process validation Germany

...Process validation refers to the demonstration that a process meets the requirements for its process results.

...With Dypipe, we guarantee you a new level of safety and flexibility in your production process for viscous and liquid products. The system can be equipped with various separators, connections, and mounting options that offer unparalleled flexibility, making it the perfect solution for your production line. An innovative sample insertion system ensures the validation of samples in real operating...

...supplier qualification, tool management, prototypes, fulfillment of contracts, to trouble shooting in the event of contract disruptions Logistics: from the first capacity check, milestone plan, securing deadlines, optimizing deadlines, pre-series, series start-up, securing supplies to inventory optimization Production: from production planning, process optimization, capacity management to the continuous improvement process quality assurance...

... variants (steel, aluminum, and composite materials) Analysis software Insight Professional efficiently supports engineers in automotive painting with quality assurance and process validation. Number of measurement channels: Up to 20 Temperature measurement range: -100 °C to 1,370 °C Thermocouple type: K (other types available upon request) Logger accuracy: ±0.3 °C Battery: Rechargeable NiMH (alkaline-manganese battery cartridge available as an option) Battery life: Up to 200 hours (measurement interval 1 s at 70 °C) Number of runs: Logger stores up to 10 separate runs...

... required steps have been carried out correctly. All of this is included in the schedule and ensures the quality of our services. Although every project is unique, validation plays an important role for us: it ensures that our process chains are traceable, secure and can be repeated again and again to the same high levels of quality. SCHOLPP is your partner for the entire lifespan of your technical equipment – even beyond commissioning. We can also provide maintenance services to ensure smooth production processes and 100% system availability. Our acceptance reports document that all the...

... narrow-lumen products and geometries that are difficult to penetrate, even with low concentrations of ethylene oxide. The low concentration of the active agent ensures the integrity of your medicated products. Other sterilization methods reach their performance limits here. Conditioning, sterilization, and desorption occur in a fully automated process, ensuring a technically safe and easy handling. The processes necessary for your products are verified as part of a validation. Country of origin: Germany Volume: 500 liters...

...Technologies film-Extrusion (Mono and Coex) converting manual converting of special products packaging ("bag-in-bag") GMP Principles cleanroomproduction (ISO 14644-1, class 8 and 9) Pestcontrol / HACCP- Prinziples Traceability / Validation EU-Pharmacopoe / FDA / EU 10/2011 Kontaminationsfreie Verpackung („Bag-in-Bag“), declartion of conformität ISO 9001:2008, EC-qualitycontrol, In-Process-controlm certificates continuous improvment / quality audits / training...

...The wireless TrackSense Pro data loggers are true all-rounders when it comes to temperature mapping and process validation in the fields of biotech, pharma, CDMOs, and cell & gene.

...The Datapaq AutoPaq is a customized thermal profiling system for temperature monitoring of paint, adhesive and sealant cure processes used in the automotive assembly market. Offering up to 20 channels of measurement in a single system, the AutoPaq is the perfect tool for performing detailed cure validation of new installations or optimizing existing lines for new models. With real time RF...

...We offer manufacturer-independent validation of your reprocessing processes with all common devices along the entire reprocessing chain: cleaning, disinfection, packaging, and sterilization (small sterilizers, sterilizers in the CSSD, RDG, E-RDG, conveyor and container washing systems). The entire validation process is covered by the scope of our accreditation. All activities, including...

...To maintain consistent quality in the processing of medical devices, minimum requirements are set for the characteristics of the equipment used in the process.

... transport systems. How do you benefit? We support you with design consulting for your components, from preliminary tests and test series to process validation and integration into an MES system. Additionally, GEFASOFT takes care of the optimal design of the laser system.

... Agitator supported at the rear, with externally exchangeable mechanical seal Entirely welded agitator design, without any bolts, without pockets and with all edges rounded for good cleanability Minimal build depth, thus very good accessibility for inspection and cleaning purposes Excellent cleanability using CIP systems, simple validation Available with separating wall between process and mechanical areas Double mechanical seal, externally interchangeable, dry running contacting or non-contacting lift-off type seals as well as liquid lubricated seals...

...In order for a student card to be valid, it must be validated at a validation station at the beginning of each semester. A visible validity imprint, degree program, faculty, student/staff ID number, memberships in student organizations, sports club eligibility, and more (thermally) will be printed on the validation strip (e.g., TRW strip). The student inserts the student ID card into the slot of the validation station, and after a short time, the validated ID card is returned. This validation process is automated. For more information, please refer to the product sheet.

...Process development and validation of research results Reverse engineering and cost optimization Design of devices and components CAD creation of drawings and bill of materials Hardware and software development Concept validation in practice Simulation models...

... also ideal for tool validation and casting small series of metal components. TetraShell is a process for creating extremely lightweight models in stereolithography. It is used by foundries to produce a ceramic shell for metal casting. The TetraShell software converts a solid 3D design file into a hollow model made of a very thin outer layer, reinforced by an inner tetrahedral structure. The lightweight structure prevents the ceramic shell from being damaged by thermal expansion.

... used in multi-shift operation with high throughput speed. Highest precision of the print image registration on convex, round or flat parts by using the pad printing process, one to multicolor, or by using the ALFALAS® laser marking process goes without saying and meets the high standards for medical products. Process monitoring by using the latest camera systems as well as their validation will secure your production and the health of the patients. Application fields:various Customized solution development:yes...

...Parameterization of the cleaning process in our application laboratories, design and implementation of machines and systems, customized automation solutions. Cleanroom solutions in the operational area of the system or integration into existing cleanrooms, process control and monitoring for quality assurance and process validation, cleaning agents and water treatment, service and maintenance of the systems, training and instruction of employees.

...The SITRANS TS300 series is designed for use in hygienic applications and offers a wide range of industry-standard process connections. The advantages of the clamp-on technology are particularly evident with small pipe diameters: no welding and no welding validation, no disruption to the process, preservation of pigging capability, easy disassembly for recalibration, all while maintaining a measurement accuracy comparable to that of built-in sensors.

... sealing process (multi band) - Seal seam width of 15 mm - Manual edge adjustment - Automatic sealing temperature adjustment - Speed of 10 m/min - Available with integrated printer (optional) - Warranty: 2 years * Includes VIP service package (without validation) in the Berlin/Brandenburg area (other locations upon request). For more details, please refer to this pdf file: Mocom Hot Sealing Machines Brochure Item No.: M7B240000 (without printer), M7B240001 (with printer)...

... components with long life time • Easy calibration transfer to other Bruker lab, at-line or process spectrometers • Fully cGMP and 21 CFR Part 11 compliant, supports validation according to USP and Ph.Eur 2.2.40...

... stationary container handling systems are equipped with robust forks and a weighing unit, if required. Container lifter with grinder lift column Type FTHSK 1000 G5-2 lifting weight 1000 kg height 6 m Design: lifting, inverting, swivelling, grinding - all motorized Container Wash Station high pressure, 150 bar warm-cold water rotating injection nozzle validation possible Container lifter for rectangular containers lift and swivel column Type FTHS 1000 G4 loads up to 1000 kg column height 5.0 m Design: motorized lift manual swivel Emptying and charge weighing Emptying and charge weighing system for..

... – all without any label design experience. ° Design like a pro – even as a beginner ° Pre-made compliance labels ° All the help you need ° Dynamic text objects ° All the languages you need ° Powerful, unique features ° Database connections ° Data validation, formatting, and processing...

...), alphanumeric characters, logos, and inscriptions are reliably and highly precisely marked with the fiber lasers. The optionally integrated camera system in the marking head ensures zero-error quality and process reliability through automatic optical validation and verification steps. Power class: 10/20/30/50W Wavelength: 1064nm...

... manoeuver. The integrated printer documents the individually executed steps of the washing cycle. Outside cleaning is done manually, and completes the entire semi-automatic washing process. The system can be extended to a validation-capable, separate drying station in order to reduce production container downtimes. As an alternative, one can integrate a drying unit into the semi-automatic wash station. Flexible and easy cleaning Technical description PLC control, adhering to GAMP 5 guidelines with password and recipe management up to CFR 21 part 11 implementation Cleaning cover with...

... marking. To date, we have successfully completed well over 400 CE markings. Our services at a glance: - CE marking, conformity assessments according to the Machinery Directive 2006/42/EC, EMC Directive 2014/30/EU, and Low Voltage Directive 2014/35/EU, as well as others upon request and inspections according to DGUV Regulation 3 (formerly BGV A3), DIN VDE 0701 – 0702, DIN EN 60204-1 - Validation to determine the safety of the machine according to DIN EN ISO 13849-1/2...

... of a completely new manufacturing approach. Design with load simulation and optimization for injection molding. Validation of the sample series. Delivery of the molds. Series launch. The customer not only received an improved product. Moreover, a knowledge transfer occurred during the introduction of series production. The manufacturing process has benefited far beyond the production of the needle comb.

... the perfect fit for you are: - Work reliably and transparently: Computer System Validation (CSV) - Meet regulations: Compliance fulfillment - Ensure safety: Unique Device Identification (UDI) and Serialization - Process data easily with a click: Data exchange - Keep all batches under control: Batch management - Maximum quality: Quality inspection - Save time, money, and paper: Electronic signature...

...Clean Process GmbH has been a supplier and partner for air filters, cleanroom filters, and activated carbon since 2016. The founders are Jens and Nicole Müller (currently management). - We support you in the commissioning and validation of your cleanroom. - Upon request, we create maintenance plans and supply replacement filter media. - We often design and build special filters & filter...

... interest of customer benefit, of course. If you have tasks related to drying (powder drying or spray drying), agglomeration, or evaporation – with our state-of-the-art production facilities, we at MEGGLE can realize your individual and perhaps even the most extraordinary customer requests in contract manufacturing from various industries. This is also confirmed by our certifications according to ISO 9001:2015, ISO 14001:2004, FAMI-QS, HACCP, IPEC GMP, EXCiPACT. And process/cleaning validation for pharmaceutical products is also possible within the framework of contract manufacturing.