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Showing posts with label report on Nuvista Pharma. Show all posts
Showing posts with label report on Nuvista Pharma. Show all posts

Wednesday, February 20, 2013

Report on Nuvista Pharma Ltd (Part-15)


WAREHOUSE

Ware House is the large area where all the raw materials, packaging materials and the finished products are stored. From the Ware House the raw materials are sent to the production unit. Again the finished products are stored in the Ware House.

Warehousing is normally the largest in terms of area special attention is paid which is focused on maintaining cleanliness freedom form infestation and order orderliness.
Different Units of Warehouse:
v    Storage for Raw material.
v    Storage for Packing material.
v    Storage for Finished product.
v    Storage for Thermolabile product (Foster/cold storage).
Areas of Warehouse:
1.    Quarantine area: After receiving, raw materials and packaging materials are kept here for QA approval. Area is located in the front portion of the building.
2.   Released area: Approved raw materials and packaging materials are generally stored in the central place of the warehouse with great safety.

3.  Rejected area: Rejected raw materials, packaging materials, finished products are stored             here with great care. The rejected area is located at corner portion of the warehouse in a       separate room, where entry is strictly regulated.
4.   Finished Products area: Finished products are stored here for delivery.
5.   Special area: It includes cold room, freeze room for poisonous materials, room for flammable materials.
Activities of Warehouse:
Warehouse activities can be stated as follows: (related to raw and packaging materials)
ü    Arrival of materials.
ü    Invoice checking.
ü    Physical inspection & receipt/discrepancy report.
ü    Quarantine storage.
ü    QA sampling.
ü    Leveling in the container.
ü    Entry in SAP.
ü    QA release/ rejected materials.
ü    Dispensing of released/ rejected materials.
ü    Dispensing / Distribution.

Objectives of proper receiving, issuing and storage of goods in Nuvista Pharma

Measures Target:

Ø  Proper entry of all receipts & issues into the computer / Kardex 100 %
Ø  Timely issue of goods to production department & central warehouse as per requisition. 100 %
Ø  To minimize handling loss of issuing materials
            Raw Materials NMT.500 %
            Packaging Materials NMT.500 %
            Finished Goods (Glass Bottles) NMT.500 %
Ø  Maintain FEFO (1st expelled 1st output) / FIFO (1st input 1st output) 100 %
Ø  Sometime maintain LIFO (last in first out) in case of raw material.
Ø  To follow guidelines as per cGMP / GSP 100 %
Ø   
Objectives of smooth receiving & supplying of packing materials, Raw materials (Solids, Liquids) in Nuvista Pharma -
Measures Target:

Ø  Timely unloading ½ hour after receiving the documents
Ø  Tallying the quantity with delivery challan against ½ hour after receiving purchase order / L / C & preparing G.R.N. the challan.
Ø  Orderly placement of received materials immediately after at quarantine area of the store receiving the materials
Ø Shelving passed materials at respective shelves quickly transferring of the packing materials store from quarantine.
Ø  Proper entry of all receipts & issues into the Bincard 100 %
Ø  Timely issue of packing materials to production department as per requisition. 100 %
Ø  To minimize handling loss of issuing materials
       Packaging 98 %
             Solid materials 99.5 %
             Liquids 99.5 %
Ø  Maintain FEFO (1st expelled 1st output) / FIFO (1st input 1st output) 100 %
Ø  To follow guidelines as per cGMP / GSP 95 %

Objectives of smooth receiving & supplying of finished goods in Nuvista Pharma:

Measures Target:

Ø  Tallying the goods mentioned in quickly after receive finished goods transfer note goods transfer note.
Ø  Proper entry of all receipts & issues into Cardex / Bincard 100 %
Ø  Timely delivery of goods as per prescribed vat challan & gate pass of custom authority 100 %
Ø  Preparing daily statement 100 %
Ø  Maintain FEFO (1st expelled 1st output) / FIFO (1st input 1st output) 100 %
Ø  To follow guidelines as per cGMP / GSP 95 %
Some common terms of Ware house:

Sampling

As the process of taking a small portion from a lot for test and analysis to show the quality of the whole lot. The purpose of sampling and subsequent testing is to provide an effective check on the quality of the product or substances being processed.

Sampling quantity

Sampling quantity should be the double of one complete test.
Lot
A batch or number of batches in a consignment.
Batch
A quantity of the product or material which is processed in one run following manufacturing USP. ]
Campaign
A campaign means number of batches manufactured without any interruption or product change.
Handling
The term handling means checking according to invoice/challan and other documents during receiving of the materials.
Preservation
The term preservation means the materials are stored in different conditions according to its nature of stability i.e. to maintain a specific temperature and relative humidity.
Dispensing
Dispensing means the materials are supplied to the production areas by weighing according to the proper document and release it from the RM Store.
Quarantine  The term quarantine means the material is not ready for use and it is under test after received. So a quarantine label is attached to the container.
FIFO The term FIFO stands for First In First Out.
Re-test The term re-test means the samples are needed to be repeated analysis for identify vs. previous documentation and it has been done either 3/6/12 months.

Report on Nuvista Pharma Ltd (Part-11)

PARENTERAL DEPARTMENT

Injections are sterile and pyrogen free products that intended to be administrated in the body with the help of syringe or needles through various route such as IV, IM etc. As the products directly go to the circulation, they must be free from any microbial contamination, toxic compound that should process & exceptionally high level of purity.
Nuvista Pharma has separate section for injections which consists several subunits-

  • Aseptic room for filling and sealing
  • Sterilization room (autoclaving and terminal sterilization)
Facility status for aseptic area:

  • Room temperature: 20ºC ± 2ºC.
  • Room humidity: 45% to 60%
  • Air velocity of laminar flow: Horizontal 84+20 ft/min, Vertical 56+10 ft/min.
  • Air change not less than 20 per hour.
Environmental cleanliness standard:
It is defined in term of maximum number air borne particle rather than a define particle size in a given volume of air -
Particle
British standard
U.S. Federal Standard

Class
No./ft3
No./m3
Class
No./ft3
No./m3

0.5 μ
1
86
3000
100
100
3500
5 μ
1
0
0
100
0
0
0.5 μ
2
8495
3,00,000
1000
1000
3,50,000
5 μ
2
57
2000
1000
65
23,000
Cleaning and sanitation for aseptic area:

  • Fumigation of the room: this is done with 2.5% savlon in DM water.
  • UV irradiation for whole night.
Sterilize products and equipments:

Type
Condition
Materials

Moist heat
sterilization

Autoclaving 121ºC at 15
Kg/cm2 for 30 minutes.

Finished products (Ampoule, vial),
Rubber closure, container, membrane filter, SS vat, filling machine.

Dry heat
sterilization

Heating at 220 ºC for 2 hours. (Double door)

Equipment, empty ampoules, vials, bottles etc.

Water treatment plant:-
In NUVISTA PHARMA water used in liquid division mean purified water, drinking water, normal water, distilled water, WFI (water for injection) all are supplied by sterile division.
Water filtrated by 0.2μ filter. In some cases specially water wastage in washing section in sterile division are reused by filtration and pass through IR. Drinking water also supply in the head office through container.


Fig: Water Treatment Plant Flow Chart of Nuvista pharma Ltd.


Equipment used in Sterile Manufacturin
          ROTA Filling & Sealing Machine for Ampoules, England
           Filtration Machine – Palltronic, Germany
           Manufacturing Vessel (50 Liter)
           Laminar Air Flow Unit, Franz Ziel, Germany.
           Hot Air Sterilizer
           Dissolved Oxygen Analyzer
           Distilled Water Plant
           Linden Autoclave (17) Steam Generator
Sterile section has terminal products and aseptic product producing zone
Terminal products:
The products which are not heat sensitive are called terminal products. The products are auto-claved after filing and sealing. Mainly injections and water for injections are terminal products
Aseptic products: 
The products that are heat sensitive are aseptic products. Autoclaved is done by filtration process. Double filter paper is used. The pore size of first filter paper is 0.5 mµ. The pore size of second filter paper is 0.2 mµ. no bacteria can pass through the pores of 0.2 mµ. Mainly eye drops and insulin are considered as aseptic products
Packaging department
Packaging is the process by which the pharmaceutical products are suitable paked, in such way that they should retain their therapeutic effectiveness from the time of their packaging to consume by the consumers & it also helps to withstand the stress during transport.

Nuvista Pharma Limited has a well-established packaging department.
   Packagings are of two types:

  • Primary packaging  (Direct contact with the product eg.alluminium foil)
  • Secondary packaging (No contact with the product eg. cartoon case etc)
Primary packaging has two categories:

  • Blister packaging
  • Strip packaging.
In Nuvista Pharma Blistering machine are:
Ø  HOONG A- Korea
Ø  HOONG B- Korea
Ø  HOONG C- Korea
Ø  FORMPACK ( Injection )
Ø  GANSON-India ( Tablet strip)
Ø   Batch Printing Machine:
Ø  Morico, Japan

Two forms of blistering:
Ø  Alu – alu
Ø  Alu – PVC

Material Used in Packing Section:


Ø     Alu.Foil(Blister/Strip)
Ø     PVC/PVDC Film
Ø     Alu-Alu Foil (Bottom).
Ø     Bottle/Alu.Tube.
Ø     PP Cap.
Ø     Label.
Ø     Unit Carton.
Ø     Insert.
Ø     Plastic Spoon.

Ø     Plastic Cap.

Ø     Stopper.
Ø     Shipping Carton.
Different parts of Blistering machine:

Ø  Heating device
Ø  Forming station
Ø  Filling station
Ø  Sealing station
Ø  Cooling station
Ø  Draw off
Ø  Production tray
Ø  Slit heater
Ø  Code embossing station
Ø  Cutting station
Ø  Coiler
Ø  Conveyor belt


Flow chart of how a Blister machine works during PVC-Aluminium Blister:  



1
2
3
4
5
6
7
8
9
10
Pre heater (110 °C)
Forming plate
(Air pressure used)

Hand loading of tab/cap.
Sealing (190 °C)
Cooler (to ensure the product is not exposed to heat)
Batch no.
Cooling
Slitting
Draw
Cut
Important for primary packaging:

Ø  Plug area create pocket by plugging (Alu-Alu), In case of Alu-PVC forming create pocket with the help of air pressure & temp (130º-160 ºC).
Ø  Tablets are manually arranged into production trey.

Ø  In-case of automatic filling, hopper chute channel has two parts
> Chute vibrator
> Feeding roller.
Ø  Top holders contain Aluminium foil.
Ø  Sealing temperature 150 ºC to 210 ºC.
Ø  Scoring is done by slitter. In case of alu-alu, no heat is required. Whereas in alu-PVC 80 ºC to 100 ºC temperature is required.
Ø  Waste coiler coil the wastage remaining after cutting.
Ø  Drawer draws the blistering materials to the cutting area.
The test that are performed by this section for packaging materials are-
Materials Name
Test specification
PVC
Color, width, thickness, weight per unit area etc.

Cotton
Appearance, weight, moisture.

Shipping carton
Weight, diameter, thickness.

Inner carton
Height and level description

Plastic cap
Appearance, weight, length, volume etc


Dropper
Appearance, length, weight and plastic cover.
Tape (adhesive)
Appearance, width, Adhesiveness.
Bottles, Ampoules
Height, volume, capacity, diameter, machine acceptance etc.

Test for Primary packaging:
Ø  Leak test
Ø  Primary quality
Ø  Batch No. and Exp. Date
Ø  Perforation
Ø  Sealing
Ø  Clarity of Pocket
Leak Test:
Leak test is done by the leak test machine after completing blistering and stripping.
Blister / strip are kept under the pored vehicle in the container which contains purified water. Air pressure is given by switching on. Maximum 760 mm Hg pressure can be given. But usually 400 mm Hg is given in case of big pocket and 600 mm Hg is given in small pocket.
Test for secondary Packaging:

Ø  Box, Leaflet, Strip

Ø  Batch No., Mfg. Date, Price

Ø  Color & printing of the Box
When the primary packaging is completed then the tablet or capsule containing blister or strips are checked. And finally the strips or blisters are made ready for secondary packaging.

A fixed number of tablets or capsules are packed into each strip or blister. And a fixed number of strips or blisters are packed into each packet. The packets are
then poured into the box.