Technology transfer - Planning for success
Almost every pharmaceutical company is confronted with the issue of technology transfer sooner or later. Regardless of whether this involves products, processes or knowledge, the transfer from a company (sending unit) to the receiving unit must be traceable and controlled at all times. A large number of regulatory principles provide the framework and direction for this. [...]
Online TOC analysis according to USP and EP 2.2.44
The monograph "Water for Injection" (WFI) of the European Pharmacopoeia Ph. Eur. has been revised and no longer requires the production of WFI by distillation. WFI may now also be produced cold using alternative methods (reverse osmosis, electrodeionization). The advantages for operators of production, storage and distribution systems for pharmaceutical water are significantly lower operating costs. Cold production, [...]
Initial hygiene inspection according to VDI 6022 in cleanrooms
Ventilation and air conditioning systems are the basic prerequisite for the operation of a cleanroom. These must be professionally planned, built, maintained and inspected. Ventilation and air conditioning systems ensure that: - Only supply air with the desired air quality enters the room - The differential pressure to the neighboring rooms is maintained - The polluted room air is removed from the clean room - The employees are provided with [...]
Opposites? Hygiene and efficiency in ventilation technology.
Room air technology is an important factor in complying with hygiene requirements in cleanrooms. But what do ventilation and air conditioning solutions need to look like in order to meet the highest hygiene standards and be very efficient in operation? Are these opposites or not? The aim of this presentation is to show which aspects need to be taken into account. This will [...]
Overall qualification concept with supplier documents
Fill & finish lines for sterile dosage forms have been increasingly in demand on the market in recent years. In order to conserve internal resources at the pharmaceutical operators, it is possible to purchase qualification packages from the suppliers of the associated machines and systems; even if the responsibility for carrying out the qualification to meet the high regulatory requirements is [...]
Energy efficiency in cleanrooms
Operating cleanrooms requires expenditure that is reflected in the operating costs. Part of the operating costs of cleanrooms is due to energy costs. Operating a cleanroom requires electricity, heating and cooling. It is in the nature of things that companies try to keep operating costs low. Due to the (previously) low energy prices, the high [...]
Cleanroom crane with semi-automatic system and pendulum damping
Innovation through recombination - in practice, what works better wins The product solution: The cleanroom crane with semi-automatic operation and pendulum damping is currently unrivaled in the cleanroom world and was created in several steps by applying existing technologies and elements to new areas of application. The focus is on proactively recognizing opportunities and, by combining existing [...]
The new Annex 1 & its influence on fill-finish systems
This presentation contains a brief general introduction to Annex 1 and its history. In addition to a presentation of the main changes compared to previous versions (e.g. Contamination Control Strategy), the most important factors influencing the design and implementation of new fill-finish systems will be discussed. The main topics covered include cleanroom classification, system design, air velocity measurement, first-air, glove testing, reduction of manual interventions, [...]
FactoryLayer© - "Next Generation" - GMP Monitoring
With the FactoryLayer© GMP Monitoring System FL-EMS, RETEL Neuhausen AG has a scalable GMP monitoring system that can be optimally adapted to the customer's needs. The FL-EMS system is characterized by its multidimensional scalability in the following disciplines: - Sizing: Rooms | Floors | Buildings | Campus | Company-wide - Data sources: Sensors [...]
Challenges in the processing of OEB5(+) products
This presentation provides an introduction to the topic of highly active substances (definition and difference between OEL and OEB) in order to create a uniform basic understanding. The challenges that arise for the aseptic processing of high-class OEB products will be demonstrated through realized customer projects. Typical challenges include system design, simultaneous product and operator protection, use of pressure cascades, filter systems, system cleaning [...]