PHARMACEUTICAL, MEDICAL & PLASTIC TECHNOLOGY A successful symbiosis All-in-one solutions for the development and production Design Guidelines Validation

EDITORIAL DI Dr. Friedrich Kastner CEO / Managing Partner COLLIN Lab & Pilot Solutions GmbH Dear Readers, In recent years, our sector has been criticized unjustly, however, in some cases also justly. Many media reportings have reinforced the opinion and image formation of the broad public. However, especially the last year showed to many people how important plastics are in our life! Starting with protective shields, masks, protective clothing, breathing hoses, injections right through to closing caps for vaccination ampullae. All these products are made of plastics and nobody wants to live without...

PHARMACEUTICAL, MEDICAL AND PLASTIC TECHNOLOGY 3.1, Source: SPECTARIS, Statistisches Bundesamt, Eurostat Author: Dr.-Ing. Franz Grajewski In 2019, the global market for medical products included 445.5 Mrd. $, with a growth of 5.6%. 39.2% of it represent North America, 27.9% Europe, followed by Asia / Pacific with 25.9% /1/. Including 33.4 Mrd. $ generated by Germany, see image 3.1, /1/. It is remarkable that in this sector, there are mainly medium-sized companies and that R & D with 9% is well above the average of German industry. The reason for this high percentage of KUM in this sector is probably...

► Wide range of process temperatures (RT up to 300°C) ► Exact temperature control in each heating zone ► Short residual times in each process step ► Short product change times ► Stable, stationary, continuous processes ► Constant product quality during the entire production period show significant disadvantages regarding homogeneity of the distribution within the product and quality of the product from batch to batch. In order to overcome these problems, considerable economical and organizational efforts are necessary. Already at a very early stage, industry and approval agency have recognized...

Bioresorbable and biocidal compounds First, in the early 1970s, bioresorbable materials were used in surgery as suture material. Still today, that is an important field of application. The materials used today are PolyL-lac-tide (PLLA) and Polylactide-co-gly-colide (PLGA), Poly DL Lactide (PDLLA) /5/. One of the most important advantages of the implants, degradable by the human body, is that after healing, the surgical removal of the implant is not needed. However, the polymer materials of today do still have an essential disadvantage compared with other materials. The tensile strength is not...

The images with a selection of multi-lumen hoses show further examples for the challenges of the machine manufacturer but also of the extruding company. In addition to the desire for several channels in one hose, there are also requirements for changing mechanical characteristics in axial direction of the hose. These are the variation of the bending stiffness and strength in radial direction. This is achieved by positioning layers of different numbers and thicknesses in a fixed sequence along the hose. State of the art is that hoses with the required diameters are extruded. Then, these are, depending...

The materials used comprise the full spectrum of materials of which films can be extruded. At this point, the entirety of requirements cannot be described. This can only be achieved by coextrusion. The trend goes up to 11 layers in one film. Correspondingly, the line for the production is very complex. Furthermore, cleanroom suitability and high flexibility for product changes are important since small lot sizes must often be available very quickly. ► Defined barrier characteristics against different media The COLLIN Lab & Pilot Solutions technology for flat films and blown films is exactly in...

Companies, which are active in the medical and pharmaceutical sector have to receive and periodically present high-quality and organizational standards. Since the mid-1990s, quality management systems according to ISO 9001 have been introduced and are now established as standard tool for controlling the quality of all processes of a company. In 2009, COLLIN Lab & Pilot Solutions proved to have implemented the regulations of ISO 9001. Since then, all departments of the company act accordingly. ► Design reviews, from a certain design progress with the customer ► FMEA (Failure Mode and Effects Analysis)...

Material Specification Drawings, Parts Lists Performance Specification FDS, HDS, SDS IQ Test Report OQ Test Report PQ Test Report Product Validation Report COLLIN Lab & Pilot Solutions has a specially trained team to follow the FDA guidelines in the phases ► documentation for the manufacture of pharmaceutical and medical extrusion lines. The basis for that is the illustrated ,Validation Master Plan “VMP (taken /9/). The VMP describes procedure and responsibility during the line qualification as well as the process validation. Moreover, it describes the responsibilities, definition of the validation...

The design qualification contains the function qualification, hardware specification (electr.), software specification as well as all drawings and parts lists. The following qualification scheme /9/ shows the basic and general procedure from design qualification up to product qualification. The qualification guarantees that the line and the process have been realized in accordance with the specifications and that the requirements of the requirements specification are fulfilled permanently. Prior to performing, qualification and validation plan have to be approved by signatures after fixing. ■...

COLLINLAB & PILOT SOLUTIONS DESIGN GUIDELINE ACCORDING TO GMP The design of our lines for the medical sector is subject to strict internal rules. These comprise the clean-room suitability (class 7 and 8), easy access to the line components and reliable cleaning, software and control. The requirements according to DIN ISO EN 14644-1 require a minimization of the generation of particles by lines operated in the cleanroom. Essentially, that involves the avoidance of abrasion, dust generation, exhaust generation, etc. That results in considerable, partially very expensive measures at the machines....