Welcome
ABOUT HAMELN PHARMA About us With over 60 years of experience hameln pharma is the specialist for contract manufacturing of sterile solutions and suspensions filled in ampoules and vials. 2
ABOUT HAMELN PHARMA History 2005 Corporate Reorganisation Division into three companies to better focus on the activities of development manufacturing and own label sales 1995 Begin of Generic Development Activities Start to develop range of injectabel controlled drugs 1980 Concentration of Parenteral products Concentration on contract manufacturing, discontinuation of tableting activities, 1970 New Start on a then Greenfield Site From cramped inner city location to purpose build facility 1950 From pharmacy to factory Inner City Begin to produce pharmaceutical products on industrial scale, foundation of the Pharmazeutische Fabrik Hameln 3
ABOUT HAMELN PHARMA Recent Site History 2012 New packaging plant Reconstruction of the former sterile production plant to introduce a modern plant for visual inspection and to enhance packaging capacities. 2008 New sterile production plant Investing in new sterile facility in Hameln to keep up with state of the art manufacturing technologies for long term. 2001 New Warehouse Introduction of a new fully automated warehouse with a maximum of storage places in a limited space and exceptionally large capacities for controlled drugs. 4
MANUFACTURING PLANT Process Flow 6 5 1 2 4 3 1 Goods in 4 Optical inspection / packaging 2 Material transport 5 Storage 3 Compounding / Filling 6 Goods out 7
Process Flow 6 5 1 2 4 3 1 Goods in 4 Optical inspection / packaging 2 Material transport 5 Storage 3 Compounding / Filling 6 Goods out 8
Sterile Production Plant Received ISPE Facility of the Year Award 2009 in the category Operational Excellence 9
Our Services Ampoules and vials Compounding Visual inspection Packaging Filling Labelling Quality Control Special abilities Anaesthetics Suspensions Flammable liquids Cold chain products Oxygen sensitive products 10
Layout of Sterile Production Plant (4,000 m² clean room area) Controlled area (10%) Clean room class D (47%) Clean room class C (25%) Clean room class B (15%) Clean room class A (3%) Pressure differentials: D: + 15 Pa C: + 30 Pa B: + 45 Pa A: + 45 Pa/laminar flow 1 Storage of raw materials 2 Sampling 3 Dispensing 4 Compounding Temperature: Humidity: 5 Sterile filtration 6 Filling 7 Terminal sterilisation 8 Cleaning and sterilisation of mobile equipment 22±2 C 30-60 % rel. 11
A perfect Combination of Functionality and Aesthetics Transparency and day light in virtually all rooms due to glass walls 12
A perfect Combination of Functionality and Aesthetics Zone concept supported by colour concept 13
A perfect Combination of Functionality and Aesthetics Water system (WFI 2900 l/h; HPW 5900 l/h) 14
A perfect Combination of Functionality and Aesthetics HVAC system 15
A perfect Combination of Functionality and Aesthetics Glove box weighing cabinet 16
A perfect Combination of Functionality and Aesthetics Compounding in Reactors from 7 to 3,500 L 17
A perfect Combination of Functionality and Aesthetics Sterile filtration in mobile containers 18
A perfect Combination of Functionality and Aesthetics Setting up machines in U-form reduces personnel and clean room area required 19
A perfect Combination of Functionality and Aesthetics Fully automated capping Process in class A 20
Filling lines Vials (2 ml - 100 ml) Line 42440 Vials 6R-250H Line 42460 Vials 2R-50R Line 42450 Vials 2R-6R Line 42480 Vials 2R-30H Ampoules (1 ml - 30 ml) Line 41475 Ampoules 1-3 ml Line 41478 Ampoules 1-25 ml Line 41477 Ampoules 1-10 ml Line 41479 Ampoules 5-25 ml 21
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Technical details of the facility 132 Mio filled units in 2013 on 4.000 m 2 clean room space (maximum capacity ca. 160 Mio. units/a) Shift models: Filling: 15 shifts / 5 day Packaging: 5-15 shifts/ 5 days (maximal possible: 21 shifts /7 days) Personnel: Filling: 139 employees Packaging: 137 employees Engineering: 13 employees 23
Visual Inspection and Packaging Process (ca. 5,000 m²) New area design offers optimal support of the visual inspection and packaging process Optimized flow of materials and personnel Visual Inspection Crack Detection Labelling Blister Packing Blister Packing Clearly defined areas for each operation Washing Day light and transparency due to glass partitions Office area Controlled area Clean room packing (class D) 24
Potential for Extension Flexibility & Vision hameln pharma is able to manufacture the sterile facility according to internationally acknowledged standards and at highest quality. It satisfies the requirements of international pharmaceutical companies in the long run. With a view to future development the hameln pharma production building has been designed in such a way that it can be adapted flexibly to future demands and needs: Roof allows for further extension (eg. high containment products, freeze drying) Whole building can be extended to either side Plant layout allows for a fast and easy exchange or addition of extra technologies and innovative production steps (e.g. pre filled syringes, freeze drying) 25
Thank you Have a pleasant stay at hameln pharma