Description:FORM 2

THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENT RULES, 2003

COMPLETE SPECIFICATION
(See Section 10 and Rule 13)

Title of invention:
A PROCESS FOR STERILIZING AND DE-HUMIDIFYING A SYSTEM

APPLICANT:
PRAJ HIPURITY SYSTEMS LTD.
An Indian company having address as:
Unit 1604, DLH Park, S.V Road, Near MTNL Signal, Goregaon (W),
Mumbai, Maharashtra, India - 400 104

The following specification particularly describes the invention and the manner in which it is to be performed.

CROSS-REFERENCE TO RELATED APPLICATIONS AND PRIORITY
The present application does not claim priority from any other patent application.
TECHNICAL FIELD
The present subject matter, in general, relates to the field of sterilization technology. More particularly, the present subject matter relates to a process for sterilizing and de-humidifying a system.
BACKGROUND
Sterilization plays a critical role in curbing risks involved in pharmaceutical processing and guaranteeing aseptic, and contamination-free environment in a system. Large scale manufacturing systems encompass numerous production lines comprising enormous vessels interconnected through multiple system pipes, that require complete sterilization to ensure the production of large quantity and highest quality product. Various circumstances such as, survival of the contaminants in the culture media, propagation of contaminants within the dead spaces of the system, irregularly sterilized system components, incomplete cleaning of system pipes, unoptimized sterilization between uses of the system, etc. can lead to contamination of a processing system, leading to the formation of undesirable products as well as rendering the whole batch unusable. It is therefore established to incorporate sterilization as an operational step between uses to ensure that the pharmaceuticals and biopharmaceuticals manufactured through these systems fulfil the required production standards and are safe to use.
Although steam sterilization is known to be the most common and the most effective for its ability to kill microorganisms by reducing the time and temperature required to denature or coagulate proteins in the microorganisms, it is also known to generate condensate, in the form of excess water/moisture, which is retained within the crevices of the system pipes, production lines, and/or vessels of the system after exposing it to saturated steam under pressure.
Pharmaceutical products are fundamentally assigned a shelf-life which determines the time when a product is considered to be safe and effective under a relevant storage condition. A number of factors including chemical stability of the active pharmaceutical ingredient (API) in its dosage form are used to define it. It is largely known that moisture content, as a parameter, can adversely impact the physical properties of a pharmaceutical product, which in turn affects its chemical reactivity and binding properties, thus hampering its shelf life. In addition to this, pharmaceutical products may contain compounds that are harmful and that may require or not require moisture content to crystallize or agglomerate during manufacturing to render them useful.
Moisture content is therefore decisive for determining the safety, shelf-life, as well as the usability of a pharmaceutical product.
Processing of hydrophobic pharmaceutical products, which are fundamentally known to implement hydrophobic components such as mineral oil, organic solvents, and other such additives requisite moisture-free environment. The presence of moisture content in the form of condensate within the system after steam sterilization can therefore severely hamper the processing of these products and render them unsafe for application.
Previously, compressed air has been implemented as an operational step post sterilization to remove the condensate from the system. However, it was observed that this operational step not only compromised the sterility of the system, but also prolonged the time taken to de-humidify the system; thereby impacting the cost of pharmaceutical processing in terms of time as well as safety.
There is therefore a requirement for devising a process that can perform both sterilization as well as de-humidification of a large-scale system, especially in the pharmaceutical processing industry that is widely engaged in manufacturing hydrophobic pharmaceuticals, to achieve maximum efficiency, effectiveness, and quality. In addition to this, to optimize the processing of these products on an industrial scale, there is also a requirement for devising an arrangement that can achieve the said objectives absolutely/conclusively.
In pursuance of this, the inventors of the instant disclosure have standardized a sterilizing and de-humidifying process, as well as an arrangement thereof, to achieve an aseptic performing system, which also demonstrates zero-water retention post sterilization.

SUMMARY
An exemplary embodiment of the present disclosure relates to a process for sterilizing and de-humidifying a system, characterized in that, said process comprising, sterilizing supply assembly; sterilizing the system; and pressurizing and de-pressurizing the system with moving hot sterile air, while maintaining said system at 80⁰C to 90⁰C.
Another exemplary embodiment of the present disclosure relates to an arrangement to sterilize and de-humidify a system, characterized in that, said arrangement comprises, supply assembly configured to charge the supply assembly and/or the system with at least one of steam and moving hot sterile air; wherein, said steam carries out sterilization of at least one of the supply assembly and the system; and said moving hot sterile air carries out pressurization and de-pressurization of the system, while maintaining said system at 80⁰C to 90⁰C; valves configured to direct flow of at least one of said steam and said moving hot sterile air; and sensors configured to monitor process parameters.
This summary is not intended to identify all the essential features of the claimed subject matter, nor is it intended to be used in determining or limiting the scope of the claimed subject matter.
BRIEF DESCRIPTION OF DRAWINGS
The detailed description of drawings is outlined with reference to the accompanying figures.
In the figures, the left-most digit (s) of a reference number identifies the Figure in which the reference number first appears. The same numbers are used throughout the drawings to refer to the features and components.
Fig. 1 is a schematic representation of the instant disclosure demonstrating a manual air pressure regulator (01), isolation valves (02, 07, 08), an air filter (03), a heat exchanger (04), drain valve (09), an air header pipe (11), connector valve (12), steam entry valve (13), a steam entry pipe (14), a steam entry valve for vessel (15), a spray ball header (16), an isolation valve for spray ball (17), an air supply valve (19), a flush bottom valve (21), a product isolation valve (22), a sterile isolation valve of vessel (23), a condensate drain valve (24), a drain valve of vessel (26), a filter housing drain valve (28), a steam supply valve to harvest assembly (30), a steam isolation valve of harvest assembly (31), a product isolation valve of harvest assembly (32), a product isolation valve at receiving vessel (34), a boundary valve at receiving vessel (35), a drain valve from product transfer assembly (36), pressure transmitters (05, 18, 33), temperature sensors (06, 10, 25, 29, 37), an air inlet / exhaust filter (27), and an exhaust valve (20).
DETAILED DESCRIPTION
Reference throughout the specification to “various embodiments,” “some embodiments,” “one embodiment,” “alternate embodiment”, or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in various embodiments,” “in some embodiments,” “in one embodiment,” or “in an embodiment”, “in an alternate embodiment”, or “in a related embodiment” in places throughout the specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner in one or more embodiments.
Reference throughout the specification to “components”, “component”, “features”, or “feature” means a constituent or group of constituents embodying the process.
Before the present process is described, it is to be understood that this disclosure is not limited to the particular process as described, as there can be multiple possible embodiments which are not expressly illustrated in the present disclosure but may still be practicable within the scope of the present disclosure.
Also, the technical solutions offered by the present disclosure are clearly and completely described below. Examples in which specific conditions may not have been specified, have been conducted under conventional conditions or in a manner recommended by the manufacturer.
The instant disclosure relates to sterilization technology; and particularly describes a process for sterilizing and de-humidifying a system, and an apparatus thereof.
First aspect of the present disclosure relates to a process for sterilizing and de-humidifying a system, characterized in that, said process comprising, sterilizing supply assembly; sterilizing the system; and pressurizing and de-pressurizing the system with moving hot sterile air, while maintaining said system at 80⁰C to 90⁰C.
For the purpose of the instant disclosure and as is conventionally perceivable to a person skilled in the art, the terms “sterilizing”, OR “sterilization” relate to a process of complete elimination or destruction of all forms of microbial life and/or contamination. Further, the terms “de-humidifying” or “de-humidification” relate to a process of removing moisture/water/condensate, and/or ensuring zero-water retention. In addition to this, the terms “pressurizing” or “pressurized” relate to producing or maintaining raised pressure. Moreover, the terms “de-pressurizing” or “de-pressurized” relate to the process of lowering/ removing the pressure.
An embodiment of the present disclosure relates to a process for sterilizing and de-humidifying a system; said process comprising, sterilizing supply assembly.
For the purpose of the instant disclosure and as perceivable to a person skilled in the art, the term “system” encompasses set/sets of relative components described herein.
In an embodiment, the system comprises at least one of supply assembly, valves, and sensors.
In a further embodiment, the system comprises at least one of vessel and system pipe; and preferably, one or more of vessel and system pipe.

In an exemplary embodiment, the system comprises a manual air pressure regulator (01), isolation valves (02, 07, 08), an air filter (03), a heat exchanger (04), drain valve (09), an air header pipe (11), connector valve (12), steam entry valve (13), a steam entry pipe (14), a steam entry valve for vessel (15), a spray ball header (16), an isolation valve for spray ball (17), an air supply valve (19), a flush bottom valve (21), a product isolation valve (22), a sterile isolation valve of vessel (23), a condensate drain valve (24), a drain valve of vessel (26), a filter housing drain valve (28), a steam supply valve to harvest assembly (30), a steam isolation valve of harvest assembly (31), a product isolation valve of harvest assembly (32), a product isolation valve at receiving vessel (34), a boundary valve at receiving vessel (35), a drain valve from product transfer assembly (36), pressure transmitters (05, 18, 33), temperature sensors (06, 10, 25, 29, 37), an air inlet/ exhaust filter (27), and an exhaust valve (20).

For the purpose of the instant disclosure and as is perceivable to a person skilled in the art, the term “supply assembly” relates to an arrangement/assembly that encompasses set/sets of relative components that are involved in supplying at least one of steam, air, and/or gases. Further, the term “harvest assembly” pertains to an arrangement/assembly that encompasses processing related to any harvest, as is perceivable to a skilled person.
In an embodiment, the supply assembly is configured to charge the supply assembly and/or the system with at least one of steam, air, and/or gases; and preferably, at least one of steam and air.
In a related embodiment, the supply assembly is configured to charge the supply assembly and/or the system with steam, and air.
In an alternate embodiment, the supply assembly comprises a steam supply assembly; preferably, configured to charge the supply assembly and/or the system with steam.
In yet another alternate embodiment, the supply assembly comprises an air supply assembly; preferably, configured to charge the supply assembly and/or the system with air.

In a preferred embodiment, the steam is a pure steam.
For the purpose of the instant disclosure and as is perceivable to a person skilled in the art, the term “pure steam”, also known as “clean steam”, relates to saturated steam produced from additive-free water, free from non-condensable gases.

In yet another preferred embodiment, the air is sterile air.
For the purpose of the instant disclosure and as is perceivable to a person skilled in the art, the term “sterile air” relates to an air free from all forms of microbial life and/or contamination.
In a related embodiment, the sterile air is heated; particularly using a conventionally known heat exchanger.
In yet another related embodiment, the sterile air is moving.
In a preferred embodiment, the air is a moving hot sterile air.

A further embodiment of the instant disclosure relates to a supply assembly configured to charge the supply assembly and/or the system with at least one of steam and moving hot sterile air.

In a preferred embodiment, the supply assembly comprises at least one or more of supply valve, pressure regulator, isolation valve, air filter, heat exchanger, drain valve, header pipe valve, connector valve, entry pipe valve, header valve, header drain valve, and header pressure gauge.
In an exemplary embodiment of the instant disclosure, the supply assembly comprises a manual air pressure regulator (01), isolation valves (02, 07, 08), an air filter (03), a heat exchanger (04), drain valve (09), an air header pipe (11), connector valve (12), steam entry valve (13), and a steam entry pipe (14).

In one embodiment of the instant disclosure, the sterilization of the supply assembly is carried out by, charging the supply assembly with steam at ≥ 100⁰C; and preferably, at ≥ 121⁰C.
A related embodiment relates to holding the steam in the supply assembly for a pre-determined time; preferably for about 0.5 h.
In a preferred embodiment, the supply assembly is maintained at about ≥ 121⁰C.
For the purpose of instant disclosure, the term “about” pertains to ± 10 units.

Another embodiment of the present disclosure relates to a process for sterilizing and de-humidifying a system; said process comprising, sterilizing the system, as described above.
In one embodiment of the instant disclosure, the sterilization of the system is carried out by, charging the supply assembly with steam at ≥ 100⁰C; and preferably, at ≥ 121⁰C.
A related embodiment relates to holding the steam in the system at a pre-determined pressure; preferably, at about 1.2 bar (g).
A further related embodiment relates to holding the steam in the system for a pre-determined time; preferably for about 0.5 h.
In a preferred embodiment, the system is maintained at about ≥ 121⁰C.

In another embodiment of the instant disclosure, the process for sterilizing and de-humidifying the system comprises vessel sterilization.
In a further embodiment, the process for sterilizing and de-humidifying the system comprises system pipe sterilization.
For the purpose of the instant disclosure, and as is perceivable to a person skilled in the art, the term “vessel” pertains to any one or more apparatus, reactor, generator, tank, or any other device, feature, component, or system that supports product manufacturing environment, as is described above.
Further, the term “system pipe” relates to a hollow tube with round cross section for the conveyance of products, including one or more fluids and gas.
In an exemplary embodiment, the process for sterilizing and de-humidifying the system comprises vessel sterilization and system pipe sterilization.

A further embodiment of the present disclosure relates to a process for sterilizing and de-humidifying a system; said process comprising, pressurizing and de-pressurizing the system with moving hot sterile air, as described above.
In one embodiment, the moving hot sterile air moves with a linear velocity of about 16 m/s to 22 m/s.
In another embodiment, the moving hot sterile air is sterilized by passing air through the sterilized supply assembly, as described above.

In a related embodiment, the pressurization of the system is carried out at a pressure of about 2.5 bar (g).
In yet another related embodiment, the de-pressurization of the system is carried out at a pressure ranging from about 0.8 bar (g) to 1 bar (g).
In a further embodiment, the pressurization and de-pressurization of the system is carried out in repeated cycles for a pre-validated time; wherein, the pre-validated time preferably ranges from 1.5 h. to 10 h; and particularly ranges from 1.5 h. to 4 h.

An exemplary embodiment of the present disclosure relates to a process for sterilizing and de-humidifying a system; said process comprising, pressurizing and de-pressurizing the system with moving hot sterile air, while maintaining the said system at about 80⁰C to 90⁰C.
In yet another exemplary embodiment, the moving hot sterile air maintains the system at about 80⁰C to 90⁰C.

Second aspect of the instant disclosure relates to an arrangement to sterilize and de-humidify a system, characterized in that, said arrangement comprises, supply assembly configured to charge the supply assembly and/or the system with at least one of steam and moving hot sterile air; wherein, said steam carries out sterilization of at least one of the supply assembly and the system; and said moving hot sterile air carries out pressurization and de-pressurization of the system, while maintaining said system at 80⁰C to 90⁰C; valves configured to direct flow of at least one of said steam and said moving hot sterile air; and sensors configured to monitor process parameters.
For the purpose of the instant disclosure and as is perceivable to a person skilled in the art, the term “arrangement” pertains to an orderly grouping of components described here.

One embodiment relates to an arrangement to sterilize and de-humidify a system; wherein, said arrangement comprises, supply assembly configured to charge the supply assembly and/or the system with at least one of steam and moving hot sterile air, as described above.
In a related embodiment, said steam carries out sterilization of at least one of the supply assembly and the system, as described above; and particularly, steam carries out sterilization of the supply assembly and the system.
In yet another related embodiment, said moving hot sterile air carries out pressurization and de-pressurization of the system, while maintaining said system at 80⁰C to 90⁰C, as described above.

Another embodiment relates to, an arrangement to sterilize and de-humidify a system; wherein, said arrangement comprises, valves configured to direct flow of at least one of said steam and said moving hot sterile air.
An embodiment relates to valves configured to direct flow of said steam or said moving hot sterile air.
An alternate embodiment relates to valves configured to direct flow of said steam and said moving hot sterile air.
For the purpose of the instant disclosure, the term “valve” relates to a device comprising an inlet and outlet passage for controlling the passage of fluid or air.
In a related embodiment, the valve is at least one or more of the conventionally known diaphragm valve, supply valve, isolation valve, connector valve, regulator valve, boundary valve, header valve, entry valve, flush bottom valve, drain valve, and exhaust valve.

In an exemplary embodiment, the valve at least one or more of isolation valves (02, 07, 08), drain valve (09), connector valve (12), steam entry valve (13), a steam entry valve for vessel (15), an isolation valve for spray ball (17), an air supply valve (19), a flush bottom valve (21), a product isolation valve (22), a sterile isolation valve of vessel (23), a condensate drain valve (24), a drain valve of vessel (26), a filter housing drain valve (28), a steam supply valve to harvest assembly (30), a steam isolation valve of harvest assembly (31), a product isolation valve of harvest assembly (32), a product isolation valve at receiving vessel (34), a boundary valve at receiving vessel (35), a drain valve from product transfer assembly (36), and an exhaust valve (20).

In a further embodiment, some of the valves are further configured to synchronously drain condensate from the system.
As per the present disclosure and as is perceivable to a person skilled in the art, the term “condensate” pertains to excess water, moisture, retained in the system; particularly, after sterilization with steam.
In a preferred embodiment, the valves that are further configured to synchronously drain condensate from the system are at least one or more of drain valve, and flush bottom valve.
In an exemplary embodiment, the valves that are further configured to synchronously drain condensate from the system are drain valve (09), a flush bottom valve (21), a condensate drain valve (24), a drain valve of vessel (26), a filter housing drain valve (28), a drain valve from product transfer assembly (36), and an exhaust valve (20).
In a preferred embodiment, said valves are further configured to synchronously drain condensate from the system, such that said sterilized system has zero-water retention.
A yet another embodiment relates to, an arrangement to sterilize and de-humidify a system; wherein, said arrangement comprises, sensors configured to monitor process parameters.
For the purpose of the instant disclosure and as is perceivable to a person skilled in the art, the term “sensors” relate to a device which detects or measures a process parameter and records and indicates.
In an embodiment, the sensors are at least one of temperature sensor and pressure transmitter.
In another embodiment, the sensors are one or more of temperature sensor and pressure transmitter.
In an exemplary embodiment, the system comprises at least one or more of pressure transmitters (05, 18, 33), and temperature sensors (06, 10, 25, 29, 37).

Referring to Fig. 1, in an exemplary embodiment, the sterilization of the supply assembly is carried out by:
charging the steam supply assembly as well as air supply assembly with steam at about ≥ 121⁰C through a connector valve (12); and
further, moving the steam through a steam entry pipe (14), an air filter (03), a heat exchanger (04), pressure transmitter (05), temperature sensor (06), isolation valves (07, 08), and an air header pipe (11), before re-charging the steam supply assembly with the steam at ≥ 121⁰C through a connector valve (12);
wherein, said air supply assembly comprises a steam entry pipe (14), an air filter (03), a heat exchanger (04), pressure transmitter (05), temperature sensor (06), isolation valves (07, 08), an air header pipe (11), and a connector valve (12), and wherein, pressure transmitter (05) and temperature sensor (06) monitor the process parameters – temperature and/or pressure of the system.
In a related embodiment, condensate and/or excess steam is drained through a drain valve (09).
In a further embodiment, the condensate and/or excess steam drained through a drain valve (09) is monitored for temperature using a temperature sensor (10).
In a preferred embodiment, the steam is held in the supply assembly for a pre-determined time; preferably for about 0.5 h.
In yet another preferred embodiment, the supply assembly is maintained at about ≥121⁰C.

Referring to Fig. 1, in another exemplary embodiment, the sterilization of the system is carried out by:
charging the system with steam at ≥ 121⁰C through the steam supply assembly, as described above, and moving the steam through a connector valve (12), a steam entry valve for vessel (15), a spray ball header (16), and an isolation valve for spray ball (17), in a sequence, before charging a vessel; and
further, moving the steam through an air inlet / exhaust filter (27), a flush bottom valve (21), a product isolation valve (22), and a sterile isolation valve of vessel (23), in a sequence, before draining condensate and/or excess steam.
In a related embodiment, condensate and / or excess steam is drained through a filter housing drain valve (28) a condensate drain valve (24), an exhaust valve (20) and/or a drain valve of vessel (26).
In a further embodiment, the condensate and/or excess steam is monitored for temperature using temperature sensors (25, 29).
In a related embodiment, the pressure of the system is monitored using pressure transmitter (18).
In a preferred embodiment, the steam is held in the vessel for a pre-determined time; preferably for about 0.5 h.
In yet another preferred embodiment, the vessel is maintained at about ≥ 121⁰C.

Alternatively, referring to Fig. 1, in yet another exemplary embodiment, the sterilization of the system is carried out by:
charging the system with steam at ≥ 121⁰C through the steam supply assembly, as described above, and moving the steam through a connector valve (12), a steam entry valve for vessel (15), a spray ball header (16), a steam supply valve to harvest assembly (30), a steam isolation valve of harvest assembly (311), a product isolation valve of harvest assembly (322), a product isolation valve at receiving vessel (34), and a boundary valve at receiving vessel (35), in a sequence, for system pipe sterilization, before draining condensate and/or excess steam.
In a related embodiment, condensate and/or excess steam is drained through a condensate drain valve (24), and/or a drain valve from product transfer assembly (36).
In a further embodiment, the condensate and/or excess steam is monitored for temperature using temperature sensors (25, 37).
In a related embodiment, the pressure of the system is monitored using pressure transmitter (33).
In a preferred embodiment, the steam is held in the system pipe for a pre-determined time; preferably for about 0.5 h.
In yet another preferred embodiment, the system pipe is maintained at about ≥ 121⁰C.

Referring to Fig. 1, further exemplary embodiment relates to, charging the sterilized air supply assembly, as described above, with air (moving with a linear velocity of 16 m/s to 22 m/s) through a manual air pressure regulator (01), and an air isolation valve (02), in a sequence, before sterilizing, and heating the air using air filter (03), and a heat exchanger (04), respectively, such that, to obtain moving hot sterile air;
moving said hot sterile air through a pressure transmitter (05), a temperature sensor (06), isolation valves (07, 08), an air header pipe (11), and a connector valve (12), as described above, in a sequence, before charging the sterilized system, as described above, with said moving hot sterile air through an air supply valve (19),
such that, said system is pressurized at about 2.5 bar (g); and
draining the condensate and/or excess steam using some valves, such as, a flush bottom valve (21), a product isolation valve (22), a sterile isolation valve of vessel (23), a condensate drain valve (24), and/or a steam isolation valve of harvest assembly (31), an exhaust valve (20), a product isolation valve of harvest assembly (32), to synchronously drain condensate from the system,
such that said system is de-pressurized at a pressure ranging from 0.8 bar (g) to 1 bar(g) to achieve sterilized as well as de-humidified system.
In yet another related embodiment, the condensate and/or excess steam is monitored for temperature using temperature sensors (25, 37).
In a preferred embodiment, the moving hot sterile air maintains the system at 80 ⁰C to 90⁰C.
In yet another preferred embodiment, the pressurization and de-pressurization of the system is carried out in repeated cycles for about 1.5 h. to 4 h.

In a particular embodiment, the process and/or arrangement, as described above, is analysed for sterility; preferably, by monitoring the temperature of the condensate/excess steam using temperature sensors, as described above; wherein, temperature ≥ 121⁰C; and preferably, ≥ 121⁰C determines sterility, as is known to a person skilled in the art.
In a preferred embodiment, the temperature of the condensate/excess steam is ≥ 121⁰C.
In yet another particular embodiment, the process and/or arrangement, as described above, is analysed for zero-water retention; preferably, by carrying out visual inspection of water droplets, as standardized by USFDA.
In a preferred embodiment, the visual inspection of the system shows zero-water retention.

In an embodiment, the process and/or arrangement, as described above is at least one of open or closed system; and preferably, closed system.

In one embodiment, the process, as described above is at least one of manual, semi-automated, or automated; and preferably, automated.
In another embodiment, the arrangement, as described above is at least one of manual, semi-automated, or automated; and preferably, automated.

In yet another embodiment, the process and/or arrangement, as described above finds application in pharma industry.

Various modifications to the embodiment will be readily apparent to those skilled in the art and the generic principles herein may be applied to other embodiments. However, one of ordinary skill in the art will readily recognize that the present disclosure is not intended to be limited to the embodiments illustrated but is to be accorded the widest scope consistent with the principles and features described herein.
The foregoing description shall be interpreted as illustrative and not in any limiting sense. A person of ordinary skill in the art would understand that certain modifications could come within the scope of this disclosure. The features and properties of the present disclosure are described in further detail below with reference to examples.
The embodiments, examples and alternatives of the preceding paragraphs or the description and drawings, including any of their various aspects or respective individual features, may be taken independently or in any combination. Features described in connection with one embodiment are applicable to all embodiments, unless such features are incompatible.
The preferred embodiments of the present invention are described in detail above. It should be understood that ordinary technologies in the field can make many modifications and changes according to the concept of the present invention without creative work. Therefore, all technical solutions that can be obtained by those skilled in the art through logical analysis, reasoning or limited experiments based on the concept of the present invention on the basis of the prior art should fall within the protection scope determined by the claims. 
, Claims:We Claim:
1. A process for sterilizing and de-humidifying a system,
characterized in that,
said process comprising:
sterilizing supply assembly;
sterilizing the system; and
pressurizing and de-pressurizing the system with moving hot sterile air, while maintaining said system at 80⁰C to 90⁰C.

2. The process as claimed in claim 1, wherein the sterilization of the supply assembly is carried out by:
charging the supply assembly with steam at ≥ 121⁰C; and
holding the steam in the supply assembly at a pre-determined pressure for a pre-determined time;
such that,
said supply assembly is maintained at ≥ 121⁰C.

3. The process as claimed in claim 1, wherein the sterilization of the system is carried out by:
charging the system with steam at ≥ 121⁰C;
and holding the steam in the system at a pre-determined pressure for a pre-determined time;
such that,
said system is maintained at ≥ 121⁰C.

4. The process as claimed in claim 3, wherein said process comprises at least one of vessel sterilization and system pipe sterilization.

5. The process as claimed in claim 1, wherein the moving hot sterile air moves with a linear velocity of 16 m/s to 22 m/s.

6. The process as claimed in claim 1, wherein the moving hot sterile air maintains the system at 80⁰C to 90⁰C.

7. The process as claimed in claim 1, wherein the moving hot sterile air is sterilized by passing air through the sterilized supply assembly as claimed in claim 2.

8. The process as claimed in claim 1, wherein the pressurization of the system is carried out at 2.5 bar (g).

9. The process as claimed in claim 1, wherein the de-pressurization of the system is carried out at a pressure ranging from 0.8 bar (g) to 1 bar (g).

10. The process as claimed in claim 1, wherein the pressurization and de-pressurization of the system is carried out in repeated cycles for a pre-validated time.

11. The process as claimed in claim 10, wherein the pre-validated time ranges from 1.5 h. to 4 h.

12. An arrangement to sterilize and de-humidify a system,
characterized in that, said arrangement comprises:
supply assembly configured to charge the supply assembly and/or the system
with at least one of steam and moving hot sterile air;
wherein,
said steam carries out sterilization of at least one of the supply assembly and the system; and
said moving hot sterile air carries out pressurization and de-pressurization of the system, while maintaining said system at 80 ⁰C to 90 ⁰C;
valves configured to direct flow of at least one of said steam and said moving hot sterile air; and
sensors configured to monitor process parameters.

13. The arrangement as claimed in claim 12, wherein some of the valves are further configured to synchronously drain condensate from the system.

14. The arrangement as claimed in claim 12, wherein the sensors are at least one of temperature sensor and pressure transmitter.

15. The arrangement as claimed in claim 12, wherein the system comprises at least one of vessel and system pipe.

Dated this 19th Day of October 2023

Vaishali K. Sajjan [IN/PA-1980]
For PRAJ HIPURITY SYSTEMS LTD