Services

  • GLENMARK GENERICS LTD.
    Solid Oral Facility
  • GLENMARK PHARMACEUTICALS LTD.
    Metered Dosage Inhalers
  • M J BIOPHARM
    Insulin Injectables, Oral Solids & Cephalosporine Powder Injectables Facility
  • AUROBINDO PHARMACEUTICALS LTD.
    Solid Oral & Liquid Oral Facility
  • SANZYME LTD.
    Injectable (Hormones) Facility
  • NOVAST LABORATORIES LTD.
    Oral Solids Facility (General & Oncology)
  • KUSUMPHARM
    Oral Solid Facility
  • EASTPHARM
    Large Volume Parenterals

Client Name
Glenmark Generics Ltd.

Facility Type
Solid Oral Facility

Project Location
Goa, India

Project Duration
months (Phase wise Expansion)

Services Provided
  • Basic Engineering
  • Detail Engineering
  • Commissioning & Start Up
Key Project Features
This US FDA approved facility has a total built up area of 14800 Sq .M. comprising of a utility block and main manufacturing block complete with processing areas, quality control laboratory, warehouse, personnel gowning areas and service areas for air handling units and purified water generation and distribution system. This facility was constructed in a phase-wise manner over a period of 24 months.

The facility has five lines for manufacture of Tablets. Each line comprises of multiple suites for granulation, drying, blending, compression, and coating. The facility has a central packing area with provision for blister (Alu-PVC, Alu-Alu), and Bulk Packing.

The construction activities during the expansions were planned in such a manner that at no time there was stoppage of production. Necessary measures to minimize the interference with the ongoing operations were adopted.

Client Name
Glenmark Pharmaceuticals Ltd.

Facility Type
Metered Dose Inhalers

Project Location
Baddi, India

Project Duration
months (Phase wise Expansion)

Services Provided
  • Concept Design
  • Basic Engineering
  • Detail Engineering
  • Procurement Assistance
  • Construction Management
  • Commissioning & Start Up

Key Project Features
The facility is designed to produce 'Metered Dose Inhalers' and has a total built up area of about 3500 Sq. M. The main block is designed as a three floor structure and houses Production area, Stores, Personnel Gowning areas and a compact Quality Control section.

The MDI Filling line has been procured from DH Industries (Pamasol), UK. The line has an arrangement for single and double stage propellant filling of containers. HFA 134a will be used as propellant.

SPECTRUM was involved in developing Process P&IDs including P&IDs for transfer of pressurized HFA, URS for Process Vessels and in the process has gained valuable exposure to special design requirements of such facilities. The layout is planned in a manner so as to enable modular expansion of the facility to accommodate second filling line in future.

Client Name
M J Biopharm

Facility Type
Insulin Injectables, Oral Solids & Cephalosporine Powder Injectable Facility

Project Location
Navi Mumbai, India

Project Duration
months (Phase wise Expansion)

Services Provided
  • Concept Design
  • Basic Engineering
  • Detail Engineering
  • Procurement Assistance
  • Validation Support

Key Project Features
The facility was built with technical support of Eli-Lily, USA. SPECTRUM's personnel visited US plant of Eli-Lily to understand manufacturing operations prior to design of the facility.

The entire development comprises of 3 separate buildings spread over 25000 Sq. M. of plot with the main block housing manufacturing sections for Insulin Injectables. The Cephalosporine Dry Powder Injectables are produced in a dedicated block and houses its own manufacturing, warehousing and personnel gowning sections.

Built in a time span of 18 months, this Facility is approved by UK MHRA, South African MCC, Brazil ANVISA.

Client Name
Aurobindo Pharmaceuticals Ltd.

Facility Type
Solid Oral & Liquid Oral Facility

Project Location
Hyderabad, India

Project Duration
months (Phase wise Expansion)

Services Provided
  • Concept Design
  • Basic Engineering
  • Detail Engineering
  • Procurement Assistance
  • Site Audits
  • Commissioning & Start Up

Key Project Features
This US FDA approved facility was built on a green-field site. The facility comprises of two four-storey blocks built adjacent to each other and interconnected through corridors on each floor.

The total constructed area of the production blocks is 26000 sq meters inclusive of Warehouse and personnel gowning areas. The facility was built in a time span of 18 months. The blocks have manufacturing sections for three finished dosage forms viz. Tablets, Dry Powder Suspensions and Liquid Syrup Suspensions.

The manufacturing section comprise of 7 Granulation suites, 8 Tablet Compression suites, 7 Coating suites, 6 Packing lines, 1 line for Dry Syrups and 1 line for Liquid Syrups. Facility designed as a multistorey facility with intermediate flow of materials by gravity. This allows effective utilization of ground space.


Client Name
Sanzyme Ltd.

Facility Type
Injectable (Hormones) Facility

Project Location
Hyderabad, India

Project Duration
Months (Phase wise Expansion)

Services Provided
  • Concept Design
  • Basic Engineering
  • Detail Engineering
  • Procurement Assistance
  • Construction Management
  • Validation Support

Key Project Features
The facility is designed to meet the regulatory requirements of international bodies such as US FDA, UK MHRA. Spectrum’s scope includes developing Site Plan for phase wise development of the plot, Concept Design of various blocks, Basic & Detailed Engineering, Procurement Assistance and Construction Management.

The entire development comprises of 3 separate blocks spread over 15300 Sq.M. of plot. The structures planned include Injectable Block, Bio Lab, Utility Block, and other ancillaries like Security cabin, Pump rooms, ETP, etc.

The salient design features of the facility include:
  • Combi line (Vial and Ampoule) for Hormonal Injections and with Lyophilization
  • Dedicated Bio Animal Lab planned in the Plot
  • Construction of Process areas with Clean room Modular panels
  • Clean Utility system consists of Purified water, Water for Injection and Pure steam planned for the Injectable plan
  • Effluent deactivation prior to discharge to the main ETP


Client Name
Novast Laboratories Ltd.

Facility Type
Oral Solids Facility
(General & Oncology)

Project Location
Nantong, China

Project Duration
Months (Phase wise Expansion)

Services Provided
  • Concept Design
  • Basic Engineering
  • Detail Engineering
  • Procurement Assistance
  • Construction Supervision
  • Documentation & Validation Support

Key Project Features
The project involves setting up two separate blocks for producing Oral Solid Dosage formulations for General and Oncology category of products. The overall built up area of both the facilities put together will be about 21,000 Sq.M. The annual capacity of the General products facility will be about 2 billion units and that of Oncology products facility will be about 70 million units. The facility will be set up in accordance with regulatory guidelines of US FDA and other local statutory norms for safety and building construction regulation.

The Oncology facility will have its dedicated Stores and Quality Control departments whereas the General products facility will share these services with the other existing blocks. Spectrum on this project will work in coordination with a local design firm who shall be responsible for Structural and Fire Safety designs for the buildings and support Novast in applying and getting required statutory approvals. All the other designs, including development of Conceptual Designs, Product protection strategy, Risk Assessment studies, Detailed Engineering will be performed by Spectrum. Spectrum will depute its resources at site for day-to-day supervision of works at site and also for development of validation documentation and oversee the validation effort.

Expertise of Spectrum will also be utilized in procurement of process equipment for the Oncology facility. The scope shall include development of specifications for equipment with the objective of containment at the source of generation, recommending suppliers, bid evaluation and approval of supplier drawings and documents for fabrication. The operator exposure limit shall be validated for band OEL 4. Most of the equipment will be sourced from Europe. The AHUs will have bag-in bag-out filters and the effluent will be decontaminated before being released to the central ETP.


Client Name
KusumPharm

Facility Type
Oral Solid Facility

Project Location
Sumy, Ukraine

Project Duration
Months (Phase wise Expansion)

Services Provided
  • Concept Design
  • Basic Engineering
  • Detail Engineering
  • Procurement Assistance
  • Construction Supervision
  • Commissioning Support
  • Documentation & Validation Support

Key Project Features
The facility was set up to produce Oral Solids & Liquids in the scenic city of Sumy, Ukraine. The dosages produced include Tablets, Capsules, Liquid Syrups & Suspension.

The facility was set up in an existing building which was renovated. With an overall built up area of 4,500 Sq.M, the building houses Production area, Packaging area, Warehouse, Personnel Gowning areas. Attached to the main block is annex building which houses Quality Assurance, Quality Control, Formulation Development & Administration departments.

Spectrum was involved in developing User Requirement Specification and Procurement of all Production equipment and systems. Production equipment, Clean room panels, HVAC items, Hi-Purity water generation and distribution systems have been supplied from India to reduce the project cost.


Client Name
EastPharm

Facility Type
Large Volume Parenterals

Project Location
Vladivostok, Russia

Project Duration
Months (Phase wise Expansion)

Services Provided
  • Concept Design
  • Basic Engineering
  • Detail Engineering
  • Procurement Assistance
  • Construction Management
  • Validation Assistance
  • Production Technology, Training

Key Project Features
The project involved setting up facility for producing Large Volume Parenterals and associated testing laboratories at Vladvostok in Russia. The facility was planned in accordance to cGMP requirements of WHO.

Spectrum was involved in sizing and selection of process equipment’s and Spectrum’s scope included developing concept designs, basic engineering and detailed engineering of Civil, Clean room modular panels, HVAC, Process Equipment’s, Utilities, Purified Water, WFI, Pure Steam, Electrical, Piping, Plumbing and ETP systems.

Systems such as Modular Clean room panels, HVAC, Process Equipment’s, Generation and Distribution systems for Purified Water, WFI, and Pure Steam were supplied from India.

Unique feature of engineering was design of HVAC systems for sub-zero temperatures of up to (– 32) deg.C. This required Humidification as the humidity levels would fall to very low levels during winters.

Phase I of project was completed in a time span of 22 Months and include installation of machine from Rommelag with annual output 12 Million bottles per annum of 500 ml fill volume.

Phase II of project was completed in a time span of 14 Months and include installation of machine from Rommelag with annual output 8 Million bottles per annum of 100 ml fill volume.

The facility is designed to meet the regulatory requirements of international bodies such as EU, PIC/S.
  • The facility was planned in accordance to cGMP requirements of WHO
  • Engineering was design of HVAC systems for sub-zero temperatures of up to (– 32) deg.C

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