CRAMS - Laboratories

Navin Fluorine recently expanded with 7000 sq. ft. of newly built, dedicated, energy-efficient, and environmentally friendly laboratory space, with room for further expansion, at the Surat campus in Gujarat, India. The laboratories are modular in design allowing for a greater degree of confidentiality for our clients. Our suite of labs is outfitted with sixteen 8’ fume hoods, and four 10’ walk-in hoods.

Capabilities include:

• High Pressure Labs.
• HF-Labs.
• Pilot Plant.
• cGMP.

In-House Equipment Includes:

• LC-MS
• GC-MS
• HPLC
• UV-spectrophotometer
• FTIR
• Jacketed glass reactors
• Cryogenic apparatus
• Lyophilizer
• Inconel/Hastelloy
• Hydrogenation apparatus

Next-day and same day reporting services are available from NMR facilities and other advanced analytical services at nearby institutions and contract analytical service providers.

We have licenses for reaction searching via web-based chemistry database consisting of reaction and synthesis information, as well as bibliographic data. We have subscriptions to most of the journals of importance from Science direct and ACS.

Pilot plants:

The Navin Fluorine pilot plants are fully established to handle your scale-up challenges. The pilot plants are DCS controlled and have their own separate heating and cooling systems. Reactors with required materials of construction (MSGLR, SS316 and Inconel) and different sizes (100-500L) provide diverse capabilities to our operations. SS 316 autoclaves (250L) for performing high pressure (up to 30kgs/cm2) and high temperature (up to 250°C) reactions are also available. The Navin Fluorine pilot plants specialize in fractional distillations and have several specialized structured packing available to separate products as close boiling as 2 degrees.

Navin Fluorine pilot plants have the ability to fill the gap between kilo lab and commercial production, both for cGMP or non-GMP applications. They’re also heavily involved in developing and improving manufacturing processes for products destined for commercial-scale production. Our laboratories are equipped to handle nearly any chemical reaction that might be requested for synthesis of new substances and route development. Manufacturing quantities range from a few grams to multiple kilograms produced according to cGMP standards or non GMP as needed.

We feature cGMP pilot plant production in Dewas (Madyapradesh), as well as non-GMP pilot plants and full commercial production facilities in Surat (Gujarat). We have the facilities and expertise to help you with product development at every stage, from contract research through commercial manufacturing.

It’s a talented, fast, and responsive team with an exceptional focus on solving customer problems. Our growing R&D team members with their many years of experience in handling Fluorochemicals are constantly working with the manufacturing team to introduce new products, and also work with our valued customers to address their needs in a timely and cost efficient manner. We will help you control development time and costs by thoroughly testing your process in research laboratories featuring state-of-the-art NMR, FTIR, UV/VIS, ICP, GC, HPLC, Mass spectrometry and other equipment.

We are committed to being your long-term, low-cost service partner, and dedicated to your success. Contact us today to see how we can give you priority attention that most others simply can’t match.

Facility details:

The pilot plant consists of a chemistry processing area built as an RCC structured three story building. The chemistry area is 1970 sq. m (reaction area is 1170 sq. m and powder processing area is 560 sq. m) consisting of glass lined reactors, stainless steel reactors, Inconel-600 reactors, Hastalloy C276 reactors and separate hydrogenation reactors with all the supporting equipment such as measuring tanks, receiving tanks, heat exchangers, storage tanks, centrifuges, tray driers, ne vacuum drier, Millers and sifters etc. The area is well ventilated and spacious for free movement of materials.

The reaction vessels and other accessories are mounted on properly designed structures. All service lines like steam, vacuum, brine, Nitrogen, CT Water, hot oil, chilled water, hot water, 1 Torr vacuum system, 4 Torr vacuum system, process water and compressed air are provided to this pilot plant on block by drawing individual service lines from the main branch, and return lines are provided to each service station. The block is provided with flameproof light fittings. Adequate airflow is provided. All the equipment and other accessories are properly grounded for the discharge of static electricity against shock, sparks and lightning. Various drain lines are provided for floor wash water collection and effluent water collection. Scrubbers are provided to scrub the gases.

The Navin Fluorine API/Advance Intermediates manufacturing facility in DEWAS is situated approximately seven (7) Km from the main City Bus Stand and nine (9) Km from the western Railway’s junction DEWAS.

The main objective of this facility is to manufacture and process customer oriented products under the “Arvind Mafatlal Groups” Navin Fluorine CRAMS (Custom Research And Manufacturing Services) business, which caters to the supply of such products to different regulated markets in Europe and the Americas for over 100 countries on several continents.

The manufacturing activities at the DEWAS site support systems include:

UTILTITY BLOCK:

There are separate utility facilities for Steam, Brine, Air, Chilled water, Hot water, Hot Oil and Vacuum and also separate diesel generators set to backup in case of power failures.

This utility block has the following train of equipment:

Boiler Unit:
700 Kg steam per hour generation capacity is installed to supply steam for the purpose of maintaining high temperature during chemical reactions, drying and for other unit operations such as distillation, evaporation etc.

Chilling plant:
A chilling plant is provided which chills the cooling medium brine, which is available throughout the plant to provide cooling as necessary. The total chilling capacity is 30 TR.

Compressed Air:
A compressor is provided to supply compressed air to all points in the process area. Compressed air is also used to transfer liquids.

Hot Oil Circulation:
Two hot oil circulation units are provided, each with a capacity of 30,000 Kcal/hour.

Plant vacuum:
Two units are provided to supply vacuum of around 500 mmHg throughout the plant. The vacuum is used to transfer liquids, for vacuum distillation and other purposes.

1 Torr & 4 Torr vacuum:
1 Torr and 4 torr units are provided to supply vacuum. The vacuum is used to high vacuum distillation and other purposes.

Liquid Nitrogen:
Two liquid nitrogen units each have a storage capacity of 1500 lit. These are designed provide temperature control to -120°C.

Room Temperature water:
The water is at room temperature and is used for cooling purposes in heat exchangers, reactors, distillation and drying purposes, etc.

Stand by power:
A separate generator room is provided in the plant. The plant is equipped with 600 KVA generator running on diesel fuel to provide standby power in case of a failure in the power supply. All generators are installed as per the Government standards.

Lighting:
All blocks are provided with adequate lighting as per the norms of Electrical Inspectorate. The entire plant is well illuminated and emergency lights are provided at certain points in case of power failure.

Ventilation and Air filtration:
The main plant is well ventilated, ensuring the availability of fresh air in the working area. Exhaust fans at necessary places are provided to suck the fumes, vapor. The finished product manufacturing areas and handling areas are maintained with clean filtered air. Powerful exhaust fans are provided for proper ventilation.

Emergency shower and locker facilities:
Washing facilities and emergency showers are provided for employees and are maintained properly. Clean and good sanitary conditions are maintained.

Equipment maintenance and calibration:
The equipment in the plant is monitored by the maintenance personnel. A preventive maintenance program is in operation in the plant.

GMP KILO LAB:
The Navin Fluorine Dewas Kilo Lab is a GMP manufacturing unit with the purpose of carrying out scale up of APIs and chemical development studies under Custom Synthesis agreements with Navin Fluorine clients. This is the perfect GMP manufacturing unit to produce small volumes of those API's which are new chemical entities (NCE) devoted to clinical trials.

GOOD MANUFACTURING PRACTICES FOR API PRODUCTS:
There are quality systems in place that address GMP compliance at the site to ensure that the products are consistently produced and controlled to the GMP standards. There is a centralized QA Department for looking after the manufacturing operations and the QA personnel are very strongly involved in all the production activities. There are good line clearance systems in different production steps, and detailed checklists are used for the line clearance in packaging operations.

ACTIVE PHARMACEUTICAL INGREDIENTS PLANT FACILITY:
As a backward integration to the Formulation Division, a separate API Pilot Plant is commissioned in same premises adjacent to the Kilo Lab having their own utility and raw material storage facilities.

The API production Pilot Plant is divided in four parts, a Kilo Lab, a Chemical Area, a Clean Area (I and II) and an Hydrogenation area. The lab area is provided with once through filtered air while the production area is provided with once through filtered air-conditioned air. The plant is equipped with a train of ultra-modern/latest model of process equipment. A summary of the pilot and commercial production capability is provided below:

• SS-316 Reactors.
• MS Glass Lined Reactors (capacity 100 L to 500 L).
• SS Glass Lined Reactors (capacity from 100 L to 500 L)
• SS-316, SS-304 (Halar coated) and MS Rubber Lined Centrifuges having capacities of 24” each.
• Tray Driers, Vacuum Tray Driers
• Leaf Filters, Pressure Nutche Filters & sparkler Filters.
• In our Clean area, we have equipment for handling finished products including Multi Mills, Triple Deck Sifters, an Octagonal Blender and Packing area. Clean Area is also has separate storage facilities to store materials at different stages.
• Store Rooms (2 Nos.) for storage of Finish Goods, out of which one is air-conditioned.
• A separate Kilo Lab area(Process Development Lab) is available for backup of our production department. It has 3 Nos. of Glass Distillation Assemblies ( 10 Ltrs, 20 Ltrs and 50 Ltrs.) respectively to carry out production of such products required for High vacuum Distillation for carrying out distillation with different fractions of API in small batch sizes.

In addition, the facility is capable of successfully delivering highly critical catalytic reactions which are often the core of various process synthesis.

GMP Fluorination:
Under a GMP environment, due to the highly corrosive nature of fluorination chemistry and reagents, the vessels are designed and constructed specifically for the purposes of the reaction requirements and are dedicated for HF reactions. All manufacturing processes using HF are capable of being carried out in the Dewas cGMP facility.

Equipment for other critical unit processes include:
Cryogenics:
The route of synthesis for many products can includes reactions at low temperatures. The requirement for low temperature may be to generate and stabilize transient reactive intermediates, avoid undesired side reactions, and promote stereo selectivity.

Hydrogenation:
The route of synthesis of many products includes a step of catalytic hydrogenation. Our facility is capable in developing Hydrogenation processes using catalysts like (Pd/C, Rh/C, PtO2). The hydrogenation area is equipped with high pressure autoclaves capable of handling pressure reactions up to 35 Kg/cm2, with a working capacity of 100 L.

Maintenance and Service of Equipment:

• Preventive maintenance.
• Breakdown maintenance and failure analysis.
• Machinery modification.
• System validation.
• Instrument calibration.

Safety and Environmental Protection Facilities:

• Effluent Treatment Plant.
• Gas scrubber.
• Dust collectors.
• Fire hydrants and extinguishers.
• Personnel protective accessories.

CRAMS - Our capabilities:
Navin Fluorine has successfully produced many novel targets for our clients in a timely and cost effective manner. Production may be initially only gram quantities before we develop the product into kilo quantities and beyond.

Navin Fluorine has the technology available to run the majority of classical and modern reactions recognized in the literature today, in addition to its own fluorination methods for the production of some intermediates. This allows Navin Fluorine to provide an impressively diverse range of useful intermediates for the organic chemist from pharma, agro, and biotech to electronic industries.

CRAMS - Reaction types

Acylation Alkylation Schiemann Balz-Schiemann Bromination Chlorination Chloromethylation Condensation Cryogenic reactions (-780C) Dehydrobromination Diazotisation Diels-Alder reaction Friedel-Crafts reaction

Grignard reaction Halex reaction Hofmann degration Hydrobromination Methylation Michael addition Nitration Reductions Sulfonation Sulfoxidation Thiolation Wolf-Kishner