Innovations in further training for cleanroom personnel
People's changing learning patterns and needs due to the increasing use of media are shaping a new era of learning. Online learning and flexibility in terms of location, time and learning methods are becoming increasingly important. In this context, a paradigm shift has also taken place in the cleanroom sector, leading to new approaches in continuing education. The integration [...]
GMP-compliant and efficient cleanroom measurement technology
The current provisions for the qualification of cleanliness zones in the manufacture of sterile medicinal products are set out in the current Annex 1. A crucial part of this qualification process includes the application of the classification according to EN ISO 14644 in order to ensure that measurements are carried out in compliance with the standard. Particular attention is paid to the measures from the contamination control strategy. In order to meet the requirements of the [...]
Contamination control strategy - a holistic view
The implementation of a contamination control strategy in accordance with Annex 1 brings a variety of benefits 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 guidelines that meet regulatory standards. By implementing this strategy, companies can [...]
Are there alternative barrier technologies besides insulators?
The choice between isolators and alternative barrier technologies in the context of Annex 1 depends on various factors, including the type of manufacturing, the product and the specific risks of the process. The choice proves to be a crucial step for pharmaceutical manufacturers to ensure the highest quality standards. Various factors play a central role in this decision. [...]
CCS: Annex 1 updates and warning letters from the FDA
This presentation will examine Annex I updates on cleaning, disinfection, airlock decontamination, drain cleaning, disinfectant validation and contamination controls. FDA warning letters and best practices will be discussed. Case studies of ineffective contamination control programs will be presented, providing insights for improvement. Attendees will receive a roadmap to improve their contamination control strategy and avoid regulatory allegations.
Flow measurement in cleanrooms: requirements and procedures
Directionally defined airflow in cleanrooms protects products from contamination and disruptive particles are safely removed. For this purpose, a uniform air flow from the ceiling to the floor is maintained in cleanrooms with high cleanliness classes. The monitoring range extends from 0.36 to 0.54 m/s flow velocity (EU GMP guidelines, Annex 1 in Class A). This measurement is carried out on the cleanroom side after terminal filters. [...]
Annex 1 from the perspective of the system manufacturer for RR technology
In the new Annex 1, there are a number of changes that must be observed especially for planners, installers and service providers of cleanrooms (room and airlock concepts and barrier systems) with regard to air routing, qualification and requalification. The changes in Annex 1 concern system technology (air conditioning technology), room planning (airlock concepts), the qualification and requalification of rooms to achieve and verify the [...]
Dehumidification in a clean environment
Air dehumidification in a clean environment, adsorption dehumidification, dehumidification through condensation, areas of application and limits of use The two common methods of air dehumidification in air conditioning technology are condensate dehumidification and adsorption dehumidification Which technology is used for air dehumidification to achieve the required climate parameters depends on various factors. There is no generally applicable basic rule. The basic parameters are the room temperature [...]
Reduce the cost of laundry processing to up to € 0
Companies with at least 20 employees are legally obliged to fill a certain number of their jobs with severely disabled employees. For every unfilled mandatory job, a so-called compensatory levy must be paid to the legislator every month. In short: the company pays a penalty on an ongoing basis. Get this money back from the state by awarding contracts to sheltered workshops. [...]
DECOpulse® - H2O2 bio-decontamination system
Next Generation H2O2 bio-decontamination - reliable process for highest operator and product safety. The H2O2 bio-decontamination system DECOpulse® enables robust and reliable decontamination with fast cycle times. High production times and high flexibility in pharmaceutical production are guaranteed by the fast cycle times. Due to the very low H2O2 consumption with savings of up to 65%, outgassing is very [...]