Newsletter_07-2024_EN

More documents

Recommendations

Info

In particular, many companies, switching to under-isolator production, are considering the use of concentrated products for Grade C/D outdoor environments. Would you recommend their use? If so, with which procedure? Yes, there are no concerns, especially within lower grades of cleanrooms. The important point is to ensure the dilution is correct and that the correct grade of water is used. Training of personnel Personnel training: with the latest Annex 1, and the increasingly stringent rules on cleaning and disinfection, personnel training is a key point. Are there also changes in training methods with the new Annex 1? The Annex could go further with training. Appropriate training for all personnel dealing with disinfectants is vital. This training should include all relevant staff including contract personnel working within the facility. Documentation of this training is essential. All personnel should understand the importance of cGMP. For a new employee, this training could be part of their initial GMP induction. A pre-determined program of training should be in place and documented as well as a system to measure the effectiveness of the training. Personnel should all be trained in good cleaning techniques using the appropriate equipment. All staff should be provided with appropriate clothing in order to perform this operation, e.g., cleanroom clothing in manufacturing areas with adequate PPE. Procedures should also be in place if spillage occurs with any of these agents. Training programs could include: – The importance of disinfection in relation to GMP, its necessity in preventing microbial proliferation, cross contamination and the importance and significance of good disinfection routines. – The importance of the correct handling of disinfectants, whether it is during the disinfectant’s preparation, testing or use. – Basic microbiology and how contamination is transferred in the workplace. – An understanding of the properties of disinfectants and their correct application. A refresher program should also be in place, ensuring that once personnel are trained, their knowledge is kept up to date. Many companies now incorporate this into regular GMP refresher training, recommended to be undertaken on a periodic basis. Adequate documentation of these updates in an employee training record is essential. Cleaning & Disinfection in Grade C & D areas Finally, the CCS in the new Annex 1 extends to all areas at risk of contamination. Also in paragraph 4.35 it is stated that “disinfectants used in grade C and D may also be required to be sterile where determined in the CCS”. This implies increased attention also for non-sterile areas and for producers of cosmetics, ointments and biological intermediates with low bacterial load etc. For the latter, the challenge will certainly be significant. What are the essential activities to adapt? Some good practices for the adoption and use of disinfectants, in accordance with GMP, are: – Written procedures should be in place. – Responsibilities for cleaning should be assigned. Often this is interpreted as the need to have independent cleaning staff separate from those involved in product manufacture. – Staff must be trained in cleaning techniques and have a training record. – Details of cleaning frequencies, methods, equipment, and materials must be recorded in written procedures. This may relate to an approved supplier specification. – The cleaning of equipment and materials must take place at regular intervals. – Inspection of equipment for cleanliness before use should be part of routine operations. – A cleaning log should be kept. The purpose is to keep a record of the areas cleaned, agents used, and the identity of the operator. – The microorganisms isolated (the microbiota) from environmental monitoring programs should be examined for resistant strains. Some isolates from these reviews should be incorporated into disinfectant efficacy studies. – The monitoring for microbial contamination in disinfectant and detergent solutions should be periodically undertaken. – The storing of disinfectant and detergent solutions should be for defined (and short) periods. – Room use should be recorded after each operation. – There should be a technical agreement with the company who supplies the disinfectant. Ideally the disinfectants purchased should be lot tracked. – SOPs containing references to disinfectants, cleaning agents, materials and equipment used and calibration of equipment are accessible. Here the cleaning and disinfection methods are clearly defined. – The SOP should include cleaning method details e.g., wiping front to back or top to bottom with overlapping strokes. – Cleaning method, e.g., double bucket, rinsing wipe action, contact time and cleaning of cleaning materials must also be included in the – Documentation of rotation, rationale, and frequency, needs to be set out. – Cleaning logs also need to be in place and available. In compliance with GMP, cleaning and disinfection procedures should be included in any audit program as it maintains assurance that contamination control procedures are adequate and in control. Conclusions The Contamination Control Strategy underlying the new Annex 1 finds its backbone in Quality Risk Management: assessing risks on a scientific basis and offering a commensurate response to them is the real key to adapting to the new requirements. Dr. Tim Sandle is a pharmaceutical microbiologist, science writer and journalist. He is a chartered biologist and holds a first class honours degree in Applied Biology; a Masters degree in education; and has a doctorate from Keele University. AM INSTRUMENTS Via Isonzo, 1/C Phone: +39 02 8728421 email: info@aminstruments.com IT20812 Limbiate (MB) Internet: https://global.aminstruments.com/ www.reinraum.de | www.cleanroom-online.com NEWSLETTER | Edition EN 07-2024 page 6/28
Unique look behind the scenes of AT&S research The technology leader AT&S already holds almost 800 patents and was giving an insight into its R&D departments in Leoben at the “Long Night of Research” on May 24, 2024. But some things remain top secret: the new research center and Europe’s first substrate plant recently installed a high-tech machine that is unique in the world. It allows the exposure of substrate structures that are 14 times thinner than a human hair. “No photography” and “Restricted Area” – as if these signs weren’t enough, the high-tech machine is also concealed behind a plastic screen. What stands here in the protective yellow light of the clean room is the pride and joy of the R&D team at the new substrate research center “HTB3” in Leoben. From the outside, the cube-shaped machine is inconspicuous. And yet: there is no other machine like it in the world and it would cost several million euros to buy – but AT&S has been provided with it by the manufacturer as a prototype for six months for testing purposes. This provides the production company with practical data to make the device ready for series production, and the AT&S engineers have a special tool to carry out invaluable R&D analyses in parallel with production. The inner workings are spectacular: the machine is an exposure tool for lithography, a so-called Direct Imager, which can expose extremely fine structures in substrate production. In microtechnology, the micrometer is the measure of all things: 1 micrometer (1 μm) is a thousandth of a millimeter. The conductor tracks that can be produced using this exposure device are only 5 μm wide (0.005 mm). By comparison, a human hair is around 70 μm thick (0.07 mm) – and therefore 14 times wider. The team led by Leoben R&D expert Timo Schwarz has been testing the Direct Imager since May and has carried out countless analyses. The new R&D tool enables a high resolution in combination with greater depth of field, generally more configuration options, unlimited design variations and a faster, more flexible and resource-saving test phase compared to other technologies. “For the first time in Europe, we are researching the further development of our IC substrate technology under near-production conditions, creating added value for us and our partners,” Schwarz is proud of the development in Leoben. What are substrates? In simple terms, substrates are reduction couplings from printed circuit boards to the chip. They connect the tiny inputs and outputs of powerful microchips (such as in graphics cards) with the much larger structures of the printed circuit board. Today, substrates are an important basis for all forms of data processing. AT&S already holds almost 800 patents for the manufacture of IC substrates and high-tech printed circuit boards. More than a fifth of the company’s turnover is the result of the innovative strength of AT&S research. “The fact that we not only support top customers with AT&S, but are even development partners for many of them, shows the trust and appreciation that we enjoy with our technological excellence,” says AT&S Head of Research Hannes Voraberger. “Especially in Europe, a focus on research and development of highly complex microelectronics is essential to avoid becoming economically and technologically dependent.” AT&S CTO Peter Griehsnig also emphasizes the aspects of sustainability: “AT&S’s R&D activities contribute to sustainable development in two ways: Firstly, innovative tools in research work save valuable amounts of time, costs and materials, and secondly, the products created with them ensure more efficient data transmission and smart, green energy efficiency for our end customers.” AT & S Austria Technologie & Systemtechnik Aktiengesellschaft A 8700 Leoben www.reinraum.de | www.cleanroom-online.com NEWSLETTER | Edition EN 07-2024 page 7/28
Page 1 and 2: EN 07/24 Receiving ISO 3 cleanroom
Page 3 and 4: Quantum sensor improves process and
Page 5: natively a mop with a ready prepare
Page 9 and 10: industry forward and at the same ti
Page 11 and 12: „Smart power technologies“ in a
Page 13 and 14: provider of measurement instruments
Page 15 and 16: National study requires new peel ap
Page 17 and 18: tion coefficient of < 1% in the ran
Page 19 and 20: Acquisition will advance Merck’s
Page 21 and 22: Viola Schäfer, Pfeiffer Vacuum Mar
Page 23 and 24: Exhibition Grounds (Copyright: DECH
Page 25 and 26: The MEDICA START-UP COMPETITION tro
Page 27 and 28: GEMÜ butterfly valves in the GEMÜ

Newsletter_07-2024_EN

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?