Injectable Projects

Product Details:

Steam Sterilizer are the most versatile and flexible designed manufactured by Neelam industries to meet the widest requirements of the Pharmaceutical Industry.

Features :

• The equipment is low on operating cost and fast with autoclaving cycle and possess dimple steam jacket for uniform heat distribution.
• Available in single as well as double door with sliding or hinged door option.
• Available with automatic printing facility to control heat labile materials.
• Touch screen is present to measure connection signals, printers and process control visuals.
• The connections are supported by remote control.
• The printing and recording is in confirmation with 21 CFR PART 11.
• Sterile air filter is available for vaccum break.
• An optional SIP filter is also provided as per the requirements.
• To prevent the cross-flow of air between the clean and unclean area, a contamination seal is provided.
• To insert the temperature sensors, which support thermometric testing, validation ports are provided.

Programs :

• HPHV Cycle
• Fast Exhaust Cycle
• Slow Exhaust
• Chamber Leack Test Cycle
• Bowie Dick Test Cycle
• AOP Cycle ( FOR Liquid Solution Sealed in Ampoule & Vial )

In Compliance With :

• cGMP, GAMP, ISO 9001 : 2008

Main Applications :

• Empty glassware (e.g. vials, ampoules, bottles)
• Stoppers
• Inox equipment and instruments
• Inox machine parts
• Empty containers
• Filters and accessories
• Rubber materials
• Textiles

Product Details:

Fully Automatic Horizontal Autoclaves manufactured by Neelam industries are the most versatile and flexible designed to meet the widest requirements of the Pharmaceutical Industry.

Features :

• Dimple steam Jacketed for better Uniformity of the heat Distribution. ( Technology for fast Sterilization cycle and low cost operating ).
• Single or double door with Sliding or Hinged door options
• Automatic Printing facility for control in case of heat labile materials.
• The touch-screen for visual process control and connections for measuring signals and printers.
• Remote support connection
• Online Printing and recording confirming to 21 CFR PART 11.
• 0.2 bacteria retentive, sterile air filter for vacuum break. [Optional SIP facility can be provided]
• Contamination Seal to prevent cross-flow of air between the clean and unclean area.
• Validation ports for insertion of temperature sensors for thermometric testing.

Programs :

• HPHV Cycle
• Fast Exhaust Cycle
• Slow Exhaust
• Chamber Leack Test Cycle
• Bowie Dick Test Cycle
• AOP Cycle ( FOR Liquid Solution Sealed in Ampoule & Vial )

Product Details:

Dry Heat Sterilizer finds application for humidity sensitive materials such as glassware and metal containers that can be sterilized by steam sterilizers but cannot depyrogenate the load.At Neelam Industries, we assure the performance of DHS meeting the following specifications.

• STERILIZATION: Reduction of microbial spore forms up to 12 log reduction.
• DE-PYROGENATION: Denaturing of microbial endotoxins in the material.

FEATURES :

• Neelam Industries depyrogenation steriliser are capable of performing up to 280 ° C, during the entire cycle. We have achieved this, due to our unique chamber construction and filter suspension system, and our never ending work for further improvements.
• High Temperature Hepa Filters High Temp HEPA filters are installed at inlet and exhaust side of the DHS. The HEPA-filters inside the chamber are equipped with full depth and height of chamber for suspension system solving the particle problem during heating and cooling.
• Chamber The Neelam Industries depyrogenation steriliser is made of stainless steel 316L. The chamber is fully welded inside, no leakage to the insulation can occur and the chamber is very easy to clean. The water cooling element is a continuous welded unit without any connections inside the cabinet boundary. It is pressure tested and is expected to last the lifetime of the steriliser.
• Door gasket As standard, Neelam Industries sterilizers are equipped with double door gaskets (FDA-approved). The purpose of dou­ble door gasket is to render maximum security, allowing no leakage between the chamber and the out­side.
• Further more the double gasket minimizes the surface temperature of the sterilizer, and any undesired air flow in the sterile area.
• Superior air control - Guarantee for complete sterilization Neelam Industries depyrogenation sterilisers operate in accordance with the forced convection principle with fast air circu­lation securing a rapid heat transmission to the load. Together with the shape and position of the electrical heating element, the calculated air distribution plates ensure a unique temperature distribution in the sterilization chamber. The temperature distribution is tested and fixed before delivery and does not require any adjustments in the life time of the steriliser, accordingly no down time for re-validation is needed. The uniform temperature in the chamber make it possible to fix the set-point temperature very close to the required minimum temperature for the sterilization.
• Program Cycle The cycle of a Neelam Industries steriliser is fully automatic.
• Drying The cycle starts with the drying phase where the damper on the exhaust is open ensuring, that any moisture will be removed from the chamber.
• Heating At a set-point temperature decided by the customer, the damper will close and the temperature will rise to the sterilizing set-point temperature. The damper will also stay closed during sterilization. Neelam Industries Sterlisers are equipped with a powerful heating element to shorten the heating time
• Sterilizing The sterilizing timer can be started by the load sensors. The sterilizing timer will only be running if all the load sensors are within an acceptable range from the sterilizing set-point.
• Cooling If the cycle time is important, forced air cooling or water cooling is avail­able for rapid cooling in customized model.

Product Details:

Neelam Industries Stainless steel autoclave manufactured by Neelam industries are the most versatile and flexible designed to meet the widest requirements of the Pharmaceutical Industry.

Neelam industries offer any specific sterile requirement and meet User's R & D and Production requirement with Standard or customized model of sterilizer.

Features

• Dimple steam Jacketed for better Uniformity of the heat Distribution. ( Technology for fast Sterilization cycle and low cost operating ).
• Single or double door with Sliding or Hinged door options
• Automatic Printing facility for control in case of heat labile materials.
• The touch-screen for visual process control and connections for measuring signals and printers.
• Remote support connection
• Online Printing and recording confirming to 21 CFR PART 11.
• 0.2 bacteria retentive, sterile air filter for vacuum break. [Optional SIP facility can be provided]
• Contamination Seal to prevent cross-flow of air between the clean and unclean area.
• Validation ports for insertion of temperature sensors for thermometric testing.

Programs

• HPHV Cycle
• Fast Exhaust Cycle
• Slow Exhaust
• Chamber Leack Test Cycle
• Bowie Dick Test Cycle
• AOP Cycle ( FOR Liquid Solution Sealed in Ampoule & Vial )

Product Details:

Neelam Industries’s Steam Sterilizer are most versatile and flexible designed to meet the widest requirements of the Pharmaceutical Industry.

Available in single as well as double door with sliding or hinged door option.The equipment is low on operating cost and fast with autoclaving cycle and possess dimple steamjacket for uniform heat distribution.Available with automatic printing facility.Touch screen is provided to measure connection signals, printers and process control visuals.Remote Support facility for Prompt after sales services.21 CFR PART 11 Compliance with Audit Trial in PDF without requirement of additional computer.0.2 Micron Air Filter Provider for Vacuum break.To prevent the cross-flow of air between the clean and unclean area, a contamination seal is provided.To insert the temperature sensors, validation ports are provided.In-Situation Filter Sterilization Cycle(Optional).

Product Details:

Ribbon Blender manufactured by Neelam industries are the most versatile and flexible designed to meet the widest requirements of the Pharmaceutical Industry.Application Areas :PharmaceuticalDyesChemicalsFood productsOrganicsPigmentsAgricultural productsMineralsPesticidesOperation :The RIBBON BLENDER is an efficient and versatile blending machine for mixing of dry granules & powders homogeneously. Approximate two third of the volume of the container of Ribbon Blender is filled to ensure proper mixing. The Ribbon Blender gives best result for mixing of dry powder & granules due to the design and shape of the mixing ribbon and product container. It can be used for Pharmaceutical, Food, Chemical and Cosmetic products etc.Material should be charge from the top side. There are port/ports should be provided on the top cover to charge the material as well as for air vent. One discharge valve provided at the bottom side at centre of the container. The discharge height could be adjust as per the requirement, so that material gets discharge in the other container directly, so that material handling time for discharge is nil and the operation is dust free.Ribbon Blender :In Ribbon Blender the powder moves from centre to the end of container and end of container to the centre of container. Hence requirement of total mixing time is very less and the RPM required are also very less.The dry material gets sufficient continuous movement due to the shape & movement of ribbon & shape of the container., which moves material for good quality of blending.The unit is consist of one electrical motor, one worm reduction gear, belt drive between motor and gear, couple drive between gear to ( ribbon ) mixing stirrer. Container having four nos. of legs with discharge valve & top cover. Both end of mixing shaft is sealed with bush & PTFE gland housing & safety guards are provided on all moving parts.Special Features of the Ribbon Blender :The shape of container and mixing stirrer gives sufficient continuous movement to the powder / granules, result in good quality.All contact parts of the Ribbon Blender are made out of SS304/SS316 or SS316 L quality material.Jacket Heating / Cooling facility Provided as optional.Maximum care has been taken to ensure safe operation of the unit.Inching facility for stirrer for discharge of material.Full cover on top side of the container.Discharge height must be adjusted, if confirm with order.Operating panel provided for safe operation of Ribbon Blender.Centrally located material Discharge valve. ( Butter fly / Sliding Valve )Dust proof top cover with window provided.General structure completely made out of mild steel & painted in Standard Model & the same is claded with SS304 in GMP model.Safety Guards & Covers made out of SS304 in GMP Model & made out of mild steel in Standard Model.Legs made out of M.S & painted in Standard Model & same will be claded with SS304 in GMP Model.Panel provided with following facilities in 500 Liters & bigger model of Ribbon Blenders. In Small model of Ribbon Blender - only D.O.L. starter provided for On-Off operation of the motor.Three phase indication facility.D.O.L. starter for on-off operation of motor.Emergency stop provided in panel.Digital timer for batch time setting.Limit switch provided at top cover for safety purpose.Inching push button with selector switch for inching operation during discharge of material.

Product Details:

Neelam Industries offers high-performance Pre Filled Syringes Machines designed for precise, sterile, and reliable syringe filling in the pharmaceutical and healthcare industry. Our machines are engineered with advanced technology to ensure accurate liquid filling, minimal wastage, and complete compliance with international GMP standards.

These syringe filling machines are ideal for vaccines, biotech products, injectable drugs, ophthalmic solutions, and biotech formulations, delivering consistent quality with user-friendly operation. With options for automatic and semi-automatic models, our Pre Filled Syringes Machines guarantee contamination-free processing and enhanced productivity.

Key Features:

• High precision filling with ±1% accuracy

• Compact, GMP-compliant stainless steel design

• Suitable for glass and plastic prefilled syringes

• Automatic filling, stoppering, and sealing systems

• Easy changeover for different syringe sizes

• Low maintenance with long service life

• Available in customized capacities as per client requirement

Applications:

• Pharmaceutical companies

• Biotech and vaccine manufacturers

• Research laboratories

• Contract manufacturing organizations (CMOs)

Neelam Industries’ Pre Filled Syringes Machines are trusted for their efficiency, sterility, and reliability, making them the preferred choice for global pharmaceutical production lines.

Product Details:

Pressure Vessel

APPLICATION :
Pressure vessels are used in the Membrane filtration system. While pressure vessels are used to transfer the product to the filter under Nitrogen pressure, the filling vessels are used to collect the filtered sterile solution. They work as buffer vessels in the product filling room.

Pharmaceuticals

• Sterile Solutions
• Vial
• Ampoules
• I. V. Fluids
• Aerosols
• LVP & SVP Solutions

Biopharmaceuticals

• Vaccines
• Human Insulin
• Serums
• Plasma Fractions
• Bacteria and cell cultures

Other details:

• Top & Bottom Dish Ends
• Jacketed vessels ( Optional)
• Diaphragm type Pressure Gauge.
• Sterile Safety Valve

S.S. 304 Mobile Trolley with PU wheel

• All Connection are t/c End
• Vessels are Autoclaveble
• Vessels are designed accordance with ASME BPE and EHEDG Guidelines

Product Details:

Neelam Industries’ Membrane Filter Holder are decorously designed to support the membranes against the applied pressure differential.

The membrane holders in combination with membrane filter are used for sterile filteration of pharmaceutical and biological solution. The selection of the liquid to be filtered in a dayare supplied with removable legs The filter support screen is offered in two type

• S.S. with polished surface
• S.S. with Teflon coating

The Teflon coated screen is usually preferred to allow autoclaving with a filter assembled in place The inlet and outlet connection are made of sanitary design larger models for easy of cleaning and maintenance all the holders are provided with air vent valve This valve has to be opened in release any air that could be trapped in between and may offer resistance to the flow of the liquid during the process of filteration

The sealing ring can be offered in silicone. Grip knobs are provided to tight the rings. The membrane filter support screen has an under drain support.

A flow deflector under the top plate ensure even distribution of the liquid flow A back pressure support screen may also be supplied as an optional accessory to protect the filter against reverse accidental flow (Always use a pre filter while using back pressure screen).

Product Details:

Pre Filled Syringe Filling Machine

Ready-to-use disposable syringes offer ease of use, security, hygiene and dosing accuracy for medical injections.

Our line allows a combination of filling closing for processing ready-to-use disposable syringes and vials in nests.

Ready-to-use disposable syringes are supplied sterilized and ready to-fill into trays called “Nest”. There is no need for washing and sterilizing the associated components prior to the filling and sealing operation.

The equipment is designed to be used in sterile room applications, in accordance with regulations of the cGMP and USFDA.

Machine sequence of operations :

• Manual or automatic insertion and manual or automatic removal of “Nest”, depending on the machine model.
• Dosing through valveless rotary piston pumps or through peristaltic pumps.
• Automatic infeed and automatic positioning of plunger stoppers / stoppers.

All production parameters are stored in the PLC data memory, through “formats”.Therefore, parameters such as :

• Dose volume.
• Programmable Kinematics of the filling process.
• Positioning depth of the plunger stoppers / stoppers.
• Output speed.

They are adjusted automatically and are associated to each format of syringe or vial processing.

The formats can be recalled from the control panel, re-establishing automatically the ideal predetermined settings. New programs can be created easily and quickly by the user.

The changeover to a different size is carried out quickly, easily and without tools, by exchanging complete sets of format parts.

To work under sterile room applications we offer different laminar flow units enclosures adapted to each size of machine. These optionals guarantee to work under ISO 5 Class.

The unit can be designed to be installed into an isolator when production requirements recommend its use.

Utilities :



In compliance with :

cGMP, GAMP, ISO 9001 : 2008

Product Details:

Vacuum Leak with Dye Ingress for Glass Vial is a leak detection and measurement currently the subject of ever-increasing attention by legislative bodies (environmental, health, etc.). This is resulting in more stringent and definitive standards and specifications.

Technical features: Testing precision, speed, repeatability, silence, user friendliness, cleaning and maintenance simplicity, and low energy consumption.

Our leak testing systems are completed with documentation supporting the qualification in Validation protocol.

APPLICATION :
Pharmaceuticals

• Sterile Solutions
• Vial
• Ampoules
• I. V. Fluids
• Aerosols
• LVP & SVP Solutions

Biopharmaceuticals

• Vaccines
• Human Insulin
• Serums

Other details:

• Completely Automated Process Cycles
• On line display of process parameters with P & I of Operating Systems
• Display of Fault messages
• Supervisory access code prevent unauthorized changes
• Pre Mix Vessel for Mixing of Water with blue dye
• On Line pH, Conductivity sensing to ensure Proper washing
• Vaccum system for Dye Penetration and to ensure no crack on the glass vial / ampoule
• Drying system
• PLC-based, with Touch Screen MMI and SCADA Packages