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
| |||||
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.
