Support in pharmaceutical microbiology for the implementation of legal requirements
AKuSo GmbH is your competent partner for consulting in the field of pharmaceutical microbiology / environmental monitoring for the implementation of legal requirements.
Support in pharmaceutical microbiology for the implementation of legal requirements
AKuSo GmbH is your competent partner for consulting in the field of pharmaceutical microbiology / environmental monitoring for the implementation of legal requirements.
Competent partner
- in the field of microbiology
The implementation of legal requirements in the field of pharmaceutical microbiology is a complex topic. Through my many years of experience in the industry, I have become acquainted with and accompanied the most diverse approaches of companies to the possible implementations. For example, the establishment of a microbiology laboratory or the development of monitoring concepts for ultra-clean media and cleanrooms. I also offer training for various topics in the field of microbiology. With my professional expertise, I offer a solution adapted to you and your company to effectively implement legal requirements, so that you are as efficient and compliant as possible in your daily work in the plant and in the laboratory.
Your contact person
Our competences
Establishment of microbiology laboratories
Laboratories are built with a number of considerations in mind. These include laboratory needs, laboratory safety, and laboratory efficiency and effectiveness.
Safety is of paramount importance in the design of a microbiology laboratory. There should also be a division into areas where work is done with microorganisms and with samples. Consideration should also be given to the installation of chemical-physical analysis equipment, which plays a role in the field of microbiological monitoring of ultrapure media.
Safety is of paramount importance in the design of a microbiology laboratory. There should also be a division into areas where work is done with microorganisms and with samples. Consideration should also be given to the installation of chemical-physical analysis equipment, which plays a role in the field of microbiological monitoring of ultrapure media.
Concept revision
I revise monitoring concepts of cleanrooms and clean media for your company.
I support you and your company to develop solutions that can be successful in the long term. My experience has been shaped by working for well-known companies with extensive microbiological know-how, so I can give you a good idea of what can work and is compliant.
I support you and your company to develop solutions that can be successful in the long term. My experience has been shaped by working for well-known companies with extensive microbiological know-how, so I can give you a good idea of what can work and is compliant.
Employee training
Training of microbiology staff is an important process that should be carried out by all pharmaceutical companies. This process is necessary to ensure that staff are familiar with the latest techniques and practices in the field, as well as the basics of GMP in the microbiology laboratory.
Staff training in microbiology will also help identify gaps in staff knowledge and skills and address them according to needs, helping staff to better perform their duties.
Staff training in microbiology will also help identify gaps in staff knowledge and skills and address them according to needs, helping staff to better perform their duties.
Training microbiology for non-microbiologists
Non-microbiologists in pharmaceutical companies often wonder:
- Why all this?
- What is taking so long here?
- Why is it so expensive?
In this training I show the basics and create understanding for this area of quality control and quality assurance.
- Why all this?
- What is taking so long here?
- Why is it so expensive?
In this training I show the basics and create understanding for this area of quality control and quality assurance.
Training with education providers
For example, at www.swisscleanroomconcept.ch for water systems qualification.
Qualification of clean rooms and / or ultrapure media
A clean room is a space specifically designed to reduce the number of particles in the air, the particles in turn are carriers of microorganisms, which are then subsequently also reduced. The air in a clean room is filtered by an air purification system and provided with a certain temperature and humidity. The surfaces are thus kept free of additional dirt, dust and other contaminants from the ambient air. The cleaning and disinfection of cleanrooms is a subsequent topic there.
Cleanrooms are the basis of pharmaceutical production, I can offer you my consulting expertise in the conceptual area as well as in the execution of risk analyses for the qualification of cleanrooms.
Cleanrooms are the basis of pharmaceutical production, I can offer you my consulting expertise in the conceptual area as well as in the execution of risk analyses for the qualification of cleanrooms.
Ultrapure media (ultrapure water, steam, gas)
Water treatment involves the removal of all types of impurities from the water. This process starts with the use of pre-filters, then ion exchange resins are used to soften the water. Further, reverse osmosis membranes are used to produce Purified Water and/or Water for Injection. Water for Injection can also be produced via distillation. In cold systems, ozone is used in the water system/loop to keep the number of microorganisms under control. Also chemical and physical parameters are determined.Hot systems in a certain temperature range are considered self-sanitizing, there, in addition to the number of bacteria, the concentration of bacteria endotoxins is relevant.
Ultrapure steam and process gases such as compressed air or nitrogen are other ultrapure media systems that must be monitored. A risk analysis based on the use of the medium is performed to prepare the sampling plans of ultrapure media systems.
Ultrapure steam and process gases such as compressed air or nitrogen are other ultrapure media systems that must be monitored. A risk analysis based on the use of the medium is performed to prepare the sampling plans of ultrapure media systems.
Routine monitoring of the clean rooms and clean media
The monitoring of clean rooms and ultra-clean media is a daily routine.
Monitoring of the cleanrooms is ensured by means of particle measuring devices as well as microbiological procedures such as air sampling, sedimentation plates, surface bacterial count determination with RODAC or continuous procedures.
In order to determine the status of the respective systems, the obtained analysis data is trending. These trends must also meet the requirements and from the obtained data the warning values are calculated.
Monitoring of the cleanrooms is ensured by means of particle measuring devices as well as microbiological procedures such as air sampling, sedimentation plates, surface bacterial count determination with RODAC or continuous procedures.
In order to determine the status of the respective systems, the obtained analysis data is trending. These trends must also meet the requirements and from the obtained data the warning values are calculated.
Process
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Contact us
Contact me without obligation by mail, phone or via the contact form.02
Phone-Call
Together on the phone, we talk about your challenge and discuss initial possible solutions.03
Offer
After our joint discussion, you will receive an individual offer, tailored to your challenges.
04
Implementation
I will competently assist you with my expertise and support you in implementing legal requirements in the field of pharmaceutical microbiology or environmental monitoring tailored to your company.04
Feedback
Continuous feedback makes it possible to implement the specifications even more efficiently.
Learn more about me
- my vita
My professional expertise in microbiology increased continuously during the last 20 years as scientific assistant and team leader in the following companies such as:
Novartis Pharma Stein AG, CSL Lengnau AG, Lonza AG, Crucell Switzerland AG and in the cooperation on a global level in the mentioned companies and in international committees like e.g. Biophorum for the development of standardized procedures in the field of microbiological monitoring of cleanrooms.
Through my experience in different companies I am familiar with the different approaches to the challenges in the microbiological field. I was active in the field of:
– QA & QC for microbiological testing of final & intermediate products, -QA and QC for monitoring of clean media and clean rooms in pharmaceutical operations as well as
– routine and performance qualification incl. risk analysis – of ultrapure media & cleanrooms
– supported the engineering (e.g. sampling points in ultrapure media systems) and IT (setup of LIMS) in new building projects by explaining the needs from a microbiological point of view and illustrating solutions.
I now offer you this expertise with AKuSo GmbH for your projects in a solution-oriented way.
Contact us now
I would be happy to support you in the field of pharmaceutical microbiology and monitoring for cleanrooms and ultra-clean media. I look forward to hearing from you.
