Services

  • FERMENTA BIOTECH
    Vitamin D3 & Allied Products
  • ENALTECH LABS
    Multi Product Small Scale Production & Kilo Lab
  • CADILA HEALTH CARE LTD.
    Multiproduct Plant API Plant
  • RPG LIFE SCIENCES
    API Facility (Immuno Suppressants)
  • ALMELO PVT. LTD.
    API Plant
  • NAVIN FLUORINE INTERNATIONAL LIMITED
    Multi Product Manufacturing Facility
  • RELIANCE PHARMACEUTICALS
    API Kilo Lab & Steroid Kilo Lab Facility
  • SUVEN LIFE SCIENCES LTD.
    Intermediate Manufacturing Facility

Client Name
Fermenta Biotech

Facility Type
Vitamin D3 & Allied Products Facility

Project Location
Dahej, India

Project Duration
12 Months

Services Provided
  • Master Planning
  • Basic Engineering
  • Detail Engineering
  • Procurement Assistance
  • Site Audits
  • Construction Management
  • Commissioning & Start Up
  • Validation Support
Key Project Features
The scope commenced with Site Master Planning for setting up of blocks for all production stages of Vitamin D3, in phases. The entire project was envisioned to be developed in four phases commencing with setting up of API facility in the first phase with backward integration to Fermentation facility in the fourth phase.

The overall site to be developed is about 28,000 Sq. M. with a total constructed area of 3000 Sq. M. in the first phase. The first phase of the project was completed in 12 months.

Client Name
Enaltec Labs

Facility Type
Multi Product Small Scale production & kilo Lab Facility

Project Location
Ambernath, India

Project Duration
12 Months

USFDA Approved

Services Provided
  • Basic Engineering
  • Detail Engineering
  • Procurement Assistance
  • Inspection & Expediting
  • Construction Management
  • Validation Support
Key Project Features
The facility was designed as a Multi-Product Small Scale Production & Kilo Lab facility for manufacturing APIs.

The proposed facility was planned, designed and engineered as per cGMP standards of international authorities like USFDA, WHO etc. and confirms to all relevant local statuary/regulatory and cGMP requirements. The facility design complies with ICH, NFPA & ISPE guidelines. The facility has eventually received approval by USFDA.

The project comprised of setting up of Production Block, Warehouse & Quality Control Block. In addition, the facility has all necessary ancillary structures like Utility Block, Solvent Drum Yard, Transformer Yard and Effluent treatment plant.

Client Name
Cadila Health care Ltd.

Facility Type
Multiproduct Plant API Plant

Project Location
Ankleshwar, India

Project Duration
12 Months

Services Provided
  • Basic Engineering
  • Detailed Engineering
  • Project Management
Key Project Features
The facility was built in an existing site of Cadila Healthcare in Ankleshwar. The facility was mapped for Omeprazole, Losartan and Amiloride on Campaign basis, with any two products simultaneous manufacturing.

The proposed facility is planned, designed and engineered as per cGMP standards of international authorities like US FDA, WHO, etc. and confirms to all relevant local statuary/ regulatory and cGMP requirements. The facility design complies with ICH, NFPA & ISPE guidelines.

The project includes Intermediate production section with 12 reactors and production capacity of 30 tons per month. Two dedicated final product processing area from crystallizer onwards were planned one above the other due to space constraints at existing location. The typical equipment installed are Reactors, Centrifuges, Agented nutsche filter dryers, Rotary paddle dryer, Rotary double cone vacuum dryer.

Client Name
RPG Life Sciences

Facility Type
API Facility
(Immuno Suppresants)

Project Location
Navi Mumbai, India

Project Duration
12 Months

Services Provided
  • Concept Design
  • Basic Engineering
  • Detail Engineering
  • Procurement Assistance
  • Inspection & Expediation
  • Site Audits
  • Validation Support
  • Commissioning & Start Up
Key Project Features
This API Facility is constructed on an existing site of RPG. Area of production block is approx. 1500 Sq. M. It was completed within 14 months. It is an USFDA approvable facility.

The new facility has two modules, one dedicated for manufacturing Azathioprine, and another for manufacturing multi-products like Haloperidole, Risperidone, Lamotrigine, etc. The project was unique since we had to fit the layout within the working site using existing utilities without any major shutdown except for hook-up.

SPECTRUM planned the layout with central enclosed pipe rack for two modules with service area. This resulted in reduction in total piping and cabling costs. Enclosed systems such as condensers were taken out of reactor area; this resulted in improved clean ability of reaction area. A multi utility header was provided in the service area with pneumatic operations. These valves were interlinked to avoid mix-up of utilities during utility change over.

Client Name
Almelo Pvt. Ltd.

Facility Type
API Plant

Project Location
Telangana

Project Duration
18 Months

Services Provided
  • Concept Design
  • Basic Engineering
  • Detail Engineering
  • Procurement Assistance
  • Project Management
  • Qualification & Documentation Support
Key Project Features
Almelo Pvt. Ltd. is a leading manufacturer of specialty fine chemicals, advanced intermediates and API’s.

API-unit-2 facility at Telangana is a Greenfield facility designed for cGMP compliance. The facility is divided into two trains, Train-1 & Train-2. Each train has 21 Reactors with 400 KL total reactor volume of both train.

The facility has following salient features:
  • Two clean room arrangements
  • Automated bulk packing
  • Segregated plots for warehouse, production plants, ETP, solvent recovery block, admin/QA/QC, tank farm and future expansion

This facility is used for producing intermediates and APIs. The facility has a zero discharge waste treatment system. No steam is utilized inside the process.

The seamless connectivity to other areas improves efficiency and provides cGMP environment for the products being manufactured. The plant is design to manufacture finished product in solid form. All the operations are HMI monitored with DCS controlled and have all the safety interlocks as recommended for the safety.

Client Name
Navin Fluorine International Limited

Facility Type
Multi Product manufacturing Facility

Project Location
Dewas, India

Project Duration
15 Months

Services Provided
  • Project cost estimate
  • Conceptual planning
  • Basic Engineering
  • Detailed Engineering
  • Procurement Assistance
  • Project Management
  • Bill verification
Key Project Features
Navin Fluorine International Limited is part of Arvind Mafatlal group and is a leading manufacturer of fluorinated compound.

New state-of-the-art cGMP compliant plant has been set up in Dewas, India.

The facility has following salient features:
  • 40kl of multi-purpose reactor capacity
  • Expertise in fluorination & high-pressure chemistry
  • World leading technologies in SF4 fluorination
  • Other chemistries include hydrogenation, carbonylation, halogenation and many more
  • Custom synthesis/contract manufacturing

The facility was be designed as multi-product facility to facilitate manufacturing of various product on contract manufacturing. The facility has high pressure hydrogenation and other high pressure reaction area segregate from each other and rest of the plant with reinforced cement concrete wall to minimize the impact due to explosion in case of any accident in these areas.

The plant is design to manufacture finished product as solid as well as in liquid form.

All the operations are DCS controlled and have all the safety interlocks as recommended during HAZOP and pre start up safety review.

Client Name
Reliance Pharmaceuticals

Facility Type
API Kilo Lab & Steroid Kilo Lab Facility

Project Location
Navi Mumbai, India

Project Duration
14 Months

Services Provided
  • Concept Design
  • Basic Engineering
  • Detail Engineering
  • Procurement Assistance
  • Inspection & Expedition
  • Site Audits
  • Commissioning & Start Up
  • Validation Support
Key Project Features
This New API Facility is constructed on an existing site of Reliance. This site is located at M.I.D.C. Rabale, Navi Mumbai. The Facility covered an area of 1400 Sq. Meters. The Project was completed in 14 months.

The building is a ground plus three-storied structure. The ground floor houses kilo labs for General products and Steroids. The first floor serves as service floor to ground floor. The second floor houses a Peptide Lab & QC facilities. The third floor houses a API Research & Development facility.

The unique feature of this facility is that a single fluid heat transfer system is used.

A hydrogenator area is planned within the facility, with a highly automated “HUMAN MACHINE INTERFACE.”

All designs and engineering was completed well ahead of schedule.

Client Name
Suven Life Sciences Ltd.

Facility Type
Intermediate Manufacturing Facility

Project Location
Visakhapatnam, India

Project Duration
18 Months

Services Provided
  • Basic Engineering
  • Detail Engineering
  • Procurement Assistance
Key Project Features
Suven Life Science Ltd. is a leading manufacturer of fine chemicals, advanced intermediates and API’s.

Intermediate manufacturing facility at Visakhapatnam is a Greenfield facility designed for cGMP compliance.

The facility has following salient features:
  • Intermediate production area
  • Distillation section
  • Chlorination processing
  • Two clean room areas for final product processing
  • Automated bulk packing
  • Segregated area for warehouse, utility, production plants, admin/QA/QC, solvent recovery block, solvent tank farm are provided

This facility is used for producing several intermediates and APIs products. The facility utilizes hot oil in the process, the building is built in RCC structure, the material handling is very critical as the volumes are very high, customized design for material handling is done for this project.

The plant is design to manufacture finished product in solid form.

All the operations are HMI monitored with DCS controlled and have all the safety interlocks as recommended for the safety.

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