Lounges – Cleanroom Processes

Exchange with our experts on current topics in the industry and take part in our presentations.rnrnWe will also show you exciting live demos at our booth!

Presentations and live demos

• Flexible production of pharmaceuticals in small quantities

  u003cimg class=u0022alignnone size-medium wp-image-3940u0022 src=u0022https://skan.com/wp-content/uploads/skan-variosys-isolator-adjustable-automating-GMP-300×182.pngu0022 alt=u0022the VarioSys isolator is modular according to your needsu0022 width=u0022300u0022 height=u0022182u0022 /u003ernrnThe future will bring a larger number of active ingredients that have to be manufactured in smaller quantities down to the patient-specific number of 1 that must be prepared and aseptically filled efficiently on an industrial scale. Here the improved and further developed version of a flexible adaptable machine and Isolator concept is presented with executed examples and discussed using various processes.rnrn- Packaging formats and quantitiesrn- Overall concept of a flexible manufacturing plantrn- Pesign variantsrn- Examples

• Sterility testing in aseptic manufacturing

  u003cimg class=u0022alignnone size-medium wp-image-2082u0022 src=u0022https://skan.com/wp-content/uploads/skanfog-spectra-isolator-sterile-chamber-300×182.pngu0022 alt=u0022Manipulation of chemicals in a sterile chamberu0022 width=u0022300u0022 height=u0022182u0022 /u003ernrnPerforming the sterile testing process in isolators as part of the manufacturing process is established state of the art. In addition to ergonomic and design-specific detailed solutions in the isolator, the process and the individual steps play a decisive role in carrying out a reliable and meaningful sterile test.rnrn- Regulatory requirementsrn- Design typesrn- Design objectsrn- Examples

• Production of toxic substances in the isolator

  u003cimg class=u0022alignnone size-medium wp-image-11034u0022 src=u0022https://skan.com/wp-content/uploads/c_skan-customized-isolator-technology-production-filling-lines-regulations-automation-240×300.jpgu0022 alt=u0022Maßgeschneiderte Isolatortechnik von SKANu0022 width=u0022240u0022 height=u0022300u0022 /u003ernrnIn biopharmaceutical manufacturing, the trend is towards the manufacture of new oncology products such as ADCs u0022antibody drug conjugatesu0022 or in the field of regenerative medicine such as genes and immune therapies. Most of these pharmaceutical products are combination products that also contain a highly active substance. These highly active substances require a new form of employee protection as well as higher requirements for cleaning when changing products.rnrn- Trends in Bio and Pharma Technology ADCs/ ATMPsrn- Implementation of employee protection in aseptic productionrn- GMP cleaning and avoidance of cross contaminationrn- Requirements for isolators in aseptic production

• Fast, robust and effective H2O2 Decontamination cycles

  u003cimg class=u0022alignnone size-medium wp-image-28753u0022 src=u0022https://skan.com/wp-content/uploads/Eventpic_MBV_Viable_monitoring_isolator-221×300.jpgu0022 alt=u0022u0022 width=u0022221u0022 height=u0022300u0022 /u003ernrnThough the H2O2 decontamination is a well established Process in the pharmaceutical industry, there are a lot of theoretical and practical points to consider. Some of them are well known and obvious, but still not considered in the design of modern Isolators, others depend highly on the knowledge, experience and practical skills of the of the team performing qualification and daily use. Here both aspects will be treatedrnrn- H2O2 Decontaminationrn- Cycle Developmentrn- Design Specificationrn- Methodic Aproachrn- Practical Examples

• Retrofit of sterility test isolators and filling lines

  u003cimg class=u0022alignnone size-medium wp-image-26470u0022 src=u0022https://skan.com/wp-content/uploads/Steritest_Retrofit_10_ret-300×202.jpgu0022 alt=u0022u0022 width=u0022300u0022 height=u0022202u0022 /u003ernrnA retrofit of existing and mostly robust glass and steel construction seems an attractive and cost-saving alternative. The possibilities and limits of integrating new, up-to-date solutions are in the focus of this lecturernrn- What is a retrofit?rn- When should a Retrofit be considered for isolatorsrn- What can be donern- Advantages of a Retrofitrn- Practical Examples

• Robotic solutions in aseptic manufacturing

  u003cimg class=u0022alignnone size-medium wp-image-3048u0022 src=u0022https://skan.com/wp-content/uploads/skan-integrated-processes-robotics-pure-product-protection-300×182.pngu0022 alt=u0022SKAN’s integrated processes, customized solutions for robotic and automated systemsu0022 width=u0022300u0022 height=u0022182u0022 /u003ernrnPractical examples for robots in the pharmaceutical production in cleanroom class A. Three case studies show examples of running processes at customers and the experience behind. All projects run with different robot suppliers and processes.rnrn- Process for filling and sealing closed vialsrn- Process for unpacking RTU packaging materialsrn- Process with four GT, autoclaves and breakers

• Plastics and packaging in isolators

  u003cimg class=u0022alignnone size-medium wp-image-7663u0022 src=u0022https://skan.com/wp-content/uploads/skanfog-spectra-anwendung-1-300×256.jpgu0022 alt=u0022Mitarbeiterin sitzt an der skanfog® spectrau0022 width=u0022300u0022 height=u0022256u0022 /u003ernrnThe packaging materials used and the prodcut make an elementary contribution to the loading of an isolator. When developing and implementing a robust and functional decontamination cycle using H2O2, the user should be aware of the nature of these materials. Options for determining the material or product behaviour with respect to H2O2, including individual process parameters, are discussed here.rnrn- Penetration u0026amp; adsorption of H2o2 in packagingrn- Sufficient flushing time for desorptionrn- H2o2 accumulation in the productrn- Process-dependent material testsrn- Standardized analysis methods

• Risk minimization through correct glove management

  u003cimg class=u0022alignnone size-medium wp-image-8883u0022 src=u0022https://skan.com/wp-content/uploads/thumbnail-video_wirelessgt-2-740x450x2-300×182.jpgu0022 alt=u0022WirelessGT 2 Prozess | SKAN 1:45 WirelessGT 2 Prozess | SKANu0022 width=u0022300u0022 height=u0022182u0022 /u003ernrnGloves are still the most proven option for manipulation within isolators, barrier and other systems. However, they also carry the greatest risk for the integrity of these applications. Mistaken handling, poor maintenance or inadequate monitoring can cause leaks that can allow microorganism to enter. It is therefore important to use a suitable glove management program to minimize the risk considerably. The company SKAN AG is therefore concerned with the holistic process of gloves, which goes far beyond mere physical testing.rnrn- Requirements and Challengesrn- PDA study for different hole sizesrn- Influences for a good glove qualityrn- Typical functions of a glove testing devicern- Necessary activities

• Fill u0026 Finish – Different filling modules u0022Ready to Useu0022

  u003cimg class=u0022alignnone size-medium wp-image-3940u0022 src=u0022https://skan.com/wp-content/uploads/skan-variosys-isolator-adjustable-automating-GMP-300×182.pngu0022 alt=u0022the VarioSys isolator is modular according to your needsu0022 width=u0022300u0022 height=u0022182u0022 /u003ernrnFlexibility in process control in aseptic production is the trend of the future. Increasingly smaller batch sizes and fast changeover times, for example to switch from filling a vial to filling a syringe, are the requirements in development as well as in production. The VarioSys system shows how this was successfully implementedrnrn- Sterile fillingrn- Fill-Finishrn- Modular designrn- High potent substancesrn- Packaging

• Innovative concept for aseptic-toxic filling

  u003cimg class=u0022alignnone size-medium wp-image-10694u0022 src=u0022https://skan.com/wp-content/uploads/f_skan-integra-filling-line-vial-processing-fast-efficient-221×300.jpgu0022 alt=u0022u0022 width=u0022221u0022 height=u0022300u0022 /u003ernrnAn innovative, aseptic-toxic filling concept is presented, in which the filling line merges with the isolator and is viewed as one unit. Optimum usability, employee protection and cleanability were the focus of development.rnrn- Requirements and Challengesrn- Requirements for occupational safetyrn- Optimized design for best cleanabilityrn- Technical realisation

• Live demo at booth: Fast decontamination in a sterility testing isolator

  u003cimg class=u0022alignnone size-medium wp-image-10720u0022 src=u0022https://skan.com/wp-content/uploads/spectra-2023-isolator-technology-221×300.jpgu0022 alt=u0022u0022 width=u0022221u0022 height=u0022300u0022 /u003ernrnPerforming the sterile test process in isolators as part of the manufacturing process is established state of the art. In addition to ergonomic and design-specific detailed solutions in the isolator, the process and the individual steps play a decisive role in carrying out a reliable and meaningful sterile test.rnrn- regulatory Requirementsrn- Design typesrn- Design objectsrn- Examples

• Live demo at booth: Glove Test as Part of Plant Safety

  u003cimg class=u0022alignnone size-medium wp-image-3981u0022 src=u0022https://skan.com/wp-content/uploads/skan-wireless-glove-tester-2-safety-certified-gmp-300×182.pngu0022 alt=u0022SKAN’s WIreless GT 2 is highly certified, gmp compliant and so a guarantee of safety u0022 width=u0022300u0022 height=u0022182u0022 /u003ernrnGloves are still the most proven option for manipulation within isolators, barrier and other systems. However, they also carry the greatest risk for the integrity of these applications. Mistaken handling, poor maintenance or inadequate monitoring can cause leaks that can allow microorganism to enter. It is therefore importatn to use a suitable glove management program to minimize the risk considerably.rnrn- Requirements and Challengesrn- PDA study for different hole sizesrn- Influences for a good glove qualityrn- Typical functions of a glove testing devicern- Necessary activities

• Live demo at booth: Flexible production of pharmaceuticals in small quantities

  u003cimg class=u0022alignnone size-medium wp-image-10715u0022 src=u0022https://skan.com/wp-content/uploads/f_skan-variosys-isolator-adaptative-exchangeable-packaging-221×300.jpgu0022 alt=u0022u0022 width=u0022221u0022 height=u0022300u0022 /u003ernrnThe future will bring a larger number of active ingredients that have to be produced in smaller quantities, down to a patient-specific quantity of 1, which has to be prepared efficiently on an industrial scale. The lecture shows a variably adaptable machine and insulation concept with examplesrnrn- packaging formats and quantitiesrn- Overall concept of a flexible manufacturing plantrn- design variantsrn- Realised examples