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Swiss Blister Centre - Flawless drug delivery in the clean room

The Swiss Blister Centre in Zurich ensures greater safety in the dispensing of medicines in institutions such as nursing homes and homes for the elderly: personalised doses of medicines are blistered hygienically and automatically under cleanroom conditions. This relieves the nursing staff and prevents errors.

In the daily routine in medical facilities, staff are always challenged. A distraction can quickly lead to medication portions for patients not being prepared correctly, which can have life-threatening consequences. Although there are no exact figures on deaths due to incorrect medication, the risk is obvious and the number of unreported cases is presumably high. The Swiss Blister Centre ensures greater safety in the dispensing of medicines. Here, in a modern clean room, medicines are individually dosed to order and blister-packed in a tubular bag, as well as precisely labelled. In this way, deviations between prescribed and actually taken medicines are reduced to a minimum.

Three steps to more safety
Several process steps are necessary from the drug to the tubular bag. Automation plays a major role here. The three steps of deblistering, blistering and checking are central. For quality reasons, these processes take place in a class D clean room. Only medicines approved by Swissmedic, purchased from wholesalers or directly from pharmaceutical companies, serve as the starting material. In a first step, a loading robot brings the originally packaged medicines to the airlock. From there they enter the production room. Here, the medicines are unpacked before portioning. This deblistering, the most time-consuming step, is done semi-automatically. The tablets or capsules thus prepared are then filled into a designated canister and loaded into the blistering machine. Each canister contains only one medicine, because it is adapted to the respective medicine form. The blistering machine can hold up to 500 different canisters at a time. Fragile tablets or tablets cut in half, as well as tablets whose dust would contaminate the machine during production, must, however, be provided manually and placed on the machine via single tray systems.

What is usually done by the nurse is now done by the machine: the dispenser doses the correct medicine from the canisters into a plastic bag at the right time. This ensures that only the required number of tablets fall into the bag during the machine set-up process. The tablets and capsules portioned in this way represent the ration for a single intake time. They are combined in a bag, which is sealed to form a blister ready for dispensing. Within an average of 2.3 seconds, the medicines are packed into a blister in perfect order per patient and time of intake, and the bags are correctly labelled. The plastic bag film is continuously filled and rolled up, reminiscent of a film reel. Finally, the blister bags are lined up chronologically - practical and space-saving.

Identifying and labelling the blisters is particularly important for safety. According to the institution's wishes and the authorities' specifications, each individual bag is labelled in detail. The information printed includes details of the patient's name, year of birth and unit of residence, as well as the time of administration and the description of the medication with colour and shape. Each blister pouch is given a unique identification number, which enables complete tracking of product, batch and expiry date. The bags produced are individually inspected in a two-stage process. The first task is performed by a high-resolution photo-optical system. This inspects each bag and compares the contents with an image database. If parameters such as colour, shape, size and quantity match the information in the database, a specialist carries out the visual inspection in a second step. If anything is unclear, the bag is marked and then checked by hand and corrected if necessary.

Ordering via the pharmacy
After the photo-optical check, the individual orders are cut per patient and rolled up individually. After the final inspection, a specialist releases the tubular blisters for packaging and dispatch. Overnight, the wholesaler delivers the blisters to the ordering pharmacy, which is in contact with the customer. This means that less than 20 hours elapse between order placement and delivery! The pharmacy therefore plays a central role in the delivery process. Institutions such as old people's homes and nursing homes that do not have their own home pharmacy cannot order directly from the blister centre, but require a consultant pharmacy according to the law. This takes the order and delivers the blisters to the customer. When the order is placed, the medication of each individual patient is recorded electronically and approved by a specialist. This data then reaches the blister centre. As a rule, a patient's weekly requirement is blistered in accordance with the doctor's prescription and on behalf of the pharmacy. Package inserts are only available electronically; the order pharmacy is available for queries.

Clean room for hygienic blistering
The Swiss Blister Centre AG was founded in 2015 as a company of Dr. Bähler Dropa AG. A clean room facility was deliberately built for the preparation and packaging of the medicinal products in Zurich, making the Swiss Blister Centre unique in the country. Production in Switzerland's most modern blistering facility started in March 2016. "We work in a class D clean room. Although this is not yet required by the authorities, it is clearly in line with European developments," explains Franklin Schatzmann, CEO of Dr. Bähler Dropa AG. This means that the centre not only meets pharmaceutical and legal requirements, but also the highest quality standards. A modular construction system was used for the class D premises. A gallery of fully glazed cleanroom walls allows a view of the action and lets daylight stream into the production room. Transparency is very important to the operators of the blister centre in every respect: "By appointment, we are happy to receive visitors who are interested in our service," Schatzmann emphasises, "so they can see our operation for themselves." The technical cleanroom operation is monitored and secured by a fully integrated control and monitoring system. Particular attention was paid to the air exchange, as well as the process air extraction, due to the development of dust during deblistering and production.

In addition to increased safety, other advantages
"The end product matches the order 100%. This is ensured by multiple checks of the individual machines, between their interfaces and the specialised personnel," Schatzmann summarises. It is therefore obvious that the automation of medication dispensing leads to higher safety. However, the use of pre-portioned medicines brings further added value to the institutions, the patient and the pharmacy: "For institutions, the focus is on gaining efficiency and time thanks to reduced workload in the preparation process," Schatzmann explains. "This gives the nursing staff more capacity for their core competencies: nursing and care. This ultimately benefits the patient. The aspect of economic efficiency is also interesting. Schatzmann explains: "The Swiss Blister Centre usually provides the medicines as a weekly requirement. Unnecessary stocks of medicines, costs for their storage and expired products are eliminated. This is an active contribution to reducing healthcare costs." For patients in old people's homes and nursing homes, the institution usually assumes the costs for packaging. For direct customers of pharmacies, the basic insurance covers the packaging costs under certain conditions. For the patient as the end user, there are also other advantages: pre-portioning reduces responsibility and mix-ups are minimised. The tedious squeezing out of the pack or the halving of tablets is no longer necessary, and practical individual pouches are ideal for mobile users. Finally, pharmacies also benefit from the service. After all, blistered medicines are a competitive advantage and increase their appeal to institutions. Pharmacies that offer the "blistering" service gain further competence and trust in the healthcare market. In addition, the error-prone and time-consuming manual preparation of medicines for patients is no longer necessary.

Trained and qualified
As is the case for all processes in cleanrooms, only qualified personnel are allowed to work in the cleanroom. "We employ only pharmaceutical specialists with a focus on technical production as well as people with university degrees and diplomas," Schatzmann says. "Regular further training is mandatory and obligatory. The cleaning staff is provided by specialised companies." Handling personal patient data also requires a high level of data protection. The staff, like doctors or nurses, are subject to the duty of confidentiality and professional secrecy. In accordance with official regulations, the Swiss Blister Centre is supervised by Swissmedic. The processes are therefore subject to GMP regulations. Process validations and equipment qualifications are therefore a matter of course. The Swiss Blister Centre makes a major contribution to the efficiency and safety of modern drug delivery. The infrastructure in the modern clean rooms also ensures an advanced high standard of hygiene.

Further information: Schweizer Blisterzentrum AG, Binzstrasse 38, CH-8045 Zurich, Phone +41 (0)44 284 80 80, info@schweizer-blisterzentrum.ch, www.schweizer-blisterzentrum.ch

Report: Sonja Bichsel-Käser
This article was published: Contamination Control Report 1/2018

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