FORM 2
THE PATENT ACT, 1970
(39 OF 1970)
AND
THE PATENTS RULES, 2003
PROVISIONAL/COMPLETE SPECIFICATION
(See section 10; rule 13)
TITLE OF THE INVENTION : High Efficiency Rubber Bungs
APPLICANT(S) —— - _____
(a) Name: Mr. Vipul R. Bhagat
(b) Nationality: Indian
(c) Address: 6-B, Mount Blanc Chs., 6th Floor, 550 Jam-E-Hamshed, Matunga (E), Mumbai-400 019, India
APPLICANT (S)
(d) Name: Mr. Iyer Natrajan S.
(e) Nationality: Indian
(f) Address: 403 Kaveri, K. Raheja Residential Complex. Balkum Pipe Road, Thane(W)-400 008, India
PREAMBLE TO THE DESCRIPTION


PROVISIONAL
The following specification describes the
invention.
See Annexure 1 as attached
COMPLETE
The following specification
particularly describes the invention
and the manner in which it is to be
performed. :
NA
DESCRIPTION (Description shall start from next page)
See the Annexure I
CLAIMS (not applicable for provisional specification. Claims should start with the preamble - "I/We claim" on separate page)
See the Annexure I
DATE AND SIGNATURE (to be given at the end of last page of specification)
See the Annexure 1
ABSTRACT OF THE INVENTION (to be givenalong with complete specification on separate page)
See the attachment Annexure II

Note-
* Repeat boxes in .case of more than one entry
* To be signed by the applicant(S) or by authorized registered patent agent.
* Name of the applicant should be given in full, family name in the beginning.
* Complete address of the applicant should be given stating the postal index no./ code State ad country. Strike out the column which is/are not applicable.


VHB Pharmaceutical Pvt. Ltd.
Title of the Invention : High Efficiency Rubber Bungs
Annexure I Abstract:
"High Efficiency Rubber Bungs" can reduce the Freeze-drying time by approximately 10% this comment has all the advantage which is not available in the conventional stoppers. The material of construction will be same as the earlier material of construction.
Short Description :
Definition of Lyophilization :
Lyophilization is the drying process, which is used to remove water from heat sensitive products, usually for the purpose of preservation.
By removing water, the product becomes more stable at room temperature. This is a common process in the pharmaceutical industry because Lyophilization offers the advantage of drying at low temperature and producing very low residual moisture contents.
In the Lyophilization the product filled in the form of liquid. During the process of bunging, the bungs are not fully closed. This is known as half bunging. Then the vials are loaded in the drying chamber. Here the phase transfer from solid to vapor takes place. The vapor passes through the windows of the bungs as shown in fig.
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t- thickness

Fig. This plugs shown with 3 windows (but for calculation purpose we have taken two windows.)
In this paper we will mathematically arrived, what should be ideal position of bung so that drying takes place at optimum efficiency.
If vial opening given as 0 D mm. The total vapor will be coming out through this window,
IT D2mm
The thickness of bung is t mm, which is inserted in vial, and bungs are having two windows, as shown in fig.
Window
For calculation purpose, take thickness t mm. The area which is occupied by bung, will be

II_D2--rIID-2t) 2 eqn 1
4 4
= II [D2- (D~2t)2] 4
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This is entire area of

This is divided into two windows. The thickness is not covering total area. It covers only half the circumference.

Free area available for the vapor to go will be,

After simplification we will get,

The vapor will escape through the window of bung. Suppose 'w' is the width, T is the length, and then the area will be 'wl' mm .
The area of two windows is 2wl. This area should be equal to or bigger than the equation 3.

2 (w x I) >J1_(D^ - 2 t D + 2 t2) 4
w 1 >jn_(D2-2 t D + 2 t2)
8
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As the window width is constant, w = constant, only length can be vary.
1 > [_n_ (D2 - 2 t D + 2 t 2) ] mm
8 w
The length has to be calculated from top of window. The bung has to insert up to the mark.
This will give uniform drying and sample will be the representation of entire batch.
A Iyopholized products normally are filled in liquid state and contains 70-90% of water. These water molecules are removed by using vacuum and freezing it below the eutectic temperature or collapse temperature. Thereby water molecules are separated from the product. This process is used wherever product is thermally sensitive, (where water cannot be removed by heating) one of the major advantage of lyophilisation is that it removes water from the cavities of the product, without any change in the physical properties it. Also lyophilisation is used where product is not stable in solutions, like hormones and some anticancer drugs.
In the above mentioned fig. you will clearly see that before removing the water and after removing the water the physical structure is maintained.
Lyophilisation is used'in injectables. First the liquid is filled and it is half bunged.(half is not right word it is closed to certain distance). And the remaining portion is kept open and in this open condition
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many vials are loaded into the lyophiliser self. When a lyophilisation takes place the water molecules from the product escapes- through the cavity provided in the bung. These cavities are designed to provide the open space in such a fashion that the vapour, which is generated, goes unhindered to the condenser when vacuum is applied.
By changing geometries of the stopper the vapors, which are leaving the surface, can be enhanced thereby the time requirement for lyopholisation can be reduced by 10-20%. The opening in the stopper will be made in the form of ventury. Thereby when the vapors are flowing out there is a low pressure that is created in the throat of the venture. This low pressure will create additional velocity for pulling the water molecules. The conventional stoppers are having openings in the form of rectangles. The main disadvantage is sharp corners. Due to these sharp corners the vapor extraction is hampered. By using the modified lyophiliser stopper the sharp corners are avoided and the vapor extraction is enhanced.
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Theoretical ventury calculation: A ventury tube is used to measure the flow speed of a fluid in a tube. It consists of a contriction or a throat in the tube. As the fluid passes through the constriction, its speed increases in accordance with the equation of continuity. The pressure thus decreases as required by Bernoullis's equation.

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Claim :
1. New type of stopper increases the efficiency by reducing the freeze changing time by approximately 10% keeping all the other parameters constant. Compare to conventional extractor.
2. Shape corners are avoided thereby particle sheding is eliminated due to sharp corners, which are present earlier.
3. Stress is reduced & better stability is achieved.