Selected Pharma+Biotech Projects
The result of: integrated engineering, excellent technological competence, reliable project management and many years of experience.
We develop, plan and implement optimal, customized solutions.
We have compiled examples of our pharmaceutical and biotechnology projects for you here. This selection shows international projects with various planning tasks for greenfield, brownfield, modernization, GMP upgrades and site expansions.
You will find various service packages such as feasibility studies, concept studies, basic engineering, detail engineering, project management, scheduling, qualification, purchasing, assembly, delivery, expediting, EPC, EPCM, general planning.
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We take non-disclosure contracts and other confidential agreements very seriously. You are therefore only seeing a selection of our customer references. We trust you will understand that we cannot show all the details.
(PN 2039)
New production plant for the manufacturing of effect pigments for cosmetics, Merck, 2023, Germany
- Dryflux technology works on the basis of chemical vapour deposition (CVD). In this scale it is a completely new CVD process for cohesive cosmetic pigments which are used directly on human skin.
- Scope of our services: Development of the customized plant technology for Merck. Installation of the entire process line at the Glatt Technology Centre. The plant is owned by Merck, but operated on-site by Glatt. Glatt act as a contract manufacturer of Ronaflux® pigments for Merck.
(PN 2178)
A multi-product, industrial scale fermentation production platform for non-animal derived foods will be created for planetary SA, 2023, Switzerland
- Planetary SA had started the engineering phase of its first industrial scale bio- and food tech production hub in Switzerland. Glatt and IE Group were commissioned to plan the world’s first integrated precision and mycelium fermentation protein plant.
- Scope of our services: Concept and Pre-Basic. Planning the process technology systems, including media supply, process control and automation, as well as the plant safety technology. The planning team, led by Glatt, used an integrated engineering approach, applying cross-trade 3D CAD planning, coordination and Building Information Modeling (BIM) with a focus on sustainability and resource efficiency. IE Group, Lausanne office designed the building and facility infrastructure.
(PN 2132)
Establishment of a BioCampus MultiPilot for process demonstrations of industrial biotechnology for BioCampus Straubing, 2022, Germany
- Product: food products & platform chemicals
- Technology: various biotechnology processes (HACCP / FAMI-QS)
- Scope of our services and supply: Basic engineering for a multi-purpose demonstration facility: mass balances, occupancy plans, design of machinery and equipment, process flow diagram, process description, equipment list incl. specifications, HAZID analysis, 3D model, BIM technical coordination, installation planning, piping planning, specifications for power engineering & automation, concepts for logistics, commissioning, maintenance, process control system, wastewater, exhaust air, cost estimation (tendering)
(PN 2105)
New biotechnological multi-purpose pilot/production plant for c-LEcta, 2022, Germany
- Product: enzymes for customers in strictly regulated markets, e. g. food or pharmaceuticals
- Scope of our services and supply: concept planning and pre-basic design for process/biotech, media, HVAC/MEP (mechanical electrical and plumbing), EMSR technology, layout, plant safety, budget requests, cost estimation and scheduling
(PN 2138)
New new pharmaceutical sterile production facility for implants, 2022, Germany
Concept study. Development of GMP layout for a modular construction solution in preparation for moving production with minimum effort including media supply, layout plan, site plan, alternative consideration (lightweight hall), deadline and cost estimate
(PN 2046)
New GMP Biorefinery by NSTDA, 2022, Thailand
- National Science and Technology Development Agency Thailand (NSTDA) is implementing the Government initiative Thailand 4.0 with regard to strategic biotechnology growth hub at Eastern Economic Corridor of Innovation (EECi) in Thailand. One part of the new BIOPOLIS complex is the GMP Biorefinery Pilot Plant at EECi, for which German engineering company Glatt Ingenieurtechnik was selected to provide the engineering services.
- The contract between NSTDA and Glatt comprised Conceptual and Basic Design phase for the GMP Biorefinery.
(PN 1833)
New blood plasma fractionation facility for CSL Behring, 2021, Germany
- Engineering of main process units in cooperation with GP Bideco GmbH including basic design for fractionation, buffers, CIP/SIP and further main process units, specifications and tender documents, detail engineering, supervision of implementation, commissioning and qualification (IQ/OQ)
- Scheduling for the overall project
(PN 2098)
Qualification support for Ever Pharma Jena, 2021, Germany
- Preparation of various qualification and requalification documents
- Preparation of qualification reports
- On-site qualification support
- Products: solid and liquid dosage forms
(PN 2087)
Construction of a new GMP production plant for chemical API for HAPILA GmbH, 2021, Germany
- Preparation of basis documents for a cost estimate (phase 1)
- Concept Design for process, utilities, MEP, Layout, building internal / finishes, electrical, automation,
plant safety, budget inquiries, detailing of cost estimate
(PN 2047)
New European Manufacturing site for API products of YONSUNG Fine Chemicals Co., 2020, Central Europe
- Front End Study for Chemical API Synthesis: Outline of GMP requirements and design principles, process concept, equipment and containment concept, utilities, E&I, layout, MEP, HSE, cost estimate & implementation schedule
- Products: active pharmaceutical ingredients like prostaglandines and small scale oncology APIs
(PN 1950)
New construction (extension) for a biotech production of human vaccines: CMO Project for IDT Biologika, 2019, Germany
- Planning for process equipment, technical coordination, specification/supplier support for process equipment, project management
- Qualification / participation in preparation and implementation of DQ, IQ, OQ, PQ
- Scheduling and resource planning, controlling support
- Product: Active ingredients for viral human vaccines
(PN 1960)
Conversion of a 3-stage active ingredient synthesis in an existing building of Herbrand Pharma Chemicals, 2018, Germany
- Concept redesign of the synthesis processes including a GMP handling and containment concept
- Layout optimization in the existing building
- HVAC, clean rooms and media
- Preparation for approval planning
- Product: Active pharmaceutical ingredients (API) from chemical syntheses
(PN 1919)
New plant for the synthesis of chemical API integration in existing building of Arevipharma, 2018, Germany
- Consulting services with workshops
- Preparation of feasibility study: process flow diagrams, main equipment list, draft of plant layout, GMP requirements, utility list etc.
- Cost estimation and time schedule for engineering and implementation
- Product: Chemical API, OEB-Level 5 (OEL < 1 µg/m³)
- Technology: Multilevel chemical synthesis in pilot scale
(PN 1850)
Extension of an existing filling line for IDT Biologika, 2018, Germany
- Planning as subcontractor of Bideco Bio- und Pharmasysteme GmbH: takeover of the packages autoclaves and service stations for the new bulk mixing rooms with regard to technical support, coordination of implementation and qualification
- Liquid dosage forms
- Project: Expansion an of existing filling line by 2 freeze dryers incl. loading/unloading systems and additional isolator segment, expansion of 2 further bulk mixing rooms
- Extension to the existing building with the filling line for the bulk mixing rooms, approx. 150 m² footprint, 3 floors
(PN 1871)
New facility for the production of a biotechnological anticancer MAB API product for NOBEL ILAC, 2017, Turkey
- Supplementing of concept design including GMP concept, layout review, optimization of personnel and material flow, calculation of process utilities and utilities for building services systems, HVAC concept, project implementation schedule, cost estimation schedule
- Product: First phase anticancer MAB (API production), next phase compatible products (GMP conform)
- Technology: Wide use of single-use technology (mobile fermenters etc.)
New multi product manufacturing facilities for ACI, 2017, Bangladesh
- Conceptual design
- Process flow optimization
- Basic design for layout for development, safety, cGMP concept
- Detail design
- Civil, structural & architectural design
- Drawing up of tendering documents, and preparation for awarding of contract
- Validation/qualification documentation including: VMP, MQP, RA (FMEA), DQ, IQ and OQ protocols
- High Potent Blocks (hormone + anti cancer) (solid/sterile) + LVP | SVP | LCO block
- One of the tallest manufacturing buildings in South East Asia ≈ 46 m
(PN 1870)
New OSD production facility for OBL Pharm, 2017, Russia
- Site validation and qualification for the basic design phase, including: GMP gap analysis with a GMP review/ assessment, facility basic design risk assessment (FMEA) incl. process, HVAC, utilities, quality control and warehouse, DQ protocols (DQP)
- Product: Oral solid dosage (OSD) OEL 4
(PN 1869)
Revamp of a pilot plant: modification of module II „Lignocellulose“ for CBP – Fraunhofer, 2017, Germany
- Process scale-up support of: commissioning preparation, pre-commissioning/commissioning, test run phase with client, generation of operation manual, focused on core process
- Product: reactive lignin for lignocellulose from beech wood chips
- Technology: biomass pulping by Organosolv process
(PN 1848)
Revamp and upgrade of a vaccines production area for GSK Biologicals, 2017, Germany
- Re-design of a production support area for aseptic production (including installation of new washing machines and autoclaves)
- Product: Flu vaccines (seasonal flu)
(PN 1828)
Construction of a new production facility for different pharmaceutical dosage forms, 2016, Vietnam
- Conceptual design study in cluding development of site master plan, production layout, HVAC concept, calculation of building utilities, design of utility building and high bay warehouse, cost estimation schedule and project schedule for implementation
- Step by step extension of single building modules
- Products: blood plasma derivates (BF), packaging of HEP-B vaccines (first phase of implementation), later fill & finish of insulin, other vaccines, oral solid dosage forms
(PN 1834)
Construction of a new packaging facility for solid pharmaceutical products, 2016, Germany
- Concept study with focus on site plan development and cost estimation for new construction of packaging, administration, laboratory with penthouse for technology, media center, gate and connection to existing high-bay warehouse, implementation of existing packaging lines (10 pieces)
- New building with 1,1160 m2 production area
- Solid dosage forms (OSD)
(PN 1832)
New production facility for human blood plasma products, 2016, Canada
- Basic engineering focused on P&ID development for: thawing skid, CIP skid, temperature control unit
(PN 1826)
Expansion of an existing pharmaceutical production site for NESHER Pharmaceuticals, 2016, USA
- Preliminary conceptual design study for the new production facility including: production process, capacity calculation, layout development, cGMP philosophy, HVAC & utility systems, personnel/material flow philosophy, cost estimation
- Solid and liquid dosage forms (controlled substances) with a capacity of approx. 3 billion units/year
(PN 1821)
New production facility for human blood plasma products, 2016, Canada
- Process consulting focused on: development and definition of process details, process description, process batch and sequence diagrams, development of P&ID’s, process-design review
- Product: Blood plasma thawing and pooling skid including CIP skid and temperature control unit
(PN 1815)
Construction of a new launch facility for the production of oral insulin, 2016, Denmark
- GMP-consulting focused on material handling and cleaning of production equipment and rooms
- Supported by several expert workshops
- Solid dosage forms (OSD): Solids production, dry mixture, tablets, blister packaging
(PN 1783)
Extension of a pharmaceutical production facility for Al Razi, 2016, Saudi-Arabia
- Complete design & engineering including process engineering, project management, technology and building services, drawing up of tendering documents, and preparation for awarding of contract, qualification/validation services
- Multi dosage forms: solid/semi-solid & oral film with a capacity of 200 million units/a
(PN 1741)
New pharmaceutical production facility for Astra Zeneca, 2016, Russia
- Process engineering including complete design, basic and detail engineering, procurement support, expediting, FAT’s, shipment support, SAT’s
– potent line (OEL-level 1 µg/m³)
– none-potent line - building services/utilities: basic and detail engineering, execution engineering – working design review
- production area: 3,140 m², technical area: 1,900 m², storage area: 1,270 m²
- Solid dosage forms: approx. 1 billion bulk tablets
(PN 1794)
New facility for the production of human blood plasma products for Pharmatec/Biotest, 2015, Germany
- Consulting focused on: process for fractionation and Albumin production, process batch and sequence diagrams, process design review
- Product: Human blood plasma derivates with a capacity of 600,000 l plasma/year
(PN 1771)
Construction of a new oral drug product launch facility for Novo Nordisk, 2015, fictitious
- Development of special parts of a conceptual design including production and packaging areas, clean room design, clean utilities, production building design, assisting in development of Site Master Plan, participation at design and review workshops
- Solid dosage forms (OSD): Solids production, dry mixture, tablets, blister packaging with a capacity of 600 million tablets/year
(PN 1758)
Construction of a new pharmaceutical production facility for solid dosage forms, 2015, Lebanon
- Consulting and conceptual design: design review evaluation of documentation package
- Further development of layout, cGMP concept, HVAC, utilities, clean utilities
- Development of room list, interface list, utility consumption list
- New production complex at a total of 9,000 m2 (at 1,500 m2 footprint)
- Solid dosage forms (OSD) with a capacity of 500 million tablets/year
(PN 1768)
Construction of a packaging hall with high rack warehouse for Ever Pharma Jena, 2015, Germany
- Qualification and validation support (RA, DQ, IQ, OQ, PQ, process validation) for ventilation systems (high rack warehouse, production and packaging hall), cooling chamber, storage for narcotic agents, building services management system, monitoring system, compressed air system with allocation, refrigerators, scales, LF boxes, compounding vessel, receiver tank, autoclaves, crack checker, incubator, LF work benches
- Liquid dosage forms
(PN 1759)
Greenfield-project for a new pharmaceutical production facility for Pascoe, 2014 + 2015, Germany
- inventory + workshop for first conceptual ideas + conceptual design for bulk production and packaging to extend the existing production (03 – 04/2014)
- Adapted conceptual design for a greenfield-project (2015)
- Product: Oral solid forms (OSD) and non-sterile liquids, including homeopathic pre-stages
- Capacities: 380 million tablets/year, 1.3 million sachets/year, 3 million bottles/year
(PN 1757)
New pharmaceutical production facility for PharmFirma Sotex SAO, 2015, Russia
- Conceptual design with integrated laboratory for product development, pilot production, consideration of conditions for granulation using solvents
- New building on an extension area of approx. 1,700 m2
- Solid, liquid and semi-solid dosage forms: tablets, capsules, injection solutions, pre-filled syringes
- Capacities: 1.5 billion tablets/capsules/sachets per year, 4 million soft + liquid forms per year
(PN 1698)
New blood plasma fractionation facility, 2015, Germany
- Verification of concept design (process) + extended basis design for:
– fractionation process: buffer preparation, storage and distribution; precipitation vessels
– CIP units, clean utilities, clean room interior work
– tender documentation and specification sheets
– cost estimation for GIT’s scope of planning - Blood plasma derivates with capacities of 1.4 million liters blood plasma/year (5,200 liters blood plasma/batch)
(PN 1701)
Integration of a new pharmaceutical production facility in an existing warehouse, 2015, Russia
- Conceptual design
– task development based on information from the licensor of products
– alternative solutions for a flexible extension of the production for further dosage forms inside the building - Integration in an existing warehouse, 3,600 m2
- Liquid dosage forms: sterile solutions in vials and pre-filled syringes with capacities of 0.7 million vials/year and 0.1 million syringes/year
(PN 1738)
Extension/modernization of an existing OSD plant, 2014, Germany
- Consulting and feasibility study for the integration of additional process equipment into an existing building:
– layout
– arrangement conceptions
– comparison of layout alternatives (options) - Solid dosage forms (OSD)
(PN 1737)
Construction of a new oral drug product launch facility for Novo Nordisk, 2014, fictitious
- Development of a conceptual brief focused on production process and material transfer, comparison of alternatives for material flow, GMP considerations, equipment layout, cost estimation and time schedule
- More level building complex of 12,800 m2 for bulk production, packaging , QC lab, QA, warehouse, administration
- Solid dosage forms (OSD): solids, production of dry mixture, blister packaging with a capacity of 600 million tablets per year
(PN 1725)
Construction of a new pharmaceutical production facility for AlMashriq Pharma, 2014, Saudi-Arabia
- Conceptual design & extended basic engineering: process engineering, QC Lab, R&D block, project management, technology and building services, drawing up of tendering documents, and preparation for awarding of contract, qualification/validation services
- Building: approx. 15,000 m² floor area
- Multi dosage forms: oral solid, semi-solid and high potent oral solid dosage forms with acapacity of 2 billion units per year (tablets & capsules)
(PN 1716)
Construction of a new production facility for LEK, 2014, Slovenia
- Preliminary conceptual design, development and evaluation of layout alternatives including: process design and dimensioning, layout, cGMP concept, HVAC, warehousing, calculation of equipment & personnel, cost estimation
- New building for production and storage
- Solid sosage forms (OSD): 6 billion tablets/year
(PN 1710)
Construction of a new production facility for solids, 2014, Germany
- Conceptual design:
– development of layout, personnel and material flow
– design of main equipment and media supply
– cost estimation - Prodution of granules, pellets, powder for solid dosage forms, food and feed ingredients as well as dietary feed
(PN 1699)
Construction of a new pharmaceutical production facility for RENEWAL („PFK Obnovlenie“ SAO), 2014, Novosibirsk, Russian Federation
- Conceptual design for the new construction complex including options for further extensions: cGMP concept, investment costs +/- 20%, architecture, process technology, utilities, HVAC, warehouse/logistics, personnel
- New building complex for production, packaging, storage, laboratory, administration
- Solid dosage forms (OSD): tablets, capsules with a capacity of 1 billion units/year
(PN 1573)
Extension of a pharmaceutical production site for Endokrin Moscow, 2014, Russian Federation
- Conceptual design, general planning ad authority engineering
- New production and storage facilities by extension (13.000 m³) of the existing production area
- Solid dosage forms (OSD): tablets, capsules with a capacity of 1.4 billion units/year in blisters and stripes
(PN 1662)
Modification of an existing production facility into a specialized production plant, 2013, Germany
- Inventory, consulting and detail engineering:
– Analysis of the existing building, the existing as-built-documentation and existing equipment
– Layout and development of 3D-modell
– Consulting to R&I, P&ID revision
– Detail engineering for process equipment and piping - Existing building
- Active pharmaceutical agents (API) in form of powder
(PN 1667)
Construction of a logistics centre with fully automatic high-bay warehouse for Farmak OAO, 2013, Ukraine
- Conceptual design to integrate a ware-house and logistic center in an existing infrastructure with material input and goods issue, central packaging and administration. Ensuring weather-independent internal logistics to several production buildings
- New building for high-bay racking with logistic center and office complex, total area ca. 16,000 m², building volume: ca. 126.500 m³
- Various material for pharmaceutical production with a capacity of 13,650 pallets, thereof 13,200 high-bay racking; ca. 1200 pallet movements per day; ca. 100 pallets/hour
(PN 1658)
Construction of a new pharmaceutical production facility for PharmaInvest Production, 2013, Algeria
- Conceptual design, process engineering, technical project management for engineering of process technology and building services
- Basic design incl. layout for development, safety and GMP concept
- Detail design, drawing up of tendering documents + preparation for awarding of contract
- Installation supervision
- Solid dosage forms and sterile injectables with a capacity of 500 million units per year
(PN 1652)
New pharmaceutical production facility for parenteral medications for Bayer Healthcare, 2013, Russia
- Conceptual design in cooperation with Bayer Technology Services GmbH: layout, GMP concept, TGA / media supply, adjoining facilities (changing rooms, laundry , etc.), cost estimation
- New constructions of production and warehouse: about 2 levels = 3780 m² with 680 m² of clean room class D/C
- Reconstruction of an existing storage facility, 1 level area = 1570 m²
- Infusion and injection solutions with a capacity of 550,000 bag/year and 450,000 bottles/year
(PN 1611)
Construction of a new pharmaceutical production facility for TOO DOSFARM, 2013, Almaty, Kazakhstan
- Conceptual design and basic engineering for production areas and entire building complex
- Building for production, laboratory, warehouse, administration, media
- Solid and liquid dosage forms: injektion preparations, eye drops, nose drops, sprays, tablets, capsules, sachets, others
- Capacities: >180 million liquid units/a, 1 billion tablets/a, 50 million capsules/a and 10 million sachets/a
(PN 1605)
Optimization of an aseptic production for semi-solid and liquid dosage forms for the Wirtschaftsgenossenschaft deutscher Tierärzte, 2012, Germany
- Analysis of existing production proce-dures + bottle-necks, hygiene concept, building equipment, room design
- Conceptual design for short-/ long-term optimization tasks + strategies
- Design/evaluation of optimized pro-duction procedures + investments for the implementation of new products
- Liquid and semi-solid penicillins and non-penicillins
- Capacities: approx. 2700 t animal raw material/a up to 62 million units/a
(PN 1574)
Construction of a new pharmaceutical OSD production facility, 2012, Russia
- Conceptual design with options for extension including process design and dimensioning, layout, cGMP concept, HVAC, peripherals like laboratory, laundry, administration, cost estimation
- New building for production, storage and administration
- Solid dosage forms (OSD) with capacities of 200 million tablets/year, 20 million capsules/year and 40 million ampoules/year
(PN 1527)
Construction of a new pharmaceutical production facility for OOO Feron, 2012, Russia
- GMP review
- New building: approx. 1700 m² production, approx. 1200 m² storage, approx. 800 m² laboratory
- Semi-solid dosage forms: APIs and ointments, gels and suppositories
- Capacities: 10 million packages of suppositories, 3 million packages of ointments + gels
(PN 1503)
Construction of a new pharmaceutical production facility for SOLOPHARM, 2012, Russia
- Concept including comparison of alternative variants of different filling technologies. Basic and detail engineering for the technological process with media supply
- New building: 15,500 m³ effective area
- Blow-Fill-Seal (BFS)
- Infusion Solutions (LVP) with a capacity of 30 million PP-bottles/year
(PN 1550)
Enlargement of a pharmaceutical production facility for solid dosage forms, 2012, Czech Republic
- Conceptual design and basic engineering for production rooms with main equipment e.g. granulation with vertical product flow, tableting/compaction with gravimetric feeding
- Enlargement of the existing production building: 3 production levels, about 20.000 m2
- Solid dosage forms with highly Active pharmaceutical ingredient
- Output increase of 8 billion tablets/year, 50 % with API
(PN 1497)
Construction of a new production facility for solid dosage forms for R-Pharm, 2012, Russia
- Equipping the new production with a granulation line for total containment: adaptation of URS and detailed design of the customer, specification, delivery, installation and commissioning of the complete granulation line
- Solid dosage forms (OSD): tablets, capsules with capacities of 116 kg/batch
(PN 1551)
Design upgrade to OEL level 5 of an existing solids production, 2011, Finland
- GMP concept focused on:
– clean room zones
– material flow
– personnel flow
– pressure zones
– description of HVAC modification
– cost estimation for later realization - Solid oral dosage forms (OSD): bulk material and API
(PN 1535)
Construction of a new production facility for Neon OOO, 2011, Russia
- Conceptual and Basic design: development of site master plan including options for further extension, general design, building concept, layout, authority engineering
- New building complex for production, laboratory, warehouse, administration, media
- Solid oral dosage forms (OSD) with a capacity of 760 million tablets/a and 240 million capsules/a
(PN 1534)
Displacement and modernization of a production facility for OOO Samson-Med, 2011, Russia
- Conceptual design of the production areas according to GMP and of the entire building complex
- New building complex for production, laboratory, warehouse, administration, media
- Medical preparations from animal organs, liquid sterile and non-sterile dosage forms, solid dosage forms
- Capacities:
approx. 2,700 t animal raw materials
62 million units liquids/year
40 million tablets/year
25 million capsules/year
100 million sachets/year
(PN 1528)
Construction of a new production facility for Karaganda Pharmaceutical Complex, 2011, Kazakhstan
- Conceptual design and basic engineering (technological project), equipment specifications, GMP-review
- New building; 1,800 m2 effective area
- Solid dosage forms (OSD) with capacities of 75 million tablets/year and 25 million capsules/year
(PN 1350)
Construction of a new pharmaceutical production facility for OOO PIK-Pharma, 2011, Russia
- Conceptual design of the new production complex including options for extension: technological solutions and all engineering systems, architectural design of production buildings, requirements for constructional design
- New building complex for production, laboratory, warehouse, administration
- Solid and liquid dosage forms
- Capacities: 160 million tablets + capsules/a, 6 million sachets/a and 1.8 million vials solution+ syrup/a
(PN 1485)
Modification of an existing pharmaceutical production facility for Apogepha Arzneimittel, 2010, Germany
- MP-review and capacity analysis with the main focus on: cleanroom zone concept of production area, material flow, personnel flow, pressure zone concept, media supply, calculation of qualification effort
- Solid dosage forms (OSD)
(PN 1220)
New facility for the production of human blood plasma derivates for ROSPLASMA, 2010, Russia
- Turnkey project for th new production facility and set-up a network of modular plasma source establishments
- Blood plasma fractionation of 600,000 l/year to
– Albumin in 50 ml, 250 ml bottles with a capacity of 1,600,000 bottles/year
– IgG Immunglobulin in 50, 100, 200 ml bottles with a capacity of 440,000 bottles/year
– Factor VIII in 20 ml bottles with a capacity of 134,000 bottles/year
– Factor IX in 20 ml bottles with a capacity of 94,000 bottles/year
(PN 1451)
New production facility for pharmaceuticals and medical devices for Medchimprom, 2009, Russia
- Conceptual design: process design and dimensioning, layout, cGMP concept, HVAC, peripherals (like laboratory, laundry, administration), cost estimation
- New buildings for production, storage and administration
- Multiple dosage forms: aerosols, ampoules, tablets, fizzy tablets and medical devices (single use syringes)
- Capacities: 2 million aerosol units/year; 60, 100, 112, 120 and 200 dosages per unit
(PN 1449)
Construction of a new pharmaceutical production facility for Novartis Pharma AG, 2009, Russia
- Conceptual design of entire compact building complex including options for extension: layout, master plan, URS preparation, time schedule, cost estimation, site inspections, review report on costs for infrastructure and evaluation of landscape protection
- Building: complex for production, laboratory, warehouse, administration, media
- Solid dosage forms with capacities of 0,5 billion/a bulk production and 1 billion/a packaging
(PN 1367)
Construction of a new production facility for contract manufacturing of pharmaceutical and food ingredients, IPC Process Center, Germany, 2009
- Turnkey engineering: complete design, delivery and implementation
- New building
- GMP-Granules and Pellets: various granules and pellets for pharmaceutical, food/ingredients, e.g. enzymes and flavors
- Capacities: 100 – 1.000 kg/h, depending on product
- Technology: continuous spray-granulation, agglomerating and drying by Glatt fluid bed and spouted bed technology, ProCell 250 with GF 250 process insert
(PN 1412)
Extension of a containment contract manu-facturing + new warehouse for Glatt GmbH, Germany, 2009
- Turnkey project for the new warehouse with qualification (RA,IQ,OQ) and conceptual design for the technology center with implementation into the existing production incl. layout, master plan, framework time scheduling, cost estimation, compliance to safety requirements for containment production
- New GMP conform storage facility + extension of technology center, 5.500 m2
- Solid Dosage Forms (OSD): contract manufacturing of tablets and capsules with storage of raw material and final products
(PN 1417)
Extension of a production facility for B.Braun Melsungen, Germany, 2008
- Conceptual design study for site expansion: layout design, cGMP-concept, improvement of technology and process sequences, specification of area and equipment requirements, cost estimation
- New production building and storage re-organization
- Single used medical devices: bloodline (dialysis tubes), WDS (wound drainage systems), IV sets, Pro-set, Standard-Plus
(PN 1220)
Set-up a network of modular plasma source establishments for ROSPLASMA, 2008, Russia
- Turnkey project: supervision of preparation of strip foundation on-site, modules design and construction, shipping of completely self- supporting pre-installed room modules, set-up, assembly and installation on site training of station personnel and commissioning
- Set-up of 13 GMP EU-conform container modules with functional and production area each
- Plasma Pheresis with a capacity per station of 8,000 l up to 12,000 l blood plasma/a (1 shift à 10 h, 5-7 donation beds)
(PN 1277)
Construction of a new production facility for contract manufacturing of pharmaceutical and food ingredients, IPC Process Center, 2007, Germany
- Turnkey project = product trials, feasibility study, process development, complete engineering including building, project management, delivery, construction site and assembly supervision, installation, commissioning/start-up, operator training, qualification/validation
- Batch agglomeration, drying, coating, and pelletizing in a Glatt fluid bed granulator type GPCG 300
- GMP-Granules and Pellets: various granules and pellets for pharmaceutical, food/ingredients (e.g. enzymes and flavors)
(PN 1365)
Construction of a new pharmaceutical production facility for AB Pharm, 2007, Kazakhstan
- Concept and basic engineering of the technological solution and all technically engineered systems
- New buildings for production, warehouse, media, administration
- Standard infusion solutions in PE-bottles having a volume of 500 ml and 250 ml
- 30 million units/year by two bottling lines: 3,500 bottles/hour (1 line) and 7,000 bottles/hour (2 lines)
(PN 1285)
Establishment of new production capacities for NPK Pharmasoft OOO, 2007, Kazakhstan
- Conceptual design + basic engineering: structuring and optimization of technology and process sequences, specification of area and equipment requirements, cost estimation, cGMP-concept, layout design
- Reconstruction of an existing building complex and extension to 4 levels
- Solid and liquid dosage forms
- Capacities: 65 million injection solution (vials)/a, 200 million tablets/a and 200 million capsules/a
(PN 1212)
Changeover from batch to FDA approved continuous production for an API of a x-ray contrast agent, GE Healthcare, Norway, 2007
- Process development, process engineering, design, delivery, implementation of a continuous fluid bed spray granulator; qualification (DQ, IQ, OQ), validation support, re-design of liquid transfer system, working at site during running production
- Continuous spray granulation and drying in a Glatt fluid bed granulator type GFG 350 with a capacity of 270 kg/h
- Production area at 3 levels with 120 m2 each, very constricted room situation
- API of a X-Ray contrast agent: Iodixanol powder granulated from aqueous suspension
(PN 1233)
Reconstruction of a production facility for solid dosage forms for Boehringer Ingelheim Pharma, 2007, Germany
- Feasibility study for process technology: layout design, GMP concept, integration of new and existing equipment, specification of media requirements, time scheduling and cost estimation
- Delivery and commissioning of Glatt pellet coaters and peripheral process equipment
- Reconstruction of an existing chemical production building
- Solid dosage forms (OSD): coated pellets, each charge à 600 kg
(PN 1139)
Construction of a new production facility for Gilead Sciences (Altana Pharma), 2006, Ireland
- Conceptual, basic and detail design for process technology:
– modular room design for weighing, fluid bed technology, blending, tableting and film coating
– dynamic process simulation - Qualification: preparation of URS, DQ, risk analysis, IQ/OQ templates
- New production building
- Solid dosage forms (OSD) with a capacity of 4,000 million tablets/year
(PN 1205)
Installation of new pharmaceutical production facility for Pharmsynthez OAO (SPb), 2005, Russia
- Feasibility study for the installation of new pharmaceutical production facility in an existing building shell and/or on a green field beside the existing API production: verification of the assignment, determination of technical and economic parameters of the business plan, designing a layout
- Solid (OSD) and liquid dosage forms: tablets, capsules, syringes with a capacity of 15 million units/year
(PN 1124)
Construction of a new pharmaceutical production facility for Galenika a.d., 2005, Serbia
- Extended preliminary design according to GMP & FDA-standard:
– process, building service and architecture
– implementation of existing and new equipment – also Glatt equipment for weighing and dispensing, blending, granulation, coating - Reconstruction of an existing building
- Solid dosage forms (OSD): 70 different tablet products and 10 different capsule products
- Capacity: 1,800 million units/year
(PN 1023
Construction of a new production facility for Gematek OOO, 2005, Russia
- Turnkey project: complete design and realization and commissioning
- Blow-Fill-Seal (BFS) technology
- Reconstruction of a production hall carcass, interior finishes (floor, wall, ceiling)
- Infusion solutions (LVP): infusions in PE-bottles of 100 ml, 250 ml and 500 ml
- Capacity: 2,400 bottles/hour up to 16 million bottles per year
(PN 1158)
Construction of a new launch site facility in an existing building for Boehringer Ingelheim Pharma, 2004, Germany
- Process engineering:
– technical project management for engineering of process technology and building services
– basic design with layout for develop-ment, safety and GMP concept
– detail design
– preparation of tendering documents
– supervision of installation
– integration of coaters from Glatt and other supplier - Solid dosage forms(OSD)
(PN 1153)
Renovation and GMP-upgrading of a solid drugs production facility for Farmak OAO, 2004, Ukraine
- Feasibility study and conceptual design according to EU-GMP and FDA: structuring and optimization of the production program, process flow, useable technologies, equipment requirements, space requirements, layout design, GMP concept, cost estimation
- Reconstruction of an existing building
- Delivery of process equipment
- Solid dosage forms (OSD) with a capacity of 500 million units (tablets)/year and 120 million units (capsules)/year
(PN 1006)
Construction of a new pharmaceutical production facility for Big Pharma, 2004, Israel
- Conceptual and preliminary design for the entire process technology and logistics from goods receiving, storage and warehousing, dispensing, granulation, pelletizing, tabletting, coating, capsule filling, packaging and shipping including process simulation and hygienic concept
- Integration of Glatt technologies for weighing, fluid bed technology, blending, handling, container washing
- Solid dosage forms (OSD): tablets and capsules with a capacity of 8,000 million units/year
(PN 0808)
Construction of a new milk and dairy line for GP VVO Selkhospromexport, 2002, Russia
- Turnkey project: basic and detailed engineering, delivery, assembly, installation and commissioning of entire equipment, staff qualifying/training, process control
- Reconstruction of an existing building
– technological equipment 1,800 m²
– 4 laboratories 120 m²
– utilities supply 200 m² - Delivery of process equipment
- Liquid and pasty baby & child food, yogurts and fruit juices with a capacity of up to 30,000 l unpasteurized milk, 2 shifts
(PN 0834)
Construction of a new production facility for the contract manufacturing of pharmaceutical, food and feed ingredients, IPC Process Center, Germany, 2002
- Batch wet granulation, spray agglomeration, drying and coating, Glatt high shear mixer and fluid bed granulators and coater GPCG 300 with 46″-Wurster, GMP design
- Scope of our services and supply: turnkey project = product trials, feasibility study, process development, complete engineering including building, project management, delivery, construction site and assembly supervision, installation, commissioning/start-up, operator training
(PN 0877 + 0903)
Extension of an existing pharmaceutical production facility, 2001, Germany
- Conception and design for the production areas for bulk production, bottling and packaging, including ethanol storage and connection to the existing stock (2000)
- Detailed design for selected main production equipment and the plant for the production and distribution of purified water
- Detailed HVAC design and room book for the production areas
- New building as extension on existing buildings
- Liquid and semi-solid dosage forms wit capacities of approx. 480 t/a ointments and approx. 290 t/a non-sterile liquids
(PN 0293)
Construction of a new clean room laboratory for the Friedrich-Schiller-University Jena, 1999, Germany
- Complete engineering and implementation of a pharmaceutical clean room laboratory including water treatment:
– Feasibility study and conceptual design
– Basic and Detailed engineering
– Process technology
– Delivery and installation of equipment
– Start-up (clean room, floor, HVAC, piping, ELT, integration of existing lab units) - Clean room classes: 100 / 10,000 / 100,000 including changing rooms
(PN 0021)
Construction of a new production facility for Biomed, 1998, Ukraine
- Turnkey project: complete design, engineering, delivery, construction and commissioning
- BCG-vaccines
- Licensor: Behring Werke AG, Marburg, Germany
(PN 0012)
Construction of a new pharmaceutical production facility for PrJSC «INDAR», 1997, Ukraine
- Turnkey project: complete design and realization and commissioning
- Reconstruction of an existent building, interior finishes (floor, wall, ceiling)
- Pure insulin preparations (SVP): insulin solutions and suspensions in 10 ml vials (SVP) with a capacity of 6,000 vials/hour up to 12 million vials per year
- Licensor: Hoechst AG, Frankfurt, Germany
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