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CONTRACT MANUFACTURINGALANNO PLANT
Buildingyourprojects
Summary
1. The foundations: the soundness of a leading company in the industry
2. Building the project via the provision of services, one step after another
3. The project develops, our support is on-going
4. The project takes shape and materializes
5. The project gets approval: regulatory affairs support
6. The project takes form: diversity of pharmaceutical forms
7. The project comes alive: the Alanno manufacturing plant
Alfa Wassermann is a pharmaceutical company which presents itself as an ideal partner in Contract Manufacturing, supplying a complete integrated service in pharmaceutical outsourcing activities. High quality standards and reliability characterize the Third party manufacturing which includes nearly all pharmaceutical forms. Quality is guaranteed by specific know how acquired over more than 60 years, by the strength of the company values (innovation, perfection, diversity and focus on results) and from using innovative technologies. All of this is achieved in a high-tech pharmaceutical plant which has recently been enlarged and improved.
The foundations
The soundness of a leading company in the industry
1
The Alfa Wassermann Contract Manufacturing Division is organized to provide its Customers all support services for the development, manufacturing and quality control of their products. It has a dedicated structure which starts with formulation development and ends with production of batches for sale in the market, covering almost all pharmaceutical forms.
Analysis and formulation development:• Optimizationofmanufacturingprocessesandofpharmaceuticalformulation• Scaleup• Manufacturingoftechnicalbatches• Pilotbatches• Validationofmanufacturingprocesses
Building the project via the provision of servicesOne step after another
2
Thanks to the experience and support of a laboratory furnished with the very best equipment, the Analytical Development Unit is able to develop and validate analytical methods, carry out stability studies testing and offer constant and efficient support during the formulation development stages to guarantee product reliability and safety.
Analytical services and methods development:• Chemicalandbiologicalmethodsdevelopment,transferandvalidation• Forceddegradationstudies• ICHstabilitystudies
The project develops
Support is on-going
3
The manufacturing stage of batches for clinical trials includes nearly all pharmaceutical forms.
Batch preparation:• Manufacturingandpackagingofbatchesforclinicaltrial• Managementofrandomizationlists• Releaseofbatchesforclinicaltrial
The project takes shapeand materializes
4
Thanks to the excellent technical-legislative knowledge of industry regulations, Alfa Wassermann is able to guarantee highly professional regulatory services. Alfa Wassermann keeps pace with the continuous national and international technical-regulatory updates to ensure marketing authorizations for the products are obtained.
Regulatory activities:• PreparationofCTDvariations• Preparationofregistrationdossiersfornewsubmission
The project gets approval Regulatory affairs support
5
6There are specialized, dedicated departments for every type of formulation which guarantee maximum versatility and manufacturing efficiency. All this is supported by a quality system which guarantees product reliability in every step of the process until the final release is issued for the destination countries. Pharmaceutical forms:• Oralsolids(granules,tablets,film-coatedtablets,hardgelatincapsules)• Liquidinjectables(terminallysterilizedliquidampoulesandvials,aseptically processed liquid ampoules and vials, pre-filled syringes)• Lyophilizedproducts(lyophilizedampoules,lyophilizedvials)• Asepticallyprocessednasalsprays• Oralliquids(drops,extemporaneousdrops,syrups,extemporaneoussyrups)• Semi-solidsandnon-sterileliquids(creams,gels,ointments,emulsions, mouthwashes)
The project takes form
Diversity of pharmaceutical forms
7
The manufacturing plant devoted to Contract Manufacturing is located in the industrial area in Alanno,approximately25KmfromPescara(Abruzzoregion,Italy).Theplantcovers an area of 100,000 m2 and it is divided into 11 departments housed in 7 buildings. The area has been designed to rationalize space, streamlining work flows to maximize efficiency.
Atotalof35millionpiecesayeararemanufacturedandpackagedattheplantformajorItalian and international pharmaceutical companies.
The project comes alive
The Alanno manufacturing plan
Focus on
Lyophilized products
Liquid injectables
Semisolids and non-sterile liquids
Oral solids
Scientific and development services
Lyophilized products
The lyophilization area, with a total freeze-drying surface of 91 m2 equipped with two freeze-dryers for large batches, and two freeze-dryers for small and medium-sized batches, is located in the cutting-edge sterile department covering a total surface of 2,000 m2. The equipment is fed by high-tech, very efficient and extremely reliable filling lines. The know-how acquired over many decades of operating in the lyophilization sector of pharmaceutical products covering many molecules, including hormones and long-chain peptides, ensures our customers receive a guaranteed result and ensures technology transfer processes are efficient.
Pharmaceutical Form
• Lyophilizedampoules• Lyophilizedvials
Packaging
•Ampoules - diameter 10.75 to 17.75• Lyophilizedvialscapacityupto100ml
Active Ingredients (most frequently manufactured)
• Indomethacin•Acetylcholine•Aceclidine• Pirenoxinesodium•Cyanocobalamin• CalciumFolinate• Somatostatin•Collistimethate sodium• Omeprazole• Pantoprazole•Glutathione sodium•Ketoprofen•Dihydralazine mesylate ...and many others
Pharmaceutical Form
• Lyophilizedampoules• Lyophilizedvials•Ampoule packaging• Vialpackaging
Annual Production Capacity
72,000,000 pcs21,375,000 pcs13,200,000 boxes6,300,000 boxes
Liquid injectables
Oursteriledepartments,coveringadedicatedareaofover2,000m2, process pre-filled syringes, ampoules and vials using both aseptic processing and terminal sterilization. In a space near to the sterile departments, there are areas dedicated to quality control of the ampoules and both automatic and manual packaging.
Pharmaceutical Form
• Pre-filledsyringes• Terminally sterilized ampoules•Aseptically processed ampoules• Terminally sterilized vials•Aseptically processed vials• Vialsfilledwithsterilepowder
Packaging
•Glass ampoules - diameter 10,75 to 17,75• Vials-capacityupto100ml• Pre-filledsyringes
Active Ingredients (most frequently manufactured)
•Diclofenac• Lowmolecularweight heparins• Ranitidine•Nizatidine• Lidocaine•Ketoprofen•Apomorphine•Caffeine•Ambroxol• Sulodexide• Tobramycin•Calcitonin• CalciumFolinate ...and many others
Pharmaceutical Form
• Pre-filledsyringes• Terminally sterilized ampoules•Aseptically processed ampoules• Liquidinjectablevials•Ampoule packaging• Vialpackaging
Annual Production Capacity
14,000,000 pcs60,000,000 ampoules60,000,000 ampoules 72,000,000 vials13,200,000 packages6,300,000 packages
Semisolids and non-sterile liquids
In line with our policy to diversify our offer, a wide range of liquids and semi-solid products ismanufactured:suspensions,drops,creams,gels,naillacquers,single-dosePETbottlesand vaginal douches available in different types of packaging for the various formats.The preparation departments are equipped with machinery that can process different batch sizes and the division and packaging lines can process the many different pharmaceutical forms including the following: aluminium tubes (small and medium volumes),glassbottlesforsyrups,drops,PVCbottles,naillacquerbottles,nonstandard-sizePVCbottles.
Pharmaceutical Form
•Creams•Gels•Non-sterile solutions for topical use• Ointments• Emulsions•Mouthwash• Vaginaldouches
Packaging
•Aluminium and plastic tubes• PETbottles•Glass bottles•Nail lacquer bottles• Spraydispensers•Bottles with dropper• Single-dosePETbottles
Pharmaceutical Form
•Creams•Gels•Non-sterile solutions
Annual Production Capacity
4,500,000 pcs4,500,000 pcs9,000,000 pcs
Oral solids
Onepavilionoftheplantiscompletelydedicatedtothemanufacturingoforalsolids.The area is divided in 4 departments that work indipendently in order to guarantee maximumversatilityandmanufacturingefficiency.Smallandlargevolumescanbeprocessed making it possible to carry out industrial scale up operations and support activities such as formulation development. Numerous types of packaging formats makethedepartmentsveryflexibleandmeantheyareabletoadjusttopackagingrequirements.
Pharmaceutical Form
•Granules•Hard-gelatin capsules• Tablets: simple - film-coated modified release - multilayer Hard gelatin capsules
Packaging
• GlassandPETbottles• BlistersmadeofALU/PVCandALU/PVDC
Active Ingredients (most frequently manufactured)
•Diclofenac •Rifaximin• Verapamil•Clarithromycin•Hydroxychloroquine sulfate• Eperisone•Metronidazole•Ketoprofen •Nicergoline•Chromocarb •Penicillamine
Department 1
Wet granulation - Dry granulation - Capsule filling - Compressing - Tablet coating
Department 2
Wet granulation - Dry granulation - Compressing
Department 3
Dry compacting - Compressing
Department 4
Dry granulation - Compressing - Tablet coating - Tablet stamping
Pharmaceutical Form
• Tablets/Capsules• Packs(20tablets)
Annual Production Capacity
2,200,000,000 pcs70,000,000 pcs
Scientific and development services
The Contract Manufacturing Division of Alfa Wassermann is organized to provide its customers with all manufacturing support services. It has a dedicated structure which, thanks to over 60 years’ experience in the pharmaceutical sector, can meet customer requirements, providing assistance and supporting production from formulation development to preparation of dossiers.The Analytical Development unit provides assistance in technology transfer procedures and is able to develop analytical methods.
• Formulationdevelopment
•Analytical services and method development
•Batches for clinical trials
• Regulatoryaffairs
• Optimizationofproductionprocessesandpharmaceuticalformulation• Scaleup• Validationofproductionprocesses
•Method development, transfer and validation•Degradation studies• ICH stability testing
•Manufacturing and packaging of batches for clinical trials
• PreparationofCTDvariations• Preparationofregistrationdossiers
Alfa Wassermann S.p.A.
Via Enrico Fermi 1 - 65020 Alanno (PE) - Italy
Tel. +39 085 8571226 - Fax +39 085 8543128
www.alfawassermannmanufacturing.it
