Advantages of the electronic Bowie & Dick test
The electronic Bowie & Dick test offers several advantages over the traditional Bowie & Dick test paper. In this presentation, we will discuss the following points: 1. greater accuracy Electronic tests capture precise measurement data during the sterilization cycle. This allows them to detect deviations that are difficult to detect with the naked eye on an indicator paper. 2. data recording Electronic devices store [...]
Risk identification in steam supply according to GMP
Steam is often considered sterile and safe for the product per se. But as with all other media, there is good practice to minimize risks. Guidelines, laws and regulations only provide general advice on how to design and operate systems. One principle of good manufacturing practice is risk management with [...]
WFI design - how to deal with ChP changes?
Planning a new water for injection (WFI) system requires careful consideration to ensure compliance with regulatory requirements, including the Chinese Pharmacopoeia (ChP). While current guidelines mandate compliance with existing standards, a foreseeable change to allow membrane-based production and cold storage opens up potential for system optimization. This presentation will highlight how to prepare for this changing [...]
PPE in the cleanroom - balance between protection and sustainability
The design of personal protective equipment (PPE) for cleanroom areas must meet different protection requirements in equal measure. Chapter 7 of GMP Annex 1 in its updated form lists specifications for cleanroom garments, which mainly revolve around the protection of the products to be manufactured and the integrity of the controlled areas. Personal protection when handling products and working materials that pose a risk [...]
Fast track for new pharmaceutical and biotech factories
The pharmaceutical industry is developing new and more efficient active pharmaceutical ingredients (APIs) in its research and development centers. Time-to-market is one of the most important requirements for new pharmaceutical products, especially for new APIs. Fast and reliable planning and project realization strategies are crucial for the timely creation of the corresponding production capacities and successful, high-quality market launch of new drugs Pre-planned, prefabricated and [...]
GMP Annex 1 in pharmacies - Quo vadis, safety cabinet?
Two years after its publication, the interpretation of technical specifications from Annex 1 of the GMP guideline is still ongoing. The debate has now reached pharmacies and manufacturing companies, where parenteral preparations are typically made using safety cabinets. The suitability of these devices as containment for the manufacture of individual drug preparations or small batches is still the subject of controversy. How [...]
Case Study: Structured planning of biotech plants
The biotechnology sector is dynamically developing new products for pharmaceuticals, food supplements, foodstuffs and bio-based chemicals. These usually need to be produced very quickly, sometimes while product and process development is still ongoing, in market launch quantities and then quickly ramped up to large capacity. Fast and reliable scaling-up methods from laboratory to pilot scale to the transfer to commercial production are [...]
Risk management and contamination control interface
The implementation of a contamination control strategy (CCS) in accordance with Annex 1 brings a number of benefits and requirements for the pharmaceutical industry. The strategy ensures stringent control over the entire manufacturing process, which leads to increased safety and quality of pharmaceutical products and defines clear requirements that meet regulatory standards. The requirement [...]
Current developments and innovations in cleanroom measurement technology
The qualification of cleanrooms and clean air systems includes the entire assessment process for compliance with the relevant normative requirements for the intended use of typical trades. A decisive component of this qualification process is the application of EN ISO 14644 and its harmonization - including the corresponding particulate limit values - with Annex 1 in the EU GMP [...].
Online bacterial count monitoring of pharmaceutical water
Here we present the latest developments in microbiological monitoring of systems for the production of pharmaceutical water. With the help of online measurements, processes can be optimized, negative developments detected at an early stage and errors avoided. Various technologies for monitoring microbial counts are available on the market. Each has its strengths and weaknesses. Flow cytometry offers decisive advantages [...]