Intertech Technologies Pvt. Ltd.

INTERTECH has long back recognized the added benefits of Magnetic Mixers for ultra sterile operations. The vessel shell is not penetrated and there are no mechanical seals. This prevents toxic or high value media from leaking out of the vessel. Magnetic Mixers are suitable for viscosity up to 1000 cps at operating temp. Magnetic Mixer range offers great batch flexibility, because a relatively small volume of product will cover the impeller-mounted very close to the vessel bottom. Bottom mounting also leaves the top of the vessel clear for easy vessel access.

Magnetic Mixer has a drive mechanism that can be removed quickly and easily – a major advantage, because small vessels can then be autoclaved rather than sterilized-in place (if preferred). All product contact parts are stainless steel 316L, with special grade tungsten carbide bearing surfaces. These allow smooth trouble free operation and are an integral part of the impeller head and carrier. The open impeller design allows easy cleaning and can easily be removed for separate cleaning and sterilization. INTERTECH Magnetic Mixers are fully engineered & designed for better CIP/SIP compliances.

Note:

• The mixing capacities above are based on aqueous like products with a density of 1000kg/m3 (S.G.=1) and a viscosity of 1cp.
• Typical applications for 'Gentle' mixing are where solids are held in suspension.
• Typical applications for 'Blending' are where soluble liquids are mixed together or where powders easily dissolve into the liquid.
• Typical applications for 'Vigorous' mixing are where a vortex is required for blending of powders into a liquid.

Technical Specifications:

 

 

Multi Column Distillation Plant is based on FINN-AQUA design. It consist of specially designed columns which make optimum use of the principles of inter stage heat exchange (Multi effect distillation method) to produce pure pyrogen free sterile distilled water for injectables as per IP/BP specification. The vapour with high velocity and under pressure passes over a SPECIALLY DESIGNED SPIRAL BAFFLE system which develops tremendous centrifugal force and thus eliminates any chances of pyrogens carry over in the vapours.

To industries where 100% pure Pyrogen - free water-for injection plays role, Multicolumn Distillation Plant is the perfect solution. Available in capacities ranging, the Multicolumn Distilled plant is used for its economy, low maintenance and low operation costs.
By Multi Effect Distillation method significant energy (75% approx) is saved when compared to the conventional method. All contact parts are made out of AISI 316 quality stainless steel and mirror polished. All pipes and tubes are essentially seamless.

Operation :

The pre-heated feed water (through condenser) is fed into the first column where 33% of feed water is converted into steam under pressure by outside boiler steam. The pure steam produced in the first column having temperature of 135 degree Celsius and the remaining feed water goes to the 2nd column. The pure steam is used as a heating media in the 2nd column and converts part of remaining feed water into steam. In the process the steam itself condenses back into water. This process is repeated till the last columns each working at low temperature & pressure as compared to the one before it. The steam produced in the last column is condensed in the condenser by feed water as well as cooling water. As external heat is required only to convert the 33% of feed water, the heating energy required is reduced by 67%.

CONSTRUCTION DETAIL:

• Distillation column houses the heat exchanger & pyrogen separation system.
• Heat exchanger in first column with Double Tube Sheet Design as per USP requirement.
• Common condenser at the end of distillation process to condense steam & separate gas from distillate
• Vent on the condenser is with 0.2 micron bacteria retentive filter for safe shut down.
• All seamless pipe with orbital welding inspected by boroscopic procedure.
• Designing is as per ASME std. All surface finish better than 0.3 Ra.

SALIENT FEATURE:

• Total energy saving is 75% as less heating energy and less cooling water is required.
• Pyrogens are removed by centrifugal force developed & specially designed spiral baffle.
• All contact parts are s.s.316 quality. All pipes and tubes are seamless and gaskets made form teflon.
• Distillate Temperature is quite high.( 90-95')
• Distilled water as per IP/BP standards and conductivity less than 1 micromhos/cm.
• Online temp. monitoring of WFI
• Conductivity monitoring and control for feed water & WFI
• Automatic feed water control to prevent column flooding.

INTERTECH offers you a full range of capabilities in the supply of portable sterile filling vessels. Our engineering and manufacturing staff has decades of experience in the design and manufacture of portable vessels with heat transfer, agitation, top-head manhole and virtually any other requirement that might exist. Our extensive manufacturing capabilities allow us to keep the entire scope of your portable vessel fabrication in-house. We manufacture 100% of the heads, shells, manhole, and heat transfer surface within our facility. This, as well as our own electro-polishing capability, allows us to control the entire scope of supply of your tank or vessel. Outlet nozzle fitted with a long pipe, which draws out all the liquids from the container. Top lid clamping type fitted with a glass for visual inspection. Vessel is argon arc welded with smooth finished corners and highly polished from inside and out side. The vessel is provided with 2 handles for lifting with S.S. 304 trolley with castor wheels. Complete as per our standard. These vessels are tested at 2 bar pressure, round in shape at top.

We offer full Factory Acceptance Testing (FAT) and extensive standard documentation packages, or we can supply a custom package to meet your project's specific needs.
CONSTRUCTION FEATURES:

• High purity sterile surfaces 100 % drain-able
• 100 % CIP enabled with confirmation by Riboflavin Test
• 100 % SIP enabled from dead leg areas Plug and play
• Fabrication as per ASME / BPE code
• Operation control available in various modes i.e. Manual / Semi Automatic / completely Automatic with high performance control systems i.e. PLC /HMI/ SCADA Automation designed to latest GMP standards which are compliant to 21CFR Part 11 and other Applicable codes as required / defined in URS

Sterilization in simple terms, refers to any process that effectively kills or eliminates transmissible agents (such as bacteria, viruses, spore forms etc.) from a surface, equipment or biological culture medium. Sterilization can be achieved through application of heat, chemicals, irradiation, or filtration. Of these, heat (steam) sterilization is proven to be the most effective.

No living thing can survive direct exposure to saturated steam at 250 F (120 C) longer than 15 minutes. Hence death / destruction of microbial life is necessary to achieve sterilization. Steam, for a specified time at required temperature, must penetrate every fiber and reach every surface of items to be sterilized. When steam enters the sterilizer chamber under pressure, it condenses upon contact with cold items. This condensation liberates heat, simultaneously heating and wetting all items in the load, thereby providing the two requisites: moisture and heat.

There is exact demand of temperature /pressure control, process accuracy and documentation to adhere sterilization truly. Now based on the application demand, Steam Sterilizers are categorized mainly into four categories :

1. GRAVITY DISPLACEMENT STEAM STERILIZERS

Empty glass ware , utensils , vessels instruments & lab scale articles are best sterilized in these sterilizers. The technique uses the method of gravity air removal to ensure uniform steam distribution & penetration.

2. VACUUM STEAM STERILIZER

Porous material like garments, fabrics, machine & changed parts, bulk powders etc. are best sterilized in these Sterilizers. The technique uses mechanical air removal thru Vacuum pump & ensures 100% air removal which results in better temperature uniformity in the chamber. There is better steam penetration in porous products & vacuum drying at the end ensures drying of the material which was sterilized.

3. RAPID COOLING STERILIZER

Terminal sterilization of ampoules, glass bottles & sterilization of heat labile products are best achieved in these sterilzers. Here compressed air is used to create over pressure which accelerate steam evacuation from chamber & also provides counter pressure to ensure container / bottle integrity. Atomized water spray cools the load within chamber.

4. VACUUM TEST STERILIZER

Glass ampoules with fine line crack occurred during manufacturing , filling gets busted when exposed to vacuum due to high differential over wall.

CONSTRUCTION DETAILS

1. Chamber is double walled with inner SS 316/SS 316L & outer in SS 304 with jacket in between
2. Slopping bottom for condensate removal.
3. Fully automatic horizontal sliding door and Hinged door with automatic locking
4. A safety device prevents the operator from opening the door when chamber is pressurized
5. Steam is not allowed into the chamber when the door is open
6. A cycle will not start if the door is open or not properly closed
7. The door cannot open until chamber pressure reaches room pressure
8. Double Door Safety – interlocks prevent both doors from being opened simultaneously

SALIENT FEATURES

• PLC validation as per 21CFRpart11
• Dimple jacket of SS 316 L provided for enhanced / uniform and temperature distribution (within ± 1° C during the sterilization phase.
• Multiple validation ports
• Bio seal : A biological safety barrier separates the sterile and non -sterile zone.
• Integration of sterile section with isolator
• Trays, carriage and floor trolleys provided.
• Pneumatically operated sliding doors with safety interlocks
• Dedicated after sales service with well trained technicians

Due to our years of expertise in this realm, we are readily affianced in presenting an exceptional quality variety of Injection Plant These are made in tune with the industry guidelines and by making use of quality assured material that are acquired from certified vendors of the industry. This range can be acquired at very reasonable rates.

Features:

• Sturdy
• Excellent
• Durable

INTERTECH has developed TERMINAL STERILIZER which uses Super Heated Water at higher pressure to sterilize Vials & PE containers to overcome the drawbacks associated with conventional steam sterilization & to meet the demands of recent Pharmaceutical Regulations. These Sterilizer are also called Super Heated Water Spray sterilizer. The Sterilizer uses super heated water as the sterilization medium and hence allows the user to modify the fixed temperature - pressure relationship associated with Steam Sterilizers.

OPERATION :

The Product is loaded in the sterilizer on specially designed loading carriages. Process water (usually de-ionized water) is filled in the chamber up to a predetermined level. The water is drawn by a sanitary construction centrifugal Pump, passed through the heat exchanger and sprayed over the load. A distribution network and spray manifold ensures a very uniform spray over the product (load). During the heating phase of the process externally generated steam is supplied to the heat exchanger. This Steam heats the process water flowing on the secondary side of the heat exchanger. The temperature of the product is gradually increased from ambient to the sterilization temperature. The heating rate is settable over different temperature range to minimize the thermal shock to the product. During the heating phase the air compensation system is also operational. This system maintains the chamber pressure at pre-determined levels over the temperature range, thereby ensuring minimal pressure difference between the chamber and the container. This pressure balancing action continues throughout the process. After attainment of the sterilization temperature the Sterilization timer starts. The sterilization temperature is maintained, for a settable duration, by automatic regulation of incoming steam supply. During the cooling phase the steam supply to the heat exchanger is switched off and cooling water supply is switched on. The product is then cooled at a settable rate to the unloading temperature. At the end of the process the load is unloaded. The process water, if required, can be reused.

SALIENT FEATURES:

EXCELLENT HEAT TRANSFER:

INTERTECH SHWS Sterilizers the uniform water shower over the product ensures that a uniform temperature distribution is maintained throughout the chamber during the sterilization phase. Moreover since the water comes into physical contact with the product the heat transfer is more efficient and the process efficiency is not affected by air pockets, a problem common with steam.

SUPERIOR CLOSED LOOP SYSTEM:

The SHWS Sterilization process uses a closed loop system for the process water. The main advantage is that the water becomes sterilized during the process and hence presents no hazard to the product. This ensures compliance to regulations for cooling sealed containers during sterilization.

PRESSURE COMPENSATION SYSTEM:

Steam Sterilizers have a serious drawback when sterilizing flexible containers. The constant temperature-pressure relationship in these systems result is the flexible containers collapsing or bursting during the process.
INTERTECH SHWS Sterilizers the temperature and pressure can be independently controlled depending on container material, size and the liquid being sterilized.

PROCESS MANAGEMENT SYSTEM:

The SHWS Sterilizers are provided with microprocessor controlled system. This also comprises of a operator terminal and printer. The system is provided with 10 user defined programs. More versatile computer controlled system are also available on request.