Services

  • SHILPA MEDICARE LTD. (Raichem LifeSciences)
    Solid Oral & Injectable Facility
  • GLENMARK GENERICS LTD.
    Liquid & Freeze Dried Injectable Facility
  • DR. REDDY'S LABORATORIES (DRL)
    API Facility (Hormones)
  • EMCURE PHARMACEUTICAL LTD.
    API-5 Expansion Facility
  • GLENMARK GENERICS LTD.
    Solid Oral Facility (Hormones)
  • DR. REDDY’S LABORATORIES LTD.
    Oncology Facility (Anti-Cancer)
  • NAPROD LIFE SCIENCES PVT. LTD.
    Solid Orals & Injectable Facility
  • MAC-CHEM PRODUCTS (I) PVT. LTD.
    API Multi Product Facility

Client Name
Shilpa Medicare Ltd. (Raichem LifeSciences)

Facility Type
Solid Oral & Injectable Facility (Oncology)

Project Location
Hyderabad, India

Project Duration
months (Phase wise Expansion)

Services Provided
  • Concept Design
  • Basic Engineering
  • Detail Engineering
  • Containment Strategies
  • Procurement Assistance
  • Construction Management
Key Project Features
The facility is designed to meet the regulatory requirements of international bodies such as US FDA, UK MHRA, Australian TGA, Brazilian ANVISA, PMDA Japan. The entire development comprises of 7 separate blocks spread over 27000 Sq. M. of plot. The structures planned include Oral Solids block, Injectable Block, R & D Block, Quality Control & Quality Assurance Block, Administration Block, Canteen, Utility Block, and other ancillaries like Security cabin, Pump rooms, ETP, etc.

Client Name
Glenmark Generics Ltd.

Facility Type
Liquid & Freeze Dried Injectable Facility (Oncology)

Project Location
Pilar, Argentina

Project Duration
months (Phase wise Expansion)

Services Provided
  • Concept Design
  • Basic Engineering
  • Detail Engineering
  • Procurement Assistance
  • Construction Management
  • Commissioning & Start Up
  • Validation Support
Key Project Features
The facility was designed to produce Liquid and Freeze Dried Oncology Injectables. The facility was designed on a green-field site of about 10000 Sq. M. The main block is designed as a two storey building with Production area, Warehouse, Personnel Gowning areas housed on the Ground Floor and the Quality Assurance and Quality Control sections
housed on the First Floor.

The Vial Filling line and Freeze Drier have been procured from leading manufacturers in Europe. Clean room panels, HVAC items, Hi-Purity water generation and distribution systems and other process equipments have been supplied from India to reduce the project cost.

The AHUs have Bag-In Bag-Out type filter arrangement to avoid exposure of operator to potent dust while replacing the filter. The process effluents generated are first deactivated and then released into the main effluent treatment plant. The exhaust air from various systems is filtered thru ULPA filters prior to release in to the atmosphere.

Client Name
Dr. Reddy's Laboratories (DRL)

Facility Type
API Facility (Hormones)

Project Location
Vizag, India

Project Duration
months (Phase wise Expansion)

Services Provided
  • Concept Design
  • Basic Engineering
  • Detail Engineering
  • Procurement Assistance
  • Site Supervision
  • Commissioning & Start up
  • Validation & Documentation Support
Key Project Features
The Hormone Manufacturing facility was constructed on an existing site of DRL. Area of production block is approx. 1500 Sq. M with a capacity of 50 Kg/ month. The project cost was completed in 10 months.

The facility has two dedicated self-contained modules for manufacturing two products simultaneously. The facility was design for PBOEL (Performance Based Operator Exposure Limit) of 500 mg/cum. Based on this risk assessment Containment levels were decided. Dedicated detoxification reactor is provided to detoxify the effluent before discharging it to a common Effluent Treatment Plant.

SPECTRUM provided critical inputs during planning stage to minimize handling of potent product in powder form. The risk elimination at source technique was used minimizing operator interface. This facility has been approved by USFDA.

Client Name
Emcure Pharmaceutical Ltd.

Facility Type
API-5 Expansion Facility

Project Location
Kurkumbh, Pune, India

Project Duration
Months (Phase Wise Expansion)

Services Provided
  • Concept Design
  • Basic Engineering
  • Detail Engineering
  • Procurement Assistance
Key Project Features
Emcure Pharmaceutical Ltd. is a leading manufacturer of several API’s and formulations. API-5 expansion facility at Kurkumbh is designed for cGMP compliance. The facility includes following processing area.
  • Cytotoxic intermediate processing
  • Non-Cytotoxic intermediate processing
  • Kilo Lab
  • Hydrogenation facility
  • Two clean room crystallization and powder processing zones for Cytotoxic

This facility is designed for producing Oncology APIs.

The facility has high pressure hydrogenation area with in the plant, segregated from other areas with RCC walls & airlock. The peripheral wall and the roof of hydrogenation area is weak to avoid impact in case of accidents, on the other processing areas. The seamless connectivity of all the areas improves efficiency.

The processing of cytotoxic material is done under isolators for safety of the operators & products.

It also provides cGMP environment for the intermediates being manufactured.

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

All the operations are controlled locally with the use of panels and have all the safety interlocks as recommended for the safety.

Client Name
Glenmark Generics Ltd.

Facility Type
Solid Oral Facility (Hormones)

Project Location
Goa, India

Project Duration
10 Months

Services Provided
  • Concept Design
  • Basic Engineering
  • Detail Engineering
  • Procurement Assistance
  • Construction Management
  • Commissioning & Start Up
  • Validation Support
Key Project Features
The facility was built on a green-field site and comprised of two-storey production block along with other ancillary blocks.

The production block has a pilot plant and a commercial scale manufacturing section for hormones in Tablet Form. The total built up area of the is 4830 sq. meters which houses pilot plant, commercial scale manufacturing section, packaging section, warehouse, personnel gowning areas, technical area for AHUs and routing of services, Quality control laboratories and administration offices.

In addition to Production Block, other ancillary block include utility block, electrical panel room, HT and LT yard, ETP area, fuel storage area, scrap yard and security cabins.

The facility was built in a time frame of 10 months. Spectrum's scope of services included Concept Design, Detail Engineering, Procurement Assistance, Site Management, Commissioning and Start Up.

The plant was designed with a prime emphasis on product, personal & environmental safety. Layout was prepared to allow unidirectional movement of material and personnel and minimize potential mix-ups. The main manufacturing areas were maintained at negative pressure with respect to peripheral socially clean corridor.


Client Name
Dr. Reddy’s Laboratories Ltd.

Facility Type
Oncology facility
(Anti-Cancer)

Project Location
Hyderabad, India

Project Duration
10 Months

Services Provided
  • Concept Design
  • Basic Engineering
  • Detail Engineering
  • Procurement Assistance
  • Site Supervision
  • Commissioning & Start Up
  • Validation Support
Key Project Features
The Oncology facility was constructed with an area of production block of approx. 1000 Sq.M. The project was completed in 10 months duration.

This facility of G+1 structure was planned to set up for manufacturing Oncology product with the future feasibility to scale up 10 times greater volume of reactor.

Containment measures such as isolators were used during handling of potent material in powder form.

Special measures such as deactivation of potent liquid waste prior to discharge in to the main ETP and filtration of exhaust air thru ULPA filters were employed.

This facility has been approved by USFDA.

Client Name
Naprod Life Sciences Pvt. Ltd.

Facility Type
Solid Orals & Injectable Facility (Oncology)

Project Location
Tarapur, India

Project Duration
months (Phase wise Expansion)

Services Provided
  • Concept Design
  • Basic Engineering
  • Detail Engineering
  • Validation Support
Key Project Features
The facility comprised of a compact manufacturing block with Dispensing and Manufacturing areas admeasuring only 1000 Sq. M. The facility has received ANVISA approval.

The production block has manufacturing sections for Freeze-Dried Injectables and Oral Solids in the form of Tablets and Capsules.

Dispensing of Actives and Solution Compounding for Injectables is done inside Isolators. Personnel Protective Gowns are planned for personnel working in other parts of the manufacturing areas where they handle potent material. The main manufacturing areas were maintained at negative pressure with respect to peripheral socially clean corridor. The process effluents generated are first deactivated and then released into the main effluent treatment plant.

Client Name
Mac-Chem Products (I) Pvt. Ltd.

Facility Type
API Multi Product Facility

Project Location
Tarapur, India

Project Duration
18 Months

Services Provided
  • Concept Design
  • Basic Engineering
  • Detail Engineering
  • Procurement Assistance
  • Site Supervision
  • Commissioning & Start Up
  • Validation Support
Key Project Features
This API Manufacturing Facility is constructed on green field site at Tarapur. The facility has three modules for manufacturing general products, steroid & oncology. At present two modules are constructed & the other modules will be constructed in future.

The production area layout is planned considering men & material movement as well as intermediate stages in the process. Service area for pipe rack is planned in the central area of all three modules. Condensers are planned on mezzanine & receivers just below them in the production area itself. A multi utility manifold for each reactor & condenser is provided in the service area with pneumatic operations. These valves are interlinked to avoid mix-up of utilities during utility change over.

Dedicated utility block is planned, in addition the warehouse, Admin & QC is also planned within the plant building.

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