Test methods
Necessity
Definitions
The importance of an efficient WFI distribution circuit design
**Overview:** The presentation covers the importance of efficient WFI distribution loop design in pharmaceutical manufacturing for safety, sterility and sustainability. **Main importance of efficient WFI distribution loop design** - WFI is critical to pharma production and requires strict sterility for patient safety. - Multistage distillation (MED), vapor compression (VC) and ambient WFI (AWFI) have specific advantages and disadvantages. - Thermal production methods ensure optimal [...]
Annex 1 safely through the jungle of requirements
For many manufacturers, the requirements of Annex 1 initially seem like an impenetrable jungle of paragraphs and processes. We are your GPS into the regulations. Three professionals - one plan! From practice for practice, we guide you through the jungle with well-founded insights into the development of a GMP-compliant hygiene concept that not only shines on paper. We [...]
Still frustrated with paper logbooks? We have a solution!
Paper-based records are still used in cleanrooms. This often includes forms, checklists, and logbooks, as well as printouts generated by simple instruments or reports from standalone systems. These may also contain gaps in data integrity, making it necessary to print them out, annotate them, and sign them. For […]
Recycling of protective clothing materials
Sustainability and the careful use of our planet's resources are becoming increasingly important. DuPont makes an important contribution to this with its recycling program for Tyvek and Tyvek IsoClean protective clothing materials. The presentation will look at the different types of protective clothing materials and their recycling options. The possibilities and processes for recycling Tyvek are presented as examples [...]
Protective clothing when handling hazardous substances in the cleanroom
When handling hazardous substances (e.g. CMR drugs, API, HPAPI, ...), 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 (disposable and reusable garments), deals with filtration efficiency and protection against hazardous substances (penetration, permeation), the GMP-compliant manufacture and packaging of cleanroom garments and possible recycling [...].
Tyvek IsoClean - Certified cleanroom protective clothing
DuPont knows that you need to do everything you can to reduce the risk of contamination in your controlled environments. DuPont™ Tyvek® coveralls have long been used in cleanrooms because they provide an excellent barrier against particles, microorganisms and liquids. They offer an ideal balance of protection, durability, comfort and contamination control. They are available in many styles for different applications [...]
Maximum visualization of contamination
At this year's event, the COWA cleanroom experts will provide insights into the training methods where staff can gain their own experience of contamination control.