath (40 min or 1 hour)
• Color is added
• Left them over 1 night at 50°C temperature

Process of E-Gold manufacturing:

E-Gold manufacturing is done by automatic capsule filling and banding machine.

The process is following:

Check the room condition

Obtain QA report for capsule filling

Use the right capsule shell #1

Adjust the machine

Start filling

Keep record of starting time and finishing time

Finally at the end of encapsulation operation shut down the machine

Transfer filled capsule to the bend sealing area pass through the automatic bend sealing machine

Checking and polishing

                                                                               Packaging

Problem may arise during E-Gold manufacturing:

  Bubble Formation

  Banana Effect

Machine

1. 1.     Automatic Capsule Filling Machine

                                                                       P^+am

                                                                                                      Model- LF-40

                                                                       Capacity- 40000/hr

                                                                       Origin- India

1. 2.   Automatic Capsule Bending & Sealing Machine

                                          P+am

                                                                       Model- BS-40

                                                                       Capacity- 40000/hr

                                                                           Origin- India

SOLID PACKAGING:

The terminal stage of the production is packaging. This is the terminal stage at which a finished product gets a shape for marketing purpose. Proper packaging maintains the integrity of the pharmaceuticals. It should preserves drug efficacy as well as its purity, identity, potency and quality for its entire shelf life. The selection of package therefore begins with the determination of the product’s physico-chemical properties, its protective needs and marketing requirements.

Packaging materials are of two types:

1. 1.  Primary packaging materials

• PVC
• Aluminum foil

1. 2.  Secondary packaging materials

• Printed box
• Leaflet
• Labels
• Outer
• Printed tape
• Liner

There are two types of packing:

1. 1.     Blister packing
2. 2.     Strip packing

Only Blister packing is done in this section.

Blister Packing: 

Usually tablets and most of the capsules is blister packed in this case, at first the PVC/PVDC /Aluminum foil is heated by heating plate. The packets are produced by the air pressure and immediately cooled. At the next stage tablets/capsules are filled into the pockets are pockets and the aluminum foil is sealed over the PVC/PVDC/ALU film by heating. Finally the blister pack cut into suitable size.

There are 3 types of Blister:

1. 1.    Alu-PVC blister
2. 2.    Alu-Alu blister
3. 3.    Alu-PVDC

Process of Packaging:

Blister forming

Tablet filling

Sealing the blister with printed alu- foll

Printing of batch no. & Exp. Date

Cutting into individual blister pack

Visual inspection

Packing

Warehouse after QA approval

Machine

1. 1.    Blister Packaging Machine

Hoonga

                                               Model- MINISTER-VAL

                                    Hoonga-A-Corporation

                                    Origin- Korea

1. 2.    Blister Packaging Machine

Hoonga

                                               Model- MINISTER-V

                                    Hoonga-A-Corporation

                                   Origin- Korea

1. 3.    Topical Blister Packager

Model- DPR-250

RUIAN JIANGHUA MACHINERY.CO. Ltd

Origin- China

LIQUID  MANUFACTURING  DEPARTMENT

Introduction

Liquid preparations are solution containing one or more chemical substances dissolved in a suitable solvent or mixture of muyually miscible solvent.

Liquid dosage form include

• § Syrap
• § Suspension
• § Emulsion
• § Paediatric Drops
• § Granules for suspension
• § Eye Drops

Liquid preparation in Rangs Pharmaceutical

Syrup

Syrups are concentrated aqueous preparations of a sugar substitute with or without flavoring agents and medicinal substances.

Syrups provide a pleasant means of administering a liquid form of a disagreeable- testing drug.

Main ingredients of Syrup

Without the water and active ingredient syrup contains the following ingredients…

• The Sugar, usually sucrose, or sugar substitute used for sweetness and viscosity.
• Antimicrobial Preservatives
• Flavoring agent
• Coloring agent

 STEPS OF SYRUP PREPARATION:

• Dispensing
•  Manufacturing
• Storage
• Test sample given to QC
• After QC passed the sample, start filling and sealing.
•  Packaging

Suspension:

Suspension is the process of preparing homogenous two phase system in which the internal or dispersed phase is solid and the external or continuous phase is liquid.

Steps of Preparation:

Carefully tare the container

Finely powder any ingredients not already in fine powder.

Mix the insoluble powder in a mortar

Adding first the ingredients of smallest bulk and diluting it with others increases order of bulk, using amount equal to the bulk already in the mortar.

Add enough vehicles to produce a smooth paste.

Add, in small amounts, any non volatile solid ingredients, dissolved in part of the vehicle, and mix well.

If necessary, dilute with the vehicle until pourable.

Examine the suspension critically.

Before use, rinse the fabric with a little vehicle to detouch loose fibers.

Strain into the tared bottle.

Add any volatile solid ingredients, previously dissolved in some of the vehicle, and mix well.

Add any liquid ingredients, rinse the measures and mix well after each edition.

Rinse the mortar and pestle with successive volumes of vehicle until they are quite clean, transferring the rinsing to the bottle.

Make up to volume with the vehicle and shake thoroughly.

Then the sample is given to the QC for test.

Filling and Sealing.

Packaging

Equipment used in Liquid Section in Rangs Pharmaceutical:

• Syrup Preparation Vessel
• Eulsifier-1
• Eulsifier-2
• Semi Auto Liquid Filling Machine
• Semi Auto Cap Sealing Machine-1
• Conveyer Table-1( Liquid )
• Bottle Washing Machine
• Bottle Dryer
• Colloid Mill
• Transfer Pump
• DM Plant
• Distilled Water Plant (120 L)
• Distilled Water Plant (40 L)
• Liquid Filtration Unit

Dry Syrup Section:

• Mechanical Sifter-2
• Double Cone Blander-2
• Semi Auto Powder Filling Machine
• Semi Auto Cap Sealing Machine-2

STERILE  PRODUCTS  MANUFACTURING

Parenteral products:

In Rangs Pharmaceuticals Parenteral products are prepared as sterile product. As Parenteral products are given directly to systemic circulation so sterility is a must.

Environmental conditions that are maintained in sterile product manufacturing:

Air:

The air of the sterile product manufacturing area should be strictly maintained. There are some air classifications for the manufacturing area to maintain CGMP. This are-

Air Classifications

 HVAC system:

HVAC is an acronym for ‘Heating ventilation and air conditioning’ system and is sometimes referred to as climate control. The system helps to control humidity and temperature of the air within a building and are responsible for maintaining pressure relationships between spaces, ensuring smoke control. HVAC system works, primarily to provide healthy and comfortable interior conditions and are well designed to perform the task with minimal energy consumption and air, water pollutant emissions.

Use of HVAC System

  Heating: Heating technology makes use of equipments such as a boilers, forced air gas furnace, heat pumps and radiant floor heat to heat the environment or interiors.

  Cooling: Cooling technology includes equipments such as central and room conditioning, chillers, desiccant dehumidifiers and absorption cooling for various buildings.

  Air ventilation and quality: This includes using equipments such as variable air volume systems (VAV), Low-pressure-drop ducting design, lowface-velocity air handlers etc for high efficiency air distribution system.

HEPA Filter:

A high efficiency particulate air or HEPAfilter is a type of high-efficiency air filter.

Function

HEPA filters can remove at least 99.97% of airborne particles 0.3 micrometers (µm) in diameter. Particles of this size are the most difficult to filter and are thus considered the most penetrating particle size (MPPS). Particles that are larger or smaller are filtered with even higher efficiency.

HEPA filters are composed of a mat of randomly arranged fibres. Key metrics affecting function are fibre density and diameter, and filter thickness. The air space between HEPA filter fibres is much greater than 0.3 μm. The common assumption that a HEPA filter acts like a sieve where particles smaller than the largest opening can pass through is incorrect. Just as for membrane filters, particles so large that they are as wide as the largest opening or distance between fibres cannot pass in between them at all. But HEPA filters are designed to target much smaller pollutants and particles are mainly trapped (they stick to a fibre) by one of the following three mechanisms:

Interception, where particles following a line of flow in the air stream come within one radius of a fibre and adhere to it.

1. Impaction, where larger particles are unable to avoid fibres by following the curving contours of the air stream and are forced to embed in one of them directly; this effect increases with diminishing fibre separation and higher air flow velocity.
2. Diffusion, an enhancing mechanism is a result of the collision with gas molecules by the smallest particles, especially those below 0.1 µm in diameter, which are thereby impeded and delayed in their path through the filter; this behaviour is similar to Brownian motion and raises the probability that a particle will be stopped by either of the two mechanisms above; it becomes dominant at lower air flow velocities.

Diffusion predominates below the 0.1 μm diameter particle size. Impaction and interception predominate above 0.4 μm. In between, near the 0.3 μm MPPS, diffusion and interception predominate.

Dehumidifier:

A dehumidifier reduces the level of humidity in the air, usually for health reasons, as humid air can cause mold and mildew to grow inside homes, which has various health risks. Relative humidity is preferably 30 to 50%. Very high humidity levels are also unpleasant for human beings, can cause condensation .

In pharmaceutical industry,dehumudifier is used o control the humidity of the manufacturing area.

A/C

Air conditioners automatically act as dehumidifiers when they chill the air and thus need to handle the accumulated water as well. Newer window units use the condensing coil and fan to evaporate the accumulated water into the outdoor air, while older units simply allow the water to drip outside. Central air conditioning units need to be connected to a drain.

Laminar air flow:

An airflow moving in a single direction and in parallel layers at constant velocity from the beginning to the end of a straight line vector.

In Rangs Pharmaceuticals, the filling and sealing of  the injectables are done under the laminar air flow to control contamination.

One way entry & exit:

One way entry & exit should be maintained. Because there is a possibility of the product to be contaminated. The products are passed via the passbox from one room to another room. This is also very important to maintain the sterility of the product.

Areas of Injectables:

• 1^st change room
• 2^nd washing room
• Final dressing room
• Air shower
• Material washing area
• Liquid processing unit
• Ampoule filling & sealing unit
• Air lock pass box
• Terminal sterilization

Process maintained in sterile product manufacturing unit:

• In the previous day of manufacturing, the packaging matrialals are collected and sterilized by-

                                 Dry heat sterilization

                                 Moist heat sterilization

                                 Bun washing machine

• To make pyrogen free of certain products, 250^o c temperature is maintained for about 90 minutes.
• In moist heat sterilization, 121^o c is mainained for 20-25 minutes.
• The production area is cleaned time to time by isopropyl alcohol.
• In the previous day of manufacturing, fumigation is done by 50% water and 50% formaldehyde
• The UV ray is passed over the night-before manufacturing.
• About 45% humidity and 25^o c temperature is maintained in the vial filling room.
• After filling and sealing, the products are transformed into intermediate store area.
• Blister packaging is done in the Rangs pharmaceuticals for injectables.

Sterile products of Rangs Pharmaceuticals

Product                                  Pack size

Lindex- 1g         IV/IM………….…….…1’s

Lindex- 500mg IV/IM…………….……5’s

Maxbac 250mg IV/IM………….………1’s

Maxbac 500mg IV/IM…………….……1’s

Maxbac 1g         IV/IM ………….………1’s

Oryx 250mg       IV…………….………..1’s

Oryx 500mg       IV …………….……….1’s

Oryx 1g              IV ………….…….…….5’s

Oryx 250mg       IM……………..……….1’s

Oryx 500mg       IM ………….…………1’s

Oryx 1g              IM ……………………. 1’s

Oryx 2g              IV ……………….…….1’s

Recofast 750   IV/IM ……………….……1’s

Kenodol-30 injection ………….………..6’s

Orafen Plus injection ………………..2X5’s

QUALITY ASSURANCE

ADMINISTRATION ORGANOGRAM:

•  Director
• Manager, QA & QC
• Asst. Manager, QA
• Senior Officer
•  Officer

Quality Assurance:

Quality Assurance is a wide-ranging concept, which covers all matters that individually and or collectively influence the quality of a product.

The impact of total quality maintenance is –

• Improved operating procedure
• Greater customer satisfaction
• Increased financial performance

Purpose:

GMP is that of quality assurance which ensures that, products are consistently producer and controlled to the quality stander appropriate to their intended use and as required by marketing authorization. A product specification this makes it clear that QA in the Generic, wider term.

The function of Q.A. in different section of the industry:

1. Ware House:

1. Receiving raw material & packaging material only by visual inspection
2. Attachment of Quarantine & sampled tag by proper sampling rule
3. Sampling rule : If the no. of pack is within 24 than no. of sampled   = ÖN +1
4. Sampling for :

–       Assay

–       Microbial test

–       Retention sample

5. Released or rejection of raw materials & packaging materials

2. Production Area:

In liquid —-

  Only the physical inspection of

  Cleanliness

  Maintenance of BPR in production

  Packaging

In solid —–

  Cleanliness of the area instrument by Physical inspection.

  In process QA checked :

  Hardness

  Thickness

  Weight variation

3. Packaging Area:

During packaging QA checked:

  Humidity of the packaging area

  Leak test (in case of bottle tilling)

  Appearance of tablet & cap

  Labeling of stripper & inner & outer cartoon.

QUALITY CONTROL

Quality Control

The regulatory process, through which industry measures actual quality performance, compares it with standards and acts on the difference.

Q.C. activities

Quality control is responsible for the day by day control of quality within a company. This department is stuffed with scientist and technicians who assess and assure that entire production process has been completed satisfactorily and satisfied all the aspects of GMP.

Protocol for quality control assignment

Sampling

                                    (A quality assurance officer

                                     does it & brings it to the Q.C department )

Supervising

(A representative from the Q.C. dept.

receives the sample & assign someone to analyze.)

Analysis

 (The analyst analyses the sample

 according to the specification)

Checking

  (After the tests, the results are checked)

Final approval

 (The Q.C. manager verifies the result)

Collection

(Q.A. officer collects the results

of the sample that was assigned

 previously. )

Instrumentation of Q.C. Department:

1. HPLC (high performance liquid chromatography)          

—This is used for product identification & assay.

Machine:  1. Shimadzu.

2. IR spectrophotometer

—This is used for product identification. It acts as a comparison with the  standard & the sample.

Machine :  1. Shimadzu ( IR Prestige-21 ).

3. UV-Visible spectrophotometer

—This is used for product identification .It concomitantly read the absorbances of standard & sample preparations.

Machine :  1. Shimadzu ( UV-1650PC ).

4. Karl-Fischer titrator

-It determines the water content of the sample.

Machine :  Schott(Germany)Titroline KF

5. pH meter

-It is used to determine the pH value.

Machine :  HANNA Instrument.

6. M.P.apparatus.

—It determines the melting point of the sample.

Machine :  1. Gallenkamp (England).

7. USP dissolution test apparatus

—It tests the solubility of the tab in definite medium, which gives the idea of the absorbing  of the tablet by human body.

Machine :  Electrolab (TDT-08L).

8.  USP disintigration test appartatus

-It tests the separation of the particle of sample in a definite medium.

Machine : Electrolab (ED2L).

9. Chemical Balance ( Sartorious).

10.Drying oven ( Memmert ).

11. Microscope

12. Hot Plate ( Nova )

13. Centrifuger ( Centrifuge-800 )

14. Oven ( Memmert )

15. Vortex mixer (VM-2000)

16. Humidity Control Chamber ( Shel lab, USA )

17.Water Bath (Memmert)

18.Leak Test Apparatus.

Apparatus for MICROBIAL TESTS

• Autoclave ( Tomin, Taiwan )

• Incubator. { Memmert ( 30-90ºc)

• Machine for laminar flow ( Air Tech)

• Oven

• Air Sampler (Sartorius)

• Air Borne Particle Counter (Climet)

• Sterility Test Apparatus.

MICROBIOLOGY  DEPARTMENT:

Involvement of Microbiology in major areas:

• Quality Control laboratory
• Quality Compliance ensuring GMP
• Quality Assurance of sterile products
• Method development as Apart of Product development
• Cleaning validation

TESTS  DONE  BY  MICROBIOLOGY  DEPARTMENT

Sterile Product Testing:

• Sterility test
• Bacterial Endotoxin test
• Microbiological immersion studies
• Microorganism identification

Non-sterile Product testing:

• Microbial limit test
• Microbial identification
• Antimicrobial Bioassay of Antibiotic
• Antimicrobial preservative effectiveness test
• Bioburden studies

Environmental monitoring:

• Air particulate count
• Air micro flora count
• Settle plate technique
• Swab test

Facility Validation Support:

• Cleaning validation
• Process water testing
• Test validation
• Process validation
• Instrument calibration
• Environmental monitoring
• Consulting

Common Tests are done in Rangs pharmaceuticals:

1. 1.    Sterility test
   1. 2.     Sterility test for WFI:
   2. 3.     Bacterial endotoxin test (LAL test)
   3. 4.    Total viable count test
   4. 5.    Fungal count
   5. 6.    Escherichia coli identification test
   6. 7.    Staphylococcas aureus identification test
   7. 8.    Salmonella sp.identification test
   8. 9.    Pseudomonas aeruginosa identification test

10. Settle plate

11. Air microflora count:

12. Swab test
13. Preservative efficacy test

Machineries:

1. 1.    Bacterial incubator

Memmert

Capacity: 53 liter

Temperature: 30° to 70° C

Origin- Germany

Function- Enhancement of Bacterial growth

1. 2.    Fungal incubator

Memmert

Capacity: 53 liter

Temperature: 30° to 70° C

Origin- Germany

Function- Enhancement of Fungal growth

1. 3.    Incubator

Memmert

Capacity: 53 liter

Temperature: 30° to 70° C

Origin- Germany

Function- Used for particular microbiological test

1. 4.    Speedy Autoclave

High Pressure Steam Sterilizer

Tomen

Temperature: 121° C, Time- 50min

Origin- Taiwan

Function- To sterilize media or materials

1. 5.    Laminar Airflow Cabinet

Airtech Horizontal type

Origin- Singapore

Function- To conduct microbiological in sterile environment

1. 6.    Air Microflora Sampler

Sanitization machine

Sertorius

Model- MD8

Origin- Germany

1. 7.    Air Borne Particle Counter

Climate

Model- CIT

Origin- USA

Function- Counting of different size of particles suspended into clean

room air

1. 8.    Refrigerator

Meiling Stone

Temperature: Below 8° C

Origin- Korea

Function- Preservation of microbial cultured kits

Research & Development Department

Functions of Research and development department:

  New product formulation.

  Reformulation.

  Reprocess.

  Trouble shooting.

  Preparation of B.P.R. for a new product.

  Development of existing product.

Development of a new product

Step-1:

Product information from marketing department along with necessary attributes  such as

– Source

– Sample

– Q.C test (potency. LOD etc)

Step-2:

Pre-formulation study of the active drug and excipient.

– Chemical activity.

– Function.

– Interaction.

– Boiling point.

– Contraindication.

– Moisture content etc.

Step-3:

Collection of raw materials of active drug and excipients.

Step-4:

Different trials for development of a stable, effective and active formulation.

Step-5:

Drug administration formalities include:

a) Submission of recipe to drugs administration which contains –

– strength

– dosage form

– contraindication

– dosage form

– dissolution

– description

– precaution

– side effect

– M.R.P.

– indication

b) Sample admission (if INN product)

c) Approval of sample from drug administration and inclusion of D.A.R. and license

    no.

d) Submission of Inclusion Dossier.

e) Final approval for commercial production.

Step-6:

Pilot trial and accelerated stability testing.

Step-7:

Readjustment If necessary.

Step-8:

BMR preparation if every aspect is satisfied which contains

– product name

– code

– size

– batch no

– theoretical yield

– batch size

– annexure etc.

Step-9:

Transfer to commercial production.

Development of existing products

Research and development department also deals with the development of existing product formulation.

Objective:

a) Increasing the quality of the product.

b) Prevention of any type of problem existing in the product.

c) To save time and cost.

d) Increasing the patient acceptance.

The project file       

It contains project related every papers such as

• Recipe
• Product attributes
• Lab tried process records
• Stability study protocol and report
• Approved product data sheet
• Sales forecast
• Standard packaging material sample
• Process validation protocol record
• Related correspondence

WARE HOUSE DEPARTMENT

Involved areas

–       Raw material store

–       Packaging material store

–       Finished product store

Conditions maintained in ware house:

• For non antibiotic store, normal temperature and storage condition is maintained.
• For antibiotic store, 15-18^oc and bellow 50% humidity is maintained.
• For cool sore, 2-8^oc temperature is maintained.

GMP method for Ware house:

FIFO (first in first out) strategy is followed for the release of RM to manufacturing. Although materials are always taken from the approved source, batch no of the renders, manufacturing date, expiry date, etc are checked before entry, complete security & prevention of pilferage of every materials are confirmed.

Activities of Ware house:

1. Initially in the ware house, the quality of the product is not checked.
2. Only physical exam is done, which include whether he container is properly sealed.
3. If he staffs mentioned in the invoice are present or not, if the no. of the container are   same or not.
4. If passes kept in quarantine area
5. The invoice date of he received is inputted in SAP
6. From SAP, QC check if every thing is ok and a manual is also sent o QC
7. From sampling booth the sample is sent o QC
8. Sample tag is attached.
9. If the RM complies, approval tag is attached by QC.
10. All the data are uploaded in SAP.
11. From there production we can see and ask according to need.
12. Ware house follows FIFO and doss the dispensing in the dispensing unit

MAINTENANCE

The function of this section is to separate the utilities and services in the plant. This section is very important for any pharmaceuticals. The utilities and services handled by this section are given bellow:

1. Electricity
2. Production machineries maintenance
3. Quality control machineries maintenance.
4. Utility services
5. Construction

CONCLUSION:  

Industrial plant plays a vital role in any industry. Quality product ensures the company’s prospect in order to create loyalty. Rangs Pharmaceuticals is no longer beyond the objective to provide quality product for the target customer. In order to gain the multi national infrastructure, Rangs Pharmaceuticals need to look forward in both in Plant Infrastructure and its proper management.