Influences on the effectiveness of an H2O2 deco cycle
Although H2O2 decontamination is an established process in the pharmaceutical industry, there are many theoretical and practical aspects that need to be considered. Some of them are well known and obvious but are not taken into account in the development of modern isolators, others depend to a large extent on the knowledge, experience and practical skills of the team that [...]
Robotic solutions in aseptic production
Practical example of robots in pharmaceutical production in cleanroom class A. Three case studies show examples of ongoing customer processes and the experience behind them. All projects are running with different robot manufacturers and processes. By automating processes, efficiency, product quality and production capacity can be increased. The experience gained from these projects shows that the use of robots in [...]
ATMP Manufacturing: the path to the future
In recent years, the number of approved ATMPs has grown rapidly, and the scientific development of new technologies has been just as fast. We can now treat many diseases that were previously a death sentence for patients instead. Yet, ATMPs still reach few patients, for a variety of reasons. We need to change the situation today in order to bring therapies to [...]
Requirements for the production of highly active substances
In biopharmaceutical manufacturing, the trend is towards the production of new oncology products such as ADCs (antibody drug conjugates) or in the field of regenerative medicine such as genes and immunotherapies. 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 [...]
Process safety through correct glove management
Gloves are currently still the most proven option for manipulation within isolators, barriers and other systems. However, they also pose the greatest risk to the integrity of these applications. Incorrect handling, poor maintenance or inadequate monitoring can result in leaks through which bacteria and germs can enter. It is therefore important to have a suitable glove management program [...]
Flexible aseptic pharmaceutical production of small quantities
A large number of active ingredients in biopharmaceutical production, especially for oncological applications, are antibody drug conjugates. Especially in the field of gene and immune therapies, smaller batch sizes down to patient-specific quantities of 1 are produced, which must be prepared efficiently on an industrial scale. The presentation shows a variably adaptable machine and isolation concept with executed [...]
Modern laboratory isolators for safe aseptic processes
The requirements for safe aseptic processes in the laboratory are becoming more and more stringent. In addition to carrying out sterile test processes - also with toxic products - in isolators as the established state of the art, new developments and technologies will be presented. These advances help to further improve the safety and efficiency of aseptic processes in the laboratory. The presentation [...]
Components of a modern sterile test isolator
The sterility test is part of the manufacturing process for parenterals. The GMP guidelines also prescribe this test. More than 50 years of know-how have gone into the development of the SPECTRA isolator to ensure a highly reliable and ergonomic process flow for the operator. With its many years of experience and technological progress, it helps to ensure the quality [...]
Product and employee protection with economical isolators
Isolator technology is always preferable to conventional cleanroom technology when there are stringent requirements for occupational safety or occupational safety in combination with absolute product protection. Isolator technology was initially primarily used to protect people from hazardous products, but has been expanded and optimized over time to provide product and personal protection, e.g. in [...]
Modular applications for the production of highly active substances
The future will bring a larger number of active ingredients that need to be produced in smaller quantities, right down to the patient-specific quantity of 1, which must be prepared efficiently on an industrial scale. Due to the increasing variety of active ingredients and the need to produce them in smaller quantities, it is crucial to develop efficient and adaptable production processes. The presented machine and [...]