Who is responsible for intravenous drug preparation in hospitals?
Considering EU norms in this matter pharmacists are fully responsible for it. Due to inadequacy of current law and regulatory statutes in the country, these types of works are done by diverse healthcare professionals. While these types of drugs are prepared, instructions such as USP should be carefully followed, and the possibility of contamination that can be resulted from the smallest negligence, should be avoided.
What is a Cleanroom?
According of the definition by International Standards Organizations (ISO), a Cleanroom is the room “where the particle density in its air can be controlled, and the parameters such as humidity, temperature and pressure can be adjusted, if necessary; and also which includes design elements that can minimize enter of particles into the room, together with presence and growth of them in the room”.
Why do you prefer the installation of Cleanrooms?
TPN and Antineoplastic Drug Preparation units we focused are primarily the magistral drug preparation systems, and should be produced in accordance with GMP standards as per the related regulatory statutes since they are preparates for intravenous administration. For that purpose, production is carried out in an area free from particles, and a level of national standards of ISO Class 5 (ISO 100) is desired. This value corresponds to 100 particles at 1 cubic foot of air.
What are the objective and outcomes of SafeChemo Project (Safe Chemotherapy Project)?
It is a project completed with the evaluation of CytoCare® and software used for about 2 years at 3 hospitals in London, Bolzano and Copenhagen, and issued by European Union Commission. The primary purpose of this project is to prepare hazardous IV drug compounding, which is efficient and reliable with measurable values, in addition to ensure the safety of patients and the staff. As a result of 17 scientific studies conducted in 3 hospital pharmacies, CytoCare® is found to ensure the safety of the staff against toxic agents, aseptic filling guarantee, elimination of cross contamination risk and savings for drugs. In the wake of researches made, drugs prepared with CytoCare®, are found to be one million times safer than manual drug compounding.
What do we know about the frequently raised issue of USP<797> in preparation of sterile products?
USP<797> is a guide prepared by United States Pharmacopoeia (USP) for preparation of sterile drugs in compounder devices. USP is a set of instructions to be used in a wide range areas including drug preparation conditions, cleanroom conditions, definition, trainings, evaluations of the staff responsible for drug preparation, cleanroom rules, disinfection, procedures; microbiological and engineering evaluations of cleanrooms; risk levels in sterile drug preparation; product labels; and drug systems.
What are the properties of HEPA filters used in Cleanrooms?
It is a dry-type filter placed within a rigid frame, at an efficiency of 99.97% (maximum penetration 0.03%), holding particles in size of 0.3µm. (HEPA Filter – High Efficiency Particulate Air Filter). Within a working area with this type of filtration, air quality values determined with instructions is ensured.
In which conditions (oncologic or TPN) IV drug compounding prepared is not used?
If particles can be observed within the solution; if crystal formation is in question; if colour change and turbidity occurred; if bubble formation exists or stratification is observed within the compounding; if expected expiration date of the compounding is exceeded or existing doubts show that it is kept under appropriate storage conditions, it is the best way to avoid using the solutions with these features.