Purified Water / Water For Injection - Combination system
PW and WFI share some similarities in terms of water quality requirements, system planning, monitoring and sampling. Typically, both a PW system and a WFI system are considered in the planning for bio-pharmaceutical productions - to supply the individual reference points accordingly. Due to the similarities between the two systems, the question arises whether there is a possibility [...]
Opportunities for the introduction of paperless qualification
The digital transformation has now reached every company and does not stop at qualification/validation. As a result, many companies will have to consider introducing a system that enables paperless qualification/validation in the future. With such a system, many advantages can be exploited while maintaining compliance. With [...]
Visualization of the 3D air flow with STV
Plastic articles for the aseptic fill & finish of sterile pharmaceuticals are increasingly being manufactured in ISO Class 7 cleanrooms to ensure maximum cleanliness. A cleanroom booth equipped and qualified for this purpose was analyzed using the novel Ultrasonic Sensor Tracking Velocimetry method to understand the influence of installations that potentially disturb the airflow. Detailed information on [...]
Safety & efficiency: High containment filter solutions
Avoiding contamination is crucial in pharmaceutical production. High containment technologies play a key role in preventing cross-contamination, increasing workplace safety and reducing environmental impact. This presentation will introduce the latest developments and applications specifically designed to meet the challenges of the pharmaceutical industry. We will highlight innovative strategies for the safe handling of active ingredients, [...]
Certified PPE for handling hazardous substances in cleanrooms
When handling hazardous substances (e.g. CMR drugs), certified protective clothing of the highest category III must also be worn in the cleanroom. The presentation shows the differences between the various garment materials, deals with filtration efficiency and chemical protection, GMP-compliant production and packaging of cleanroom garments and possible recycling of the materials.
HEPA and AMC filtration for cleanrooms
HEPA and AMC filtration solve the challenges of contamination control in cleanrooms. They increase process efficiency and reduce energy consumption and carbon footprint (CFP). We will show you the next generation of HEPA and molecular filters and how they support you in meeting the requirements of the relevant standards (EN 1822, ISO 14644, ISO10121). We also look at the influences [...]
A case study on microbiological contamination incidents
This presentation will discuss a case study on a recurring microbiological contamination in the manufacturing process of a sterile drug product. Due to an incorrect identification of the contaminating microorganism, the source of the contamination could not originally be determined. CAPA measures were therefore taken, which were unable to prevent recurrence of the contamination. Only through the use of more accurate and [...]
Temperature monitoring in the cloud: advantages & things to consider
There are several aspects to consider when monitoring temperatures in the cloud. Firstly, your requirements for the cloud solution must be clearly defined. GxP compliance and security are particularly crucial here. The solution provider must ensure that all regulatory requirements are met in order to guarantee the integrity of the data. The cost of cloud versus on-premises data storage should [...]
Cold chain monitoring in rooms, appliances and transportation
Monitoring the cold chain plays a crucial role in proving the efficacy of a medicine and ensuring patient safety. The top priority is always to eliminate or at least minimize any risk to patients by strictly adhering to the manufacturer's specifications and the guidelines laid down by the various authorities. The monitoring of these conditions during the [...]
UV-C decontamination in cleanrooms: Binding application.
UV-C decontamination in cleanrooms: Applications. - Decontamination by UV-C radiation in classified areas. - Introduction to UV-C - The UV-C technologies - UV-C in cleanrooms and its applications - Integration of UV-C in cleanrooms, the methods - The keys to a successful UV-C project UV-C decontamination in cleanrooms. Implementation study and realization. The effectiveness of UV-C treatments [...]