The daily routine in medical facilities is a constant challenge for staff. Distractions 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 Center ensures greater safety when dispensing medicines. Here, in the modern Cleanroom, medicines are individually dosed to order, blister-packed in a tubular bag and precisely labeled. In this way, discrepancies between the prescribed medication and the medication actually taken are reduced to a minimum.
Three steps to greater safety
Several process steps are required from the medication to the tubular bag. Automation plays a major role here. The three central steps are deblistering, blistering and checking. For quality reasons, these processes take place in a class D Cleanroom Only medicines approved by Swissmedic, obtained from wholesalers or directly from pharmaceutical companies, are used as starting material. In a first step, a loading robot brings originally packaged medicines to the airlock. From there, they are transported to the production room. Here, the medicines are unpacked before being portioned. This deblistering, the most time-consuming step, is semi-automatic. The tablets or capsules prepared in this way are then filled into a designated canister and loaded into the blistering machine. Each canister contains only one medication, as it is adapted to the respective medication form. The blistering machine can hold up to 500 different canisters at a time. However, fragile or halved tablets, as well as tablets whose dust would contaminate the machine during production, must 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 medication 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 automatic preparation process. The tablets and capsules portioned in this way represent the ration for a single intake time. They are combined in a pouch, which is sealed to form a ready-to-dispense blister. Within an average of 2.3 seconds, the medication is packed into a blister in the perfect sequence for each patient and time of intake and the pouches are correctly labeled. The plastic pouch film is continuously filled and rolled up, reminiscent of a roll of film. Finally, the blister bags are lined up chronologically – practical and space-saving.
Identifying and labeling the blister packs is particularly important for safety. Each individual pouch is labeled in detail according to the wishes of the institution and the requirements of the authorities. The printed information includes the patient’s name, year of birth and residential unit, as well as the time of administration and a description of the medication with color and shape. Each blister pack is given a unique identification number, which enables complete tracking of the product, batch and expiry date. The bags produced are checked individually in a two-stage process. The first task is performed by a high-resolution, photo-optical system. This checks each bag and compares the contents with an image database. If parameters such as color, shape, size and quantity match the information in the database, a specialist carries out a visual check in a second step. If anything is unclear, the bag is marked and then checked by hand and corrected if necessary.
Order via the pharmacy
After the photo-optical check, the individual orders per patient are cut and rolled up individually. After the final check, a specialist approves the tubular blister packs for packaging and dispatch. The wholesaler delivers the blisters overnight to the pharmacy that placed the order, which is in contact with the customer. This means that less than 20 hours pass between order placement and delivery! The pharmacy therefore plays a central role in the delivery process. This is because institutions such as retirement and nursing homes that do not have their own home pharmacy cannot order directly from the blister center, but require a consultant pharmacy by law. This pharmacy 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 center. As a rule, a patient’s weekly requirement is blister-packed according to the doctor’s prescription and on behalf of the pharmacy. Package inserts are only available electronically; the contract pharmacy is available to answer any queries.
Cleanroom for hygienic blister packaging
Schweizer Blisterzentrum AG was founded in 2015 as a company of Dr. Bähler Dropa AG. A cleanroom facility was deliberately built for the provision and packaging of medicines in Zurich, making the Swiss Blister Center unique in the country. Production in Switzerland’s most modern blister packaging facility began in March 2016. “We work in a class D Cleanroom. 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 center 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 provides a view of what is happening and allows daylight to stream into the production room. Transparency is very important to the operators of the blister center in every respect: “We are happy to receive visitors who are interested in our service by appointment,” emphasizes Schatzmann, “so they can see our operations for themselves.” The technical cleanroom operation is monitored and secured by a fully integrated control and monitoring system. Particular attention was paid to air exchange and process air extraction due to the dust generated during deblistering and production.
In addition to increased safety, there are also other advantages
“The end product matches the order 100%. This is ensured by multiple checks of the individual machines, between their interfaces and the specialist personnel,” summarizes Schatzmann. It is therefore obvious that the automation of medication dispensing leads to greater safety. However, the use of pre-portioned medication brings further added value for institutions, patients and pharmacies: “For institutions, the focus is on efficiency and time savings thanks to the reduction in the set-up process,” explains Schatzmann. “This frees up nursing staff to focus on their core competencies: care and support.” Ultimately, this benefits the patient. The economic efficiency aspect is also interesting. Schatzmann explains: “The Swiss blister center usually provides the medication as a weekly requirement. Unnecessary stocks of medicines, storage costs and expired products are eliminated. This is an active contribution to reducing healthcare costs.” For patients in retirement and nursing homes, the institution usually covers the costs of packaging. For direct customers of pharmacies, 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 minimized. There is no need to laboriously squeeze tablets out of the pack or cut them in half, and practical individual sachets are ideal for mobile users. Finally, pharmacies also benefit from the service. Blister-packed medicines are a competitive advantage and increase the attractiveness for institutions. Pharmacies that offer the “blister packaging” service gain further expertise 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 with all processes in cleanrooms, only qualified personnel are allowed to work in the cleanroom. “We only employ pharmaceutical specialists with a focus on technical production as well as people with a university degree and diploma,” says Schatzmann. “Regular further training is prescribed and mandatory. The cleaning staff are provided by specialized companies.” The handling of personal patient data also requires a high level of data protection. Like doctors and nurses, staff are subject to the duty of confidentiality and professional secrecy. In accordance with official regulations, the Swiss Blister Center is monitored by Swissmedic. The processes are therefore subject to GMP regulations. Process validations and device qualifications are therefore a matter of course. The Swiss Blister Center makes a major contribution to the cost-effectiveness and safety of modern drug dispensing. The infrastructure in the modern clean rooms also ensures an advanced high standard of hygiene.
Author: Sonja Bichsel-Käser
This article was published: Contamination Control Report 1/2018
