14. basan Cleanroom Forum – Outlook and Review

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GMP competence for pharmacists – the topic attracted sterile and cytostatics-producing pharmacists to Kelsterbach in May. These pharmacists are under pressure due to the requirements of the new Pharmacy Operating Regulations (§ 35 ApBetrO). Renowned experts from authorities and practice shared their knowledge for implementing the new regulations. The event showed: pharmacies desire a partner who can provide competent advice on cleanroom issues and a tailored product and service portfolio. Best of all: everything from a single source. With basan as a full-service provider for controlled environments and VWR International with its quality portfolio for microbiological monitoring, the pharmacy in sterile production has competent service partners at its side in the face of new regulatory challenges.

For cytostatics-producing pharmacies, the requirements regarding spatial and structural processes are becoming stricter. In the future, pharmacies must produce in clean rooms, which entails high demands for consulting, training, and restructuring. Practical experience shows: there are no standard solutions. New processes must be planned and implemented, and a suitable product portfolio must be found. Each pharmacy's situation is different. The requirements of various regional authorities in implementing the new ApBetrO differ, and each pharmacy has a unique profile in terms of cleanroom equipment and process workflows in sterile production.

Competent consulting and a broad portfolio of products and services are therefore qualities that pharmacies expect from their service providers. basan GmbH, as one of the leading providers of cleanroom products and services, precisely meets these requirements:

• Reusable clothing and clothing concepts including decontamination and leasing: With Quantus®, the company offers a clothing concept that includes a variety of high-quality and innovative fabric qualities for every need. Several factors play a role in selecting the clothing concept – from the requirements of the cleanroom class to compliance factors for staff.
• Cleaning / Disinfection and Hygiene Management: There are no standard solutions in the area of cleaning and disinfection either. The company develops customized hygiene concepts and plans according to existing cleaning equipment and products: for compliant and safe cleaning in sterile production.
• Disposable items: cloths and swabs, gloves, etc.: The company also has a full range of reputable suppliers for safe supply.
• Facilities, technical equipment, and personnel pass-through concepts: The company supports the planning and outfitting of personnel pass-throughs.
• Staff training: basan employees are cleanroom experts and can train staff for safe processes.

The 14th basan Cleanroom Forum demonstrated: pharmacies are very open to the challenges posed by the new ApBetrO. However, they also have a great need for advice, as they need to adapt their sterile production. This means building staff competence and restructuring processes and systems. Due to the ongoing high demand, a follow-up event will take place: The 15th basan Cleanroom Forum: "The new Pharmacy Operating Regulations (§ 35 ApBetrO) – Being prepared for the future" on November 12 + 13, 2013, at the Cleanroom Academy Leipzig.