CASE HISTORIES

PRODUCT AND NEW TECHNOLOGY

International Pharmachim has a diffused international experience having obtained important and prestigious contracts in Libya, Lebanon, Russia, Indonesia, Korea, India and China

Our Team is our hidden strenght

GENERAL MANUFACTURING OF PHARMACEUTICALS AND MEDICAL SUPPLY COMPANY (Libya) 

Turn key plant, basic and detailed engineering for the revamping of the Bulk Plant for the production of Active Pharmaceutical Ingredients (API) in solid dosage form.

AL RABTA PHARMACEUTICAL (Libya)  

Turn key plant, basic and detailed engineering (civil, electrical and mechanical) of a new plant for the formulation in solid dosage forms, including validation complying with EU GMP and FDA standards.

TRIPOLI (Libya)

Study, implementation and support in the development and the presentation to the OPCW of the complete documentation for the riconversion of the chemical plant Pharma-150.

BIOSEARCH MANUFACTURING (Italy)

Turn key plant, basic and detailed engineering (civil, electrical and mechanical), cGMP and FDA validation, supply of the pharma walls and the HVAC system, for both fermentation plant and laboratory in Pisticci for the production of antibiotics bulk material.

NATIONAL PHARMACEUTICAL AND MEDICAL EQUIPMENT Co. (Libya)

Site Survey, basic engineering for the revamping of the existing Bulk Plant in Al Rabta and for the implementation of a new unit for the formulation in oral solid dosage form.

SANMENXIA TRANSPORTATION CENTER (Sanmenxia, Hunan – China)

Joint Venture and Turn-key fermentation plant supply for the production of pharmaceutical bulks. (Under implementation)

SETEX FARM LTD COMPANY (Maikop, Adighey – Russia)

Joint venture undertake of a stock-house for import and distribution of medical specialties in collaboration with the Ministry of Health of Russia. (Still operational)

MAIKOP SCIENTIFIC PRODUCTIONS AMALGAMATION OF THE CENTRE OF NEW MEDICAL AND SPECIAL TECHNOLOGIES (Maikop, Adighey – Russia)

Supply of medical technologies for production of advanced pharmaceutical specialties. (Still operational)

SANMENXIA TRANSPORTATION CENTER (Sanmenxia, Hunan – China)

Turn-key fermentation plant supply for production of food additives. (Under implementation)

SOC. THERAMED (Tunis – Tunisia)

Turn-key supply of plant for medical specialties production, technical assistance and training.

HARBIN PHARMACEUTICAL FACTORY (Harbin – China)

Production of Antibiotics: supply of strain, production know-how, basic engineering and technical assistance.

WUXI FORTUNE PHARMACEUTICAL COMPANY JOINT VENTURE UNDERTAKING IN WUXI – CHINA FOR PRODUCTION OF HUMAN AND VETERINARY ANTIBIOTIC

Supply of strain, productive know-how, basic engineering, technical assistance and training. (Still operational)

POLFA TARCHOMINSKIE (Warsaw – Poland)

Production of Antibiotics: supply of strain, process know-how and technical assistance.

WUXI No. 1 PHARMACEUTICAL FACTORY (Wuxi – China)

Plant producing Antibiotics: supply of strain, process know-how, technical assistance and staff training in foreign plants utilising Pharmachim Engineering technology. (Still operational).

CHINA NATIONAL CONSTRUCTION COMPANY (Beijing – China)

Urea plant : automatic raw material feeding equipments for Xuanhua Chemical Fertilizer Company.

CHINA NATIONAL CONSTRUCTION COMPANY (Beijing – China)

Urea plant: automatic raw material feeding equipments for Beijing Chemical Experimental Company.

CHINA NATIONAL CONSTRUCTION COMPANY (Beijing – China)

Urea plant: automatic raw material feeding equipments for Yuanping Chemical Fertilizer Company.

T.I.S. (Rovereto – Italy)

Project for plant producing 170 millions of disposable syringes : supply of know-how, equipments and technical assistance.

BIOMEDICAL DIAGNOSTIC KITS CREATION OF JOINT VENTURE COMPANY (Sardinia– Italy)

Turn-key supply of laboratory with the know-how, technical assistance and staff training for enzymatic and blood diagnostic kits.

UB GROUP PHARMACEUTICAL DIVISION (Bangalore – India)

Project for plant producing veterinary antibiotic : supply of know-how, equipments and technical assistance.

CEFOSINT A.G. (Rovereto – Italy)

Project for production plant for generic antibiotics:
– Beta-Lactamics (sterile vials, capsules and sirops)
– Non Beta-Lactamics (sterile ampules, lyophilized vials and micro vials, powed vials)

MAHIDOL UNIVERSITY (Bangkok – Thailand)

Supply of complete vaccine production plant (Dengue fever and Hepatitis B)

PHERPHARMA INC. CREATION OF JOINT VENTURE IN MANILA – PHILIPPINES FOR PRODUCTION OF DISPOSABLE PHARMACEUTICALS PRODUCTS

Supply of management, know-how, equipments and technical assistance.

PHARMACHIM DEL PACIFICO CREATION OF JOINT VENTURE COMPANY IN SAN JOSE’ DE COSTARICA FOR PRODUCTION PLANT OF DISPOSABLE PRODUCTS

Supply of know-how, equipments, technical assistance and staff training.

DUPHARM (Dubai – U.A.E)

Plant for manufacturing of disposable syringes, annual capacity 60,000,000 units: supply of know-how, equipments, technical assistance and staff training.

P.T. RIKA FARI PUTERA (Jakarta – Indonesia)

Universal fermentation pilot plant for antibiotic research and development : supply of know-how, equipment, technical assistance and staff training.

P.T. AVINDO PRIMA (Jakarta – Indonesia)

Plant for production of 180,000,000 units per year of glass ampules and vials : supply of know-how equipments, technical assistance and staff training.

POLFA (Warsaw – Poland)

Production of Antibiotics : supply of six fermentors of 63 cu.m. each.

New HPAPI Plant

Client: Aspen
Location: Cape Town
Project description: New HPAPI Plant
Plant Description: Two new Buildings, divided in 4 suites each with Bulk Solvents Park and Utilities.
Services: Conceptual Design, Process Design, Automation Design, Construction Supervision, Computer System Validation

Complete Refurbishment of and existing Production Site

Client: Polpharma
Location: Algeria
Project description: Complete Refurbishment of and existing Production Site
Plant Description: Site Master Plan for the refurbishment of an existing plant, including capacity study, Lay-outs, utilities evaluation, estimate and construction schedule
Services: Site Master Plan

New production site for LVP and SVP Product

Client: REPUBLIQUE DU CHAD
Location: TCHAD
Project description: New production site for LVP and SVP Product
Plant Description: New site for the production of Oral Solid, Antiobiotics, Infusion Bags, including production, utilities building, QA and QC buildings, Canteen, offices, parking road, etc.,..
Services: Feasibility and conceptual design

High Active and conventional OSD and injectable plant

Client: ADCAN PHARMA
Location: ABU DHABI (UAE)
Project description: High Active and conventional OSD and injectable plant
Plant Description: New facility dedicated to the production of the following products typology: Conventional OSD Forms, High Potent Sterile product, High Potent OSD Forms. The new site will include warehouse, technical and process utilities, etc.,.. The design includes design for all branches, excluding civil and structural
Services: Conceptual and Basic

API and OSD Plant for antiretroviral production

Client: LABAT
Location: JOHANNESBURG (South Africa)
Project description: API and OSD Plant for antiretroviral production
Plant Description: Revamping and extension of existing site, for 240 ton/year antiretroviral products for African market
Services: Conceptual Design

API Production Plant

Client: Promochimica
Location: Tunisia
Project description: API Production Plant
Plant description: Plant is multipurpose for the manufacture, via chemical synthesis of final API of 4 categories (Anaesthetics, Antidiabetics, Neurolectics, Antiviral). One final API will be in bulk liquid form, all other products will be solid, and Products will Suitable to be used in injectable preparations. Areas involved: Reactors, Purification, warehouse, utilities
Services: Conceptual, basic engineering and detailed engineering

Vaccine preparation by fermentation, formulation and filling (HiB, TT, HiV)

Client: The Biovac Institute
Location: Cape Town (South Africa)
Project description: Vaccine preparation by fermentation, formulation and filling (HiB, TT, HiV)
Plant description: New building with the following areas: fermentation area (20lt and 200lt fermenters), purification area (Chromatography skids, UF/DF skids, final filtration devices), formulation and filling areas for preparation of injectables vials.
Services: Basic, Detailed design, Validation activities

New Liquid Preparation Facility

Client: ADCOCK INGRAM
Location: Johannesburg (South Africa )
Project description: New Liquid Preparation Facility
Plant description: Revamping of Penicillin Crystal Department, in three subsequent phases, with an extension of area, and contemporarily solving GMP problems. The activities were relevant to HVAC, Electrical, Mechanical, Pharmaceutical Finishing, Civil and Structure
Services: Feasibility, Conceptual, Basic

Revamping of bulk plant for synthesis and isolation of API for generics for AIDS, Malaria, TBC.

Client: THE NATIONAL PHARMACEUTICALS & MEDICAL SUPPLIES
Location: Al Rabta (Libya)
Project description: Revamping of bulk plant for synthesis and isolation of API for generics for AIDS, Malaria, TBC.
Plant description: Functional areas: synthesis, isolation/drying, utilities, warehouse. Main equipment: 5×3000 lt glass lined reaction units, 5×3000 lt inox reaction unit, 2 centrifugation unit diam. 1,2m, 4 tray dryers.
Services: Detailed design for revamping of existing synthesis, isolation and utilities area.

LVP new production site

Client: S-PHAR
Location: KSA
Project description: LVP new production site
Plant description: New site for the production of LVP, BFS bottle and PE bags.
Services: Feasibility, Basic Design, Detailed Design, Procurement, Construction Supervision, Commissioning and Validation

LVP new production site

Client: RENOVATIA
Location: KAZAKHSTAN
Project description: LVP new production site
Plant description: New site for the production of LVP, BFS bottle and PE bags. The study included production, warehouse, offices, QA and QC labs, utilities pre-sizing and HVAC and mechanical pre-definition, as well as static capacity study, to obtain an ±25% accuracy estimate
Services: Feasibility and Basic Design

Sterile Preparation and Filling Facility

Client: SALF
Location: Cenate – BG (Italy)
Project description: Sterile Preparation and Filling Facility
Plant description: Revamping of sterile department for large parenteral volume preparation and filling, including HVAC, electrical, finishing, mechanical engineering and installation
Services: Conceptual, Basic Detailed and LSTK

New Production Site

Client: UNI-PHARMA
Location: Greece
Project description: New Production Site
Plant description: SVP and LVP Production plant
Services: Conceptual design, Basic Design, Commissioning & Validation

Complete Refurbishment of and existing Production Site

Client: Polpharma
Location: Algeria
Project description: Complete Refurbishment of and existing Production Site
Plant description: Site Master Plan for the refurbishment of an existing LVP and OSD plant, including capacity study, Lay-outs, utilities evaluation, estimate and construction schedule
Services: Site Master Plan

High Active and conventional OSD and injectable plant

Client: ADCAN PHARMA
Location: ABU DHABI (UAE)
Project description: High Active and conventional OSD and injectable plant
Plant description: New facility dedicated to the production of the following products typology: Conventional OSD Forms, High Potent Sterile product, High Potent OSD Forms. The new site will include warehouse, technical and process utilities, etc.,.. The design includes design for all branches, excluding civil and structural
Services: Conceptual and EPC

Vaccine preparation by fermentation, formulation and filling (HiB, TT, HiV) BSL3, Cytotoxic

Client: The Biovac Institute
Location: Cape Town (South Africa)
Project description: Vaccine preparation by fermentation, formulation and filling (HiB, TT, HiV) BSL3, Cytotoxic
Plant description: New building with the following areas: fermentation area (20lt and 200lt fermenters), purification area (Chromatography skids, UF/DF skids, final filtration devices), formulation and filling areas for preparation of injectables vials.
Services: Basic, Detailed design, Validation activities

Biotechnology production plant

Client: BEIJING FOUR-RING BIO PHARMACEUTICAL CO., LTD.
Location: Beijing (China)
Project description: Biotechnology production plant.
Plant description: Plant area 16500 sqm, 4 buildings: offices and laboratories building, production building – bulk biotechnology area (1st floor) – Sterile secondary area with packaging lines for vials and syringes (ground floor) – Dormitory and canteen building, utilities production building.
Services: Conceptual design.

POLPHARMA (Poland)

GMP upgrading project of R&D laboratories (about 1500 sqm area). Basic and detailed Engineering.

RANGS PHARMACEUTICALS (Bangladesh)

Realization of a new grass root facility, including small and large Volume Parenterals, Quality Control and R&D Facility, Utilities, Offices, Cephalosporin Capsule and Cephalosporin Sterile Vials departments. Conceptual Study/Facility Planning, Detailed Engineering

SANOFI AVENTIS (Italy)

Detailed Engineering and Construction Supervision of the new Oral Solid Department.

MENARINI PHARMACEUTICAL (Italy)

Basic Engineering, Detailed Engineering, Procurement Support, Construction Supervision of a new Biotech Plant.

CHIESI FARMACEUTICI (Italy)

Upgrading of the Oral Solid Department. Functional areas involved are: Production, Primary and Secondary packaging, Washing area, Changing rooms. Basic Engineering, Detailed Engineering, Procurement and Construction Supervision.

DOPPEL FARMACEUTICI (Italy)

Conceptual Study/Facility planning of the Effervescent Production Department.

DOPPEL FARMACEUTICI (Italy)

Detailed Engineering and construction supervision of the Sachets Packaging line (primary and secondary)and technical area (HVAC) based on 250 sqm area.

BIOSEARCH MANUFACTURING (Italy)

Engineering, Procurement Assistance and Follow-up, Commissioning and Validation of the fermentation plant in Pisticci Italy for the production of antibiotics bulk material.

BIOSEARCH MANUFACTURING (Italy)

Engineering, Procurement Assistance and Follow-up, Commissioning and Validation of the fermentation plant in Pisticci Italy for the production of antibiotics bulk material.

SIRTON PHARMACEUTICAL (Italy)

Support activities for instrument calibration management. Equipments & Plant Validation.

RBM – SERONO (Italy)

Instrument Calibration af the all Site. Equipments & Plant Validation

SANOFY AVENTIS (Italy)

Engineering Documentation Review, FAT,SAT, Commissioning, System Impact Assessment, Component Impact Assessment IQ/OQ/PQ writing and execution of the new Enterogermina Plant.

SCHERING PLOUGH (Italy)

IQ/OQ Protocol writing and execution of a new Tumbler. Equipments & Plant Validation.

CHIESI FARMACEUTICI (Italy)

Validation of a department dedicated to a sterile suspension bulk production. Services include User Requirements Specifications, Risk Analysis, Design Qualification, Calibration Plan, FAT and SAT support, IQ and OQ writing and execution.

PFIZER PHARMACEUTICAL (Italy)

Sugen project commissioning and qualification services. Equipments & Plant Validation.

ROCHE (Italy)

IQ/OQ/PQ qualification activities for some equipment (hoods, sterilizing ovens, incubators) located in the Microbiologic Laboratory. Equipments & Plant Validation

ACRAF ANGELINI (Italy)

Mono-dosage and Pluri-dosage Eye-drops areas: HVAC system balancing re-check and requalification activities execution. Equipments & Plant Validation.