INJECTABLE

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ULTRASONIC AMPOULE & VIAL WASHER

SALIENT FEATURES

  • Provides option to be part of a compact line or work independently.
  • Smooth and quiet singling out of ampoules in the ultrasonic bath.
  • Improved quality of ampoule cleaning due to elimination of energy absorbing transfer components in the ultrasonic bath.
  • Quick and simple cleaning of recycling water tank through a large opening at the tank bottom.
  • Speedy change-over due to less sized parts.

DESIGN FEATURES

  • All parts of the machine that come into contact with the cleaning media are made of stainless steel. All surfaces coming in contact with the ampoules / vials are manufactured of stainless steel or specially selected plastic materials. The stainless steel parts are additionally hard chromed to give a smoother surface and make it less susceptible to wear.
  • The infeed and discharge are opposite each other, clearly separating the ampoule infeed from the cleaning process. The jetting media are fed through separate pipes to the jetting stations.
  • In order to reduce water consumption an easily accessible recycling station is installed inside the machine. The drive is infinitely adjustable.

    OPERATION

  • The ampoules / vials can be fed directly from the supplier’s cartons into the infeed chute. From there, passing under a shower head, they are immersed in the heated ultrasonic bath. In the water bath the ampoules / vials are singled out into reciprocating lanes. The individually positioned ampoules / vials are pushed into the cones of the centering bar by pushers and then fed directly on to the jetting needles. The jetting wheel works intermittently and feeds the ampoules to the jetting stations in the upper station.
  • The ampoules / vials are blown of the jetting needles and lifted into the discharge tray. At this point the ampoules can be either trayed or fed directly on to the conveyor belt of the sterilizing tunnel.

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AUTO LINEAR VIAL WASHER

WASHING SYSTEM

  • Machine provides 4 water washes & 3 air washes.
  • Complete flexibility with user for washing cycle.

APPLICATIONS

  • Suitable for washing of Vials (2ml to 30ml)(dia. 14mm to 38mm).

    GMP

  • All Contact parts made out from SS 316. Entire frame covers & non contact parts made out from SS 304.
  • Nozzles enter into the container during washing cycle to meet cGMP requirement.
  • Low water consumption.
  • Quick change over with minimum use of tools.

    OPERATION

  • Containers fed from the decartoning station (optional)are received on a unscrambler through Visual Inspection Unit (optional). An infeed worm inverts container to neck down position and feeds them through a specially designed indexing device carries the container forward and stops.
  • Nozzles carrier enters into the container and activates the jet of water / air. The air / water flow is deactivated after the washing cycle is over.
  • Device indexes the vials for next wash.
  • A separate pumping station (optional) gives the right quantum of water at the desired pressure.
    In the absent of separate pumping station we can provide the recirculation & siliconization system on request.
  • Washed containers are again inverted to neck upward position to collect in trays / directly feed to tunnel.

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ROTARY VIAL WASHER

SPECIAL FEATURES

  • Water Through.
  • San type Centrifugal Pump.
  • Wash Schematics:
    • Station 1 Recirculatory water INT + EXT
    • Station 2 Recirculatory water INT
    • Station 3 Fresh water INT + EXT
    • Station 4 Fresh water INT
    • Station 5 Air INT + EXT
  • Main drive fitted with frequency invertor for variable speed adjustment.
  • Filters:
    • S.S.316 housing with polypropylene filter elements 20 micron, 250mm long for recirculated water.
    • S.S.316 housing with polypropylene filter elements 5 micron, 250mm long for fresh water from loop.
    • Oil free compressed Air Filter Domnick Hunter for sub-micronic retention upto 0.1 micron. (Pre-filtration down to 5 micron & the pressure regulator to be provided by buyer)
    • Air receiver.
  • Pressure Switches with regulator.
  • Pneumatic solenoid operated valves.
  • Float switch for water tank.
  • Air lubricator
  • Loading station with unscrambler at infeed to washer.
  • Washer outfeed mechanism, with loading device to tunnel conveyor.


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STERILIZING TUNNEL

SPECIAL FEATURES

  • Four Zone Construction: Drying, sterilizing, cooling & stabilizing zones. The drying, cooling and stabilizing zones is minipleat patented GRADVEL separator less HEPA filters, with supply air to the modules taken from the room and most of the air quantity exhausted. The sterilizing zone is a recirculatory module with patented Hot minipleat separator less HEPA filters, with Incoloy heater elements placed in the air path.
  • All structural elements in duly passivated steel. Air containment and container contact parts including wire link conveyor is in S.S.304 External paneling in S.S.304.
  • Operating Temperatures plus 330 deg. C with container temperatures reaching 280 deg. C. Minimum Endotoxin reduction of log 3.
  • Differential pressure is monitored in drying, sterilizing and cooling zones on individual Magnehelic pressure gauges.
  • Conveyor drive fitted with frequency invertors for variable speed adjustment.
  • A fully wired control panel in S.S.304 cabinet, with PLC controls, and temperature plotting on an 80-column printer.
  • The tunnel is suitably integrated at the in feed with washer & at the out feed with filler sealer.
  • S.S. 304 Biophragm on Sterilizing Tunnel for sealing sterile zone from non-sterile zone. Magnehelic differential pressure gauge for over-pressure monitoring across the filling room.
  • Rotary unscrambler dia 600 mm with SS 304 contact surface, with mechanically variable speed drive, resulting in single line feed to the delrin conveyor of the filter-bunger.

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MANUFACTURING VESSEL

Design Purpose : Storage / Mixing.

Type : Vertical.

Capacity (ltrs)
a. Working - 300/400.
b. Gross - 360/480.

Material Of Construction
a. Shell - SS 316.
b. Jacket - SS 304.

Working Pressure (Test Pressure 1.5 times the Working Pressure)
a. Shell - 2.0 kgs/cm2.
b. Jacket - 2.0 kgs/cm2.


Space Between Shell & Jacket : 40 mm.

Lugs & Legs (Bolting Type) : 4 Nos.
a. Material : SS 304.
b. Legs : Round Flange to be provided with 4 Nos. Holes.

Stirrers
(i) Turbo for Mixing Tank :
a. Speed Single Speed.
b. Mechanical Seal Cartridge Type Double Acting Mechanical Seal With flow Switch For Cooling,
c. Surface TC/TC.
d. RPM 1440

(ii) Propeller For Syrup Preparation :
a. Speed Fixed.
b. Mechanical Seal Cartridge Type Double Acting Mechanical Seal With flow Switch For Cooling.
c. Surface TC/TC.
d. RPM 960.

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MEMBRANE FILTER HOLDER

Membrane Filter Holders

  • The membrane holders in combination with membrane filters are used for sterile filtration of pharmaceuticals and biological solutions. On a production scale either a 290 mm or a 142 mm dia. holder is used. The selection of the holder depends upon the volume of the liquid to be filtered in a day. Both the 293 mm dia. and 142 mm dia. holders are made of SS 316 and are supplied with removable legs. The filter support screen is offered in SS with polished surface. The inlet and outlet connections are of sanitory triclover design on larger model holders for cleaning and maintenance. All these holders are provided with air vent valves. This valve has to be opened to release any air that could be trapped in between and may offer resistance to the flow of the liquid during the process of filtration.
  • The sealing rings can be offered in silicon and grip knobs are provided to tighten them. The membrane filter support screen has an under drain support.
  • A flow deflector under the top plate ensures even distribution of the liquid flow. A back pressure support screen may also be supplied to protect the filter against reverse accidental flows (Always use a prefilter while using back pressure screen).

    Bubble Test Arrangement

  • Bubble Point Test is a non-destructive test to check the integrity of the membrane filter, before and after the filtration. The bubble point is the pressure required to force air through the pores of a wet filter. If a membrane can not withstand the pressure below bubble point level, it indicates peak in the filter. A built-in system for bubble testing can be provided with the membrane holders by in -building a set of liquid and air control valves.

Laboratory / Inline Filter Holders

  • For sterilizing small volumes of liquids, Small size membrane filter holders are available in three sizes, viz. 13 mm, 25 mm & 47 mm. All holders are made of SS 316 with silicon sealing gaskets and SS filter support screen.

    STERILE TEST UNITS

Mechanism:

  • A 47 mm membrane filter is installed in a suitable holder. The liquid sample is drawn through this sterile membrane filter to concentrate any contaminating micro-organisms on the filter surface. After filtration is completed, sterile flushing fluid is passed into the funnels, rinsing all sample residue through the filters so that it cannot possibly inhibit growth of the retain micro organisms. After this, the filter is sectioned and asceptically transferred to media for culturing. If growth is not visible after the incubation period, the sample passes the test.

    Technical Features:

  • Six Place and three place test units are available to simultaneously filter five or two test samples, respectively with a concurrent control filtration of sterile diluting fluid for an immediate overall verification of system sterility. The sterility testing manifolds are made out of SS material. The entire unit can be autoclaved. Essential parts of the units are a combined manifold for vacuum and flushing, filter holders and three way valves.

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PRESSURE VESSEL

Salient Features:

  • These vessels are manufactured from High Alloy Stainless Steel AISI 316 quality.
  • All joints are tig welded. Gaps & dead corners are reduced to an absolute minimum.
  • The interior and exterior of all vessels are mirror finished.
  • A long tube is provided to ensure complete drawing for fluid.
  • These vessels can be put in an autoclave and be steam sterilized.
  • Models up to 20 ltrs. are provided with hand wheel type covers and on higher capacity models, flange cover with wing nuts are provided.
  • Each vessel is tested at 6 kg /cm2 pressure.
  • A pressure relief valve is provided.
  • Standard models are available upto 200 ltrs. capacity. Higher capacity units can also be fabricated.
  • SS Mobile Trolley for easy movement, can also be provided.

 

 

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STERILE FILLING VESSEL

Salient Features:

  • These vessels are manufactured from high alloy stainless steel (AISI 316) quality.
  • All joints are tig welded. Gaps and dead corners are reduced to an absolute minimum.
  • The exterior and interior of all vessels are mirror finished
  • A long tube is provided to ensure complete drawing of the fluid.
  • These vessels can be put in an autoclave and be steam sterilized.
  • An air tight lid with a sight glass is provided.
  • A sterile vent filter can be supplied with the unit as an accessory.
  • Standard models are available between 20 to 200 ltrs.
  • SS mobile trolley for easy movement can also be provided.

 

 

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AMPOULE FILLING & SEALING MACHINE

SALIENT FEATURES

  • Enduring accuracy with enhanced flexibility.
  • High productivity due to reduced idle time and optimization of operating time.
  • High precision ensured as innovative designed.
  • CNC technique used for manufacture of major parts.
  • Infinitely variable speed to achieve optimum production.
  • Easily replaceable change parts with minimum setting time to accept different sizes of ampoules.
  • Easy and instant off-loading from the moving rack as the machine stops.
  • Swift and convenient access to controls.
  • A backlit display for production, machine speed, and machine stop.
  • No spillage of liquid if ampoule is missing from filling station.
  • Transfer of ampoules from infeed conveyor to moving rack with the help of a worm and a segment at very high speed without breakage.
  • Smooth operation even by an inexperienced operator.
    All controls through a Programable Logic Controller

    OPERATION

  • Infeed conveyor is to be fed with ampoules out of magazines, or directly from a pre-connected machine.
  • The ampoule loaded on to a conveyor belt are fed to a screw conveyor in the upright position. The screw conveyor transports the ampoules on to a segment wheel to be carried on to a conveying cradle. The conveying cradle carries the ampoules step by step through the stations in the vertical position

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TERMINAL STERILIZATION

  • Specifications
  • Capacity 25,000 ampoules per charge.
  • Horizontal Rectangular High pressure - High Vacuum, Steam Sterilizer having chamber size. Suitable for working pressure of 16 / 18 psig (121deg. C temp.). The unit will have chamber in S.S. 316 with a double-hinged door in S.S. 316 construction.
  • Unit will be designed to sterilize non-porous loads. It will be used for terminal sterilization of filled ampoules. This sterilizer will have spray water arrangement for quick cooling of the load at the end of cycle.
  • The jacket will be of SS. 304 sheet insulated with ceramic blanket and finished with SS. 304 cladding. The unit will be complete with standard fittings such as pressure gauge, compound gauge, dial thermometer, safety valve, condensate discharge line with steam trap and ports for 5 temperature probes, pneumatic safety locks, along with a 1" Validation Port. The control panel is in S. S. 304 and fitted with PLC / Microprocessor.
  • 80 - column printer, electrically operated with 5 Pt - 100 probes mounted at suitable locations all over the autoclave, duly connected to printer.
  • Standard pressure reducing station for steam, complete with strainer, non-return valve and pressure gauge.
  • Filtration system consists of 10" long sintered SS. 316L element of 20 micron prefilter & 5 micron final filter with suitable housings in S. S. 304.
  • Vent filter for vacuum break with sterile air into the chamber, with filtration down to 0.3 micron having ½" BSP (male) connection and suitable SS piping to the vent port on the autoclave.
  • The loading cage will be in S. S. 316 framework with rolling wheels and S. S. Angles for four adjustable shelf. - 1 No.
  • S. S. 304 Transfer cart with railing and suitable locking arrangement. - 2 Nos. SS 316 Solenoid Valve for Vacuum Pump.

 

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LAMINAR AIR FLOW

OUTSTANDING ADVANTAGES

  • Effective and continuous “clean down” of working area.
  • “Grey” areas in the clean air work environment avoided by elimination of “picture frame” effects and induction leakage - a result of Superior Engineering Inputs.
  • Vibration and noise levels well below specified limits - a result of carefully balanced motor blower assembly with special bearings and a unique suspension mounting.
  • Modular construction, adaptable to incorporate a variety of optional features and ancillary equipment to meet application needs.
  • Rugged construction resulting in long, trouble free services.
  • Stringent performance tests on each LAF unit prior to dispatch, ensuring conformity with international standards.
  • Timely and effective after sales Support, including continual validation.

    AREAS OF APPLICATION

HORIZONTAL :

  • The independent floor-standing unit is the most favoured designed for microbiological manipulations, bio-assays, sterility testing and research in allied fields ; Semi automatic vial filling and bunging operations in parenteral production ; hospitals, pathological laboratories ; microelectronics, optics, and general dry-processing work in semi conductor manufacture ; research and development work ; food and beverage, agriculture, animal husbandry, aerospace and avionics.

    VERTICAL:

  • This flow pattern is favoured for dry processing applications in semiconductor manufacture ; automatic filling lines in parenteral production ; investigative work with mildly toxic materials in microbiological and other research control laboratories ; protection for open vessels of chemicals, solvents or powder ; general assembly work.

STANDARD VERSION

STANDARD VERSION

INCLINABLE & HEIGHT ADJUSTABLE
Inclinable and Height Adjustable configuration :
This simple and portable unit produces a unidirectional flow clean air space at an inclination over the work area the angle of flow is adjustable for optimal orientation.

 

STANDMOUNTED DUPLEX
Duplex Configuration : This exclusive TWIN horizontal Laminar Flow unit, available also in standard version has been designed to provide an economic means of countering contamination control problems with optimal utilization of valuable floor space.

 

DELUXE VERSION
Deluxe Configuration : This immaculately profiled and carefully designed configuration is popular because of the inbuilt storage cabinet facility and rugged maintenance free, all wood melamine laminated construction.
SLIM VERSION
Slim Configuration : This unit with motor blowers are pre-filtered on one side, and access panel for HEPA filters on the other, is also preferred for powder handling by incorporating a return air plenum connected to the pre-filters.

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AMPOULE / VIAL INSPECTION MACHINE

SALIENT FEATURES

  • All contact parts expects the rack are made from SS 304.
  • Spinners are provided with acrylic covers with grooves to detect cracks, charring etc. on mouth of the ampoules / vials.
  • Compact ejection system occupies very little space.
  • RPM of spinners can be adjusted to give desired vortex on liquid.
  • High quality lens reduces operator eye strain.
  • Minimized breakage of ampoules / vials due to adequate bearing points on spinners.
  • Easy access for cleaning and maintenance.
  • Short transport time as compared to inspection time.
  • Facility of repeat cycle.

OPERATION

  • The filled ampoules / vials are loaded into the infeed chute from where they are transferred in batches by an index wheel onto a linear transfer rack.
  • The rack transfers the ampoule / vials on to the inspection station, where spinners spin the ampoules / vials at a predetermined RPMso that a vortex is formed. Light coming from behind the ampoules / vials magnifies all particles / fibers with the help of the lens.
  • The ampouleb / vials are rejected by pressing rejection switches ergonomically located for the operator convenience. A numbered light kept just above the magnifying lens within the operator’s field of vision lights up indicating the ampoules vials which have been rejected.
  • In case a recheck is desired before checking the next lot, a facility for repeat cycle is provided.
  • The ampoules / vials batch is then transferred onto the rejection station where the ampoule / vials rejected at the inspection station are automatically rejected out. A number light lights up above the lens indicating a positive rejection taking place.
  • The accepted ampoules / vials are transferred on to the collection station where they are collected in the tray.

 

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