Skip to content

INHALATION GENE THERAPY: PROTECTIVE EQUIPMENT IMPLEMENTED

Pdf

PDF Icon

European Statement

Production and Compounding

Author(s)

Scarlett Wise, Pharmacy
Sandrine Gotty, Infectious risk prevention
Sylvain Auvity, Pharmacy
Robert Ratiney, Pharmacy
Caroline Chirk, Pharmacy
Aude Boyer, Clinical investigation center

Why was it done?

Inhalation GTMP’s nature are various, such as mRNA vectorized in lipid nanoparticles and virus GMO therapies. Hospital staff needs reassurance and protective equipment (PE) facing the management of these new ATMPs.

What was done?

Before administrating a new advanced therapy medicinal product (ATMP), including gene therapy medicinal product (GTMP), precaution measures must be implemented for the safety of health care personal at every step of the pharmaceutical process. Administration of GTMP by inhalation generates volatile active substance particles in the air during and after inhalation.
As a result, protection measures were established to secure hospital personal during administration and all through patient hospitalisation.

How was it done?

The dedicated ATMP pharmacist and healthcare manager, identified each key parameter: GTMP nature, persistence on surfaces and types of contamination: airborne, droplet or contact.
The exposition phases in patient’s room were cut down to 3 periods:
1) Administration and instant post administration
2) Hospitalisation post administration
3) Patient discharge
For each period, precautionary measures for entering and exciting patients’ room were discussed:
a. PE
b. Safety distance between personal and patient
c. Bio-cleaning
d. Waste management
Isolation signs for each ATMP were created, approved by the hygiene department and displayed at the entrance of every patient’s room. These signs summarized the good behaviour for every period and detailed the necessary PE.

What has been achieved?

Two isolation signs were created: mRNA and virus-vectorized GTMP.
For 1st period:
Entering: FFP2 mask (airborne), gown, covering glasses, mobcap, gloves and 1.5m distance during administration were identified for both GTMPs. Virus-vectorized GTMP required additional doubled gloves, overshoes and disposable pants.
Room exit: all objects needed decontamination when brought out of patient’s room (contact) for virus-vectorized GTMP.
For 2nd period:
Entering: surgical mask, gown and gloves were identified for both GTMPs. Virus-vectorized GTMP required a surgical mask for the patient (droplets).
For 3rd phase: floor and wall bio-cleaning were necessary and furniture for virus-vectorized GTMP. PE was thrown away in usual waste for mRNA. For virus-vectorized GTMP, PE follows biohazard waste and laundry is identified.
Room exit in all periods required hand washing with hydroalcoholic solution.

What next?

Isolation signs will be created to accompany each new ATMP handling and administration.

OPTIMIZATION OF THE COMPOUNDING AND DISPENSING WORKFLOW FOR VANCOMYCIN-HEPARIN CATHETER LOCK SOLUTIONS: FROM STABILITY DATA TO PRACTICAL IMPLEMENTATION

Pdf

PDF Icon

European Statement

Production and Compounding

Author(s)

D. Samitier; G. Domínguez; JM Montes; P. Ruíz; FJ. García; B. Torroba; C. Jiménez; M. Díaz; M. Guembe; A. Herranz; M. Sanjurjo

Why was it done?

A new standard operating procedure (SOP) was implemented, introducing frozen storage (-20 ºC) to enable large-batch preparation of vancomycin–heparin catheter lock solutions.

What was done?

Vancomycin–heparin lock solution is the most frequently prepared antimicrobial catheter lock in our institution. However, short expiration date limited its efficiency: batches of 16 syringes were prepared and stored under refrigeration (2-8 ºC), with a three-day expiry period, resulting in a high proportion of discarded units.
An in-house physicochemical stability study was carried out. It demonstrated that vancomycin–heparin lock solutions remain stable for up to 12 weeks when frozen and 7 days after thawing, a new preparation and storage protocol was established to optimize workflow, ensure availability and improve sustainability.

How was it done?

The new workflow was implemented in March 2025. Lock solutions (vancomycin 2 mg/mL + heparin 100 IU/mL) were prepared aseptically in 100-syringe batches, stored frozen for up to 3 months, and thawed in sets of 10 for daily use, assigning a 7-day expiry under refrigeration. Implementation required recalculating batch volumes, reorganising storage capacity and performing sterility testing.

What has been achieved?

A six-month comparison period (July–December 2024 vs. April–September 2025) showed that the number of locks prepared decreased from 1024 (64 batches) to 700 (7 batches), while administered locks syringes increased from 605 to 659. Discarded units were reduced from 419 (40.9 %) to 61 (8.7 %). Preparation time per batch increased from 22 minutes (16 locks) to 42 minutes (100 locks), but the overall production time decreased by 79.1 %, waste was reduced by 78.6 %, and the proportion of successfully used locks increased by 35 percentage points. The initiative show to reduce workload, improve product availability, and decrease environmental impact of pharmaceutical waste.

What next?

The frozen-storage strategy has been incorporated in routine practice and is being extended to other antimicrobial lock formulations. This initiative demonstrates how evidence-based stability data can be translated into practical and sustainable improvements in hospital pharmacy operations. The model is transferable to other healthcare settings, particularly those facing limited resources or high discard rates of these preparations.

Development of a compact, disposable filter to reduce the discharge of pharmaceutical waste into the sewer

Pdf

PDF Icon

European Statement

Production and Compounding

Author(s)

Annemarie Aart van der – Beek van der, Mattijs Maris, Erwin Koetse, Alex Hol, Meilof Feiken

Why was it done?

Hospital Pharmacies and especially the laboratories produce wastewater containing medicine residue. When this wastewater is discharged into sewage it contributes to the load of pharmaceutical residue and ultimately to pollution of surface-, ground and drinking water. To reduce this load, waste can be collected and transported to a processing facility for incineration and deactivation or alternatively treated locally. Our goal was to develop a practically applicable method that could effectively reduce the pharmaceutical sewage load locally, at the source.

What was done?

We developed a practical, compact, disposable filtration system that can be used on-site to reduce the amount of pharmaceutical residue in wastewater of our pharmaceutical laboratory. We tested and optimized the composition of the filter to effectively collect organic substances from locally produced wastewater (influent). We monitored filter performance and durability by analysis of filtrates (effluent).

How was it done?

Laboratory wastewater was collected during one month to yield 10 L influent. Portions of influent were filtered through 9 different types of filter packing and the effluents collected for analysis.
The influent reference and effluent samples were analysed using an iontrap LC/MS screening method using diazepam-D5 as an internal standard. The signal abundance 12 most relevant substances was chosen to evaluate the level of reduction by filtration. Based on these analyses, the optimal filter packing was determined.

What has been achieved?

In the effluent of the best performing filter packing, the abundance of 9 substances was reduced by 91,5-99,9%. The abundance for the other 3 substances was below detection limit.
Substances removed more >99%: atorvastatine, carbamazepine, clarithromycine, diclofenac, granisetron, midazolam, naproxen, propranolol and rocuronium. Substances removed between 91-99%: cefazolin, ephedrine and ropivacaine.

What next?

The optimal filter composition will be tested in practice in a test setup. In addition, cost effectiveness and sustainability compared to alternative waste collection methods will be evaluated.

COMPARISON OF ENVIRONMENTAL CONTAMINATION WITH CYTOSTATICS IN FOUR AUSTRIAN HOSPITALS AND IMPLEMENTATION OF A STANDARDISED TRAINING ABOUT SAFE HANDLING OF ANTINEOPLASTIC AGENTS ON THE WARD

Pdf

PDF Icon

European Statement

Production and Compounding

Author(s)

Martin Munz, Ewelina Korczowska, Maria Costa, Christine Petter, Shahla Farokhnia, Katharina Kronister, Sandra Dunkler, Thomas Schweiger, Martina Anditsch, Martina Jeske

Why was it done?

Several studies show that contamination with cytostatics is found on various work surfaces in hospitals [e.g., Chauchat L et al. 2018, Hon CY et al. 2014]. Wipe sampling for surface residue of antineoplastic and other hazardous drugs in healthcare settings is currently the method of choice to determine the workplace’s environmental contamination with these drugs [Connor TH et al. 2016].

What was done?

Hospital pharmacists of four Austrian hospitals (Vienna General Hospital, Innsbruck University Hospital, Landesklinikum Horn-Allentsteig, and Landesklinikum Zwettl) differing in size, logistic requirements and production capacity, equipment (but all using Closed System Devices), and involved staff participated in the MASHA (Research about Environmental Contamination by Cytotoxics And Management of Safe Handling Procedures) project of the European Society of Oncology Pharmacy (ESOP).

How was it done?

In the first part of the project, surface contamination by cytostatics was investigated using wipe samples. Subsequently, training materials were developed and used for uniform training of medical staff involved in administering antineoplastic drugs. After the training, a second set of wipe samples of the same surfaces were taken and analyzed.

What has been achieved?

All four hospitals’ results in the first series of measurements were below the reference value given in the project of 0,1ng/cm², indicating “low” contamination. Only a small amount of samples show values between the limit of quantification (LOQ), dependent on the substance and analytical method, and 0,1ng/cm². The same is for the second series of wipe samples after the training. Considering that standards, recommendations or trainings by pharmacists or occupational health professionals has already been in place before this project, the impact of further training for the medical staff could not be quantified by measuring the residues. However, feedback from trained staff was exclusively positive, and our main objective to demonstrate that occupational exposure with cytostatics is low to non-detectable on our wards was achieved.

What next?

We want to encourage more hospitals to get involved in similar projects, and we hope that more powerful analytics will give us more answers for proper handling.