Development of a new prototype “Radiopharmacy Media-fill kit”, a new quality control kit to monitor the aseptic production of diagnostic and therapeutic radiopharmaceuticals to be prepared in clinical and hospital isotope laboratories (Q3929709): Difference between revisions
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The present project of RADIOPHARMACY Laboratorio Kft. is part of the objective of the call for proposals in question, since the company is carrying out technological development in the course of its independent R & D & I activities, which will help to create a prototype of a new, commercially usable product with intellectual added value. The objective of this “in-house prototype development” project is to produce a prototype of quality control kits for the aseptic production of radiopharmacy Media-fill kits.The modular prototype allows the performance of all simulation tests used in nuclear medicine tests in a complex way, to provide at the same time the aseptic performance of the preparation environment, the preparation staff, the entire process of preparation, and the possibility of performing the so-called live cell signals (leukocytes, thrombocytes, red blood cells), which are the most specific nuclear medicine tests. Through the research activities planned in this project, the prototype will include tools and materials for modelling and testing the aseptic preparation of parenteral radiopharmaceuticals produced locally for therapeutic and diagnostic purposes in hospital and clinical isotope laboratories. The regular use of the inventory guarantees the practice of correct aseptic preparation in isotope laboratories and will thus ensure adequate microbiological purity of radiopharmaceuticals from laboratories, promote and ensure microbiologically safe patient care in nuclear medicine. In order to achieve the objective of the project, the following activities shall be carried out: The main steps in the production of the kit — work program 1. Preparation of targeted sterile devices, sensitive microbiological mediums and media, sanitation kit: the aseptic preparation kit will contain the sterile devices, sensitive microbiological medium and medium that can be used to model — the preparation of conventional radiopharmaceuticals (isotope generator elution, farm marking, dilution, mixing and distribution) in optimal quantities and composition. — the aseptic production of marked autologous cells used in isotope diagnostics (leukocyte, thromboocyte and erythrocyte separation from and indication of blood), — the aseptic distribution of radiopharmaceuticals used for PET testing, — and to test the basic hygienic state of the environment and the preparation staff during the aseptic procedure. The kit will also contain a basic sanitation kit to clean and disinfect the immediate environment of aseptic preparation before and during work. 2. Implementation of modular applicability: the kit simulating aseptic preparation will include the necessary tools in modules: Module 1 — Sanitation Kit for Disinfection of Critical Surfaces Module 2 — SPECT Radiopharmaceutical Preparation and isotope Generator Control Module 3 — PET Radiopharmaceutical Distribution Module 4 — for cell separation and isotope marking Kit packaging is developed in such a way that the individual modules are available individually and collectively depending on the needs of isotopic laboratories. 3. Compilation of a universal technical description and protocol independent of the manufacturer: each module will include a detailed technical description and protocol to assist in simulation of radiopharmaceutical production independently of the manufacturer. 4. Preparation of the results recorder and evaluation sheet: each module will include a result recording and evaluation sheet in an easily archived form that supports effective official inspection, accreditation of the laboratory 5. Attachment of quality certificate: each module is accompanied by a Quality Certificate demonstrating that the components of the kit are made and of sufficient quality according to GMP specifications. The quality control of kit components is partly carried out in an independent quality control laboratory in the laboratory of RADIOPHARMACY Laboratorio Kft. 6. Production of video tutorials and tutorials: The kit is used by a video in Hungarian and English, which is recorded on a CD. 7. Validation: the prepared kit is used per module in testing radiopharmacy production and then for validation by Radiopharmacy Laboratorio Kft. In the isotope laboratory. For validation, we prepare a validation plan, which will include the method of quality control of the technetium generator, the steps of conventional preparation of one or two commonly used radiopharmaceuticals using the SPECT module, manual distribution of one or two radiopharmaceuticals using the PET module, and the separation and marking of human leukocytes from the Medi-Radioph (English) | |||||||||||||||
| Property / summary: The present project of RADIOPHARMACY Laboratorio Kft. is part of the objective of the call for proposals in question, since the company is carrying out technological development in the course of its independent R & D & I activities, which will help to create a prototype of a new, commercially usable product with intellectual added value. The objective of this “in-house prototype development” project is to produce a prototype of quality control kits for the aseptic production of radiopharmacy Media-fill kits.The modular prototype allows the performance of all simulation tests used in nuclear medicine tests in a complex way, to provide at the same time the aseptic performance of the preparation environment, the preparation staff, the entire process of preparation, and the possibility of performing the so-called live cell signals (leukocytes, thrombocytes, red blood cells), which are the most specific nuclear medicine tests. Through the research activities planned in this project, the prototype will include tools and materials for modelling and testing the aseptic preparation of parenteral radiopharmaceuticals produced locally for therapeutic and diagnostic purposes in hospital and clinical isotope laboratories. The regular use of the inventory guarantees the practice of correct aseptic preparation in isotope laboratories and will thus ensure adequate microbiological purity of radiopharmaceuticals from laboratories, promote and ensure microbiologically safe patient care in nuclear medicine. In order to achieve the objective of the project, the following activities shall be carried out: The main steps in the production of the kit — work program 1. Preparation of targeted sterile devices, sensitive microbiological mediums and media, sanitation kit: the aseptic preparation kit will contain the sterile devices, sensitive microbiological medium and medium that can be used to model — the preparation of conventional radiopharmaceuticals (isotope generator elution, farm marking, dilution, mixing and distribution) in optimal quantities and composition. — the aseptic production of marked autologous cells used in isotope diagnostics (leukocyte, thromboocyte and erythrocyte separation from and indication of blood), — the aseptic distribution of radiopharmaceuticals used for PET testing, — and to test the basic hygienic state of the environment and the preparation staff during the aseptic procedure. The kit will also contain a basic sanitation kit to clean and disinfect the immediate environment of aseptic preparation before and during work. 2. Implementation of modular applicability: the kit simulating aseptic preparation will include the necessary tools in modules: Module 1 — Sanitation Kit for Disinfection of Critical Surfaces Module 2 — SPECT Radiopharmaceutical Preparation and isotope Generator Control Module 3 — PET Radiopharmaceutical Distribution Module 4 — for cell separation and isotope marking Kit packaging is developed in such a way that the individual modules are available individually and collectively depending on the needs of isotopic laboratories. 3. Compilation of a universal technical description and protocol independent of the manufacturer: each module will include a detailed technical description and protocol to assist in simulation of radiopharmaceutical production independently of the manufacturer. 4. Preparation of the results recorder and evaluation sheet: each module will include a result recording and evaluation sheet in an easily archived form that supports effective official inspection, accreditation of the laboratory 5. Attachment of quality certificate: each module is accompanied by a Quality Certificate demonstrating that the components of the kit are made and of sufficient quality according to GMP specifications. The quality control of kit components is partly carried out in an independent quality control laboratory in the laboratory of RADIOPHARMACY Laboratorio Kft. 6. Production of video tutorials and tutorials: The kit is used by a video in Hungarian and English, which is recorded on a CD. 7. Validation: the prepared kit is used per module in testing radiopharmacy production and then for validation by Radiopharmacy Laboratorio Kft. In the isotope laboratory. For validation, we prepare a validation plan, which will include the method of quality control of the technetium generator, the steps of conventional preparation of one or two commonly used radiopharmaceuticals using the SPECT module, manual distribution of one or two radiopharmaceuticals using the PET module, and the separation and marking of human leukocytes from the Medi-Radioph (English) / rank | |||||||||||||||
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| Property / summary: The present project of RADIOPHARMACY Laboratorio Kft. is part of the objective of the call for proposals in question, since the company is carrying out technological development in the course of its independent R & D & I activities, which will help to create a prototype of a new, commercially usable product with intellectual added value. The objective of this “in-house prototype development” project is to produce a prototype of quality control kits for the aseptic production of radiopharmacy Media-fill kits.The modular prototype allows the performance of all simulation tests used in nuclear medicine tests in a complex way, to provide at the same time the aseptic performance of the preparation environment, the preparation staff, the entire process of preparation, and the possibility of performing the so-called live cell signals (leukocytes, thrombocytes, red blood cells), which are the most specific nuclear medicine tests. Through the research activities planned in this project, the prototype will include tools and materials for modelling and testing the aseptic preparation of parenteral radiopharmaceuticals produced locally for therapeutic and diagnostic purposes in hospital and clinical isotope laboratories. The regular use of the inventory guarantees the practice of correct aseptic preparation in isotope laboratories and will thus ensure adequate microbiological purity of radiopharmaceuticals from laboratories, promote and ensure microbiologically safe patient care in nuclear medicine. In order to achieve the objective of the project, the following activities shall be carried out: The main steps in the production of the kit — work program 1. Preparation of targeted sterile devices, sensitive microbiological mediums and media, sanitation kit: the aseptic preparation kit will contain the sterile devices, sensitive microbiological medium and medium that can be used to model — the preparation of conventional radiopharmaceuticals (isotope generator elution, farm marking, dilution, mixing and distribution) in optimal quantities and composition. — the aseptic production of marked autologous cells used in isotope diagnostics (leukocyte, thromboocyte and erythrocyte separation from and indication of blood), — the aseptic distribution of radiopharmaceuticals used for PET testing, — and to test the basic hygienic state of the environment and the preparation staff during the aseptic procedure. The kit will also contain a basic sanitation kit to clean and disinfect the immediate environment of aseptic preparation before and during work. 2. Implementation of modular applicability: the kit simulating aseptic preparation will include the necessary tools in modules: Module 1 — Sanitation Kit for Disinfection of Critical Surfaces Module 2 — SPECT Radiopharmaceutical Preparation and isotope Generator Control Module 3 — PET Radiopharmaceutical Distribution Module 4 — for cell separation and isotope marking Kit packaging is developed in such a way that the individual modules are available individually and collectively depending on the needs of isotopic laboratories. 3. Compilation of a universal technical description and protocol independent of the manufacturer: each module will include a detailed technical description and protocol to assist in simulation of radiopharmaceutical production independently of the manufacturer. 4. Preparation of the results recorder and evaluation sheet: each module will include a result recording and evaluation sheet in an easily archived form that supports effective official inspection, accreditation of the laboratory 5. Attachment of quality certificate: each module is accompanied by a Quality Certificate demonstrating that the components of the kit are made and of sufficient quality according to GMP specifications. The quality control of kit components is partly carried out in an independent quality control laboratory in the laboratory of RADIOPHARMACY Laboratorio Kft. 6. Production of video tutorials and tutorials: The kit is used by a video in Hungarian and English, which is recorded on a CD. 7. Validation: the prepared kit is used per module in testing radiopharmacy production and then for validation by Radiopharmacy Laboratorio Kft. In the isotope laboratory. For validation, we prepare a validation plan, which will include the method of quality control of the technetium generator, the steps of conventional preparation of one or two commonly used radiopharmaceuticals using the SPECT module, manual distribution of one or two radiopharmaceuticals using the PET module, and the separation and marking of human leukocytes from the Medi-Radioph (English) / qualifier | |||||||||||||||
point in time: 8 February 2022
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Revision as of 21:12, 8 February 2022
Project Q3929709 in Hungary
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | Development of a new prototype “Radiopharmacy Media-fill kit”, a new quality control kit to monitor the aseptic production of diagnostic and therapeutic radiopharmaceuticals to be prepared in clinical and hospital isotope laboratories |
Project Q3929709 in Hungary |
Statements
200,487,696 forint
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913,430.497 Euro
0.0027336256 Euro
15 December 2021
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334,146,160.0 forint
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60.0 percent
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1 March 2018
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29 February 2020
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RADIOPHARMACY Laboratórium Kutató- Fejlesztő, Minőségellenőrző, Oktató, Tanácsadó Szolgáltató és Kereskedelmi Korlátolt Felelősségű Társaság
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48°0'21.71"N, 19°47'5.64"E
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A) SZAKMAI TARTALOM A RADIOPHARMACY Laboratórium Kft. jelen projektje illeszkedik szóban forgó pályázati felhívás céljához, hiszen a vállalkozás önálló K+F+I tevékenysége során olyan technológiai fejlesztést hajt végre, melynek segítségével jelentős újdonságoz, szellemi hozzáadott értéket tartalmazó, új, üzletileg hasznosítható termék prototípusa születik meg.Jelen, „házon belüli prototípusfejlesztési” projekt célja, a „Radiopharmacy Media-fill kit” radiofarmakonok aszeptikus előállítását monitorozó minőségellenőrző készlet prototípusának előállítása.A modulszerűen felépülő prototípus komplex módon lehetővé teszi a nukleáris medicina vizsgálatok során alkalmazott valamennyi szimulációs teszt elvégzését úgy, hogy egy időben biztosítja a preparálási környezet, a preparáló személyzet, a preparálás teljes technológiai folyamatának aszeptikus végzését, illetve további lehetőséget biztosít a nukleáris medicina vizsgálatok közül legspeciálisabbnak számító úgynevezett élő sejtjelzések (leukocyta, trombocyta, vörösvértest) végzésére is. Jelen projektben tervezett kutatótevékenység révén a prototípus tartalmazni fogja a kórházi és klinikai izotóplaboratóriumokban terápiás és diagnosztikai célból helyben előállított parenterálisan alkalmazott radiofarmakonok aszeptikus preparálásának modellezéséhez és vizsgálatához szükséges eszközöket és anyagokat. A készlet rendszeres használata garantálja az izotóplaboratóriumokban a helyes aszeptikus preparálás gyakorlatát, és ezáltal biztosítani fogja a laboratóriumokból kikerülő radiofarmakonok megfelelő mikrobiológiai tisztaságát, elősegíti és biztosítja a mikrobiológiai szempontból is biztonságos betegellátást a nukleáris medicina területén. B) MEGVALÓSÍTANDÓ TEVÉKENYSÉGEK A projekt céljának megvalósulás érdekében az alábbi tevékenységek megvalósítása szükséges: A készlet készítésének fő lépései –munka program 1. Célzott steril eszközök, érzékeny mikrobiológiai tápoldatok és táptalajok, szanitáló készlet összeállítása: az aszeptikus gyógyszerkészítést szimuláló kit tartalmazni fogja optimális mennyiségben és összetételben azokat a steril eszközöket, érzékeny mikrobiológiai tápoldatot és táptalajt, amelyek segítségével modellezni lehet - a hagyományos radiofarmakonok preparálását (izotópgenerátor eluálás, farmakon jelzés, hígítás, keverés és szétosztás). - az izotóp diagnosztikában használt jelzett autológ sejtek aszeptikus előállítását (leukocyta, trombocyta és eritrocyta szeparálás vérből és jelzése), - a PET vizsgálatokhoz használt radiofarmakonok aszeptikus szétosztását, - továbbá amelynek segítségével vizsgálható lesz a környezet és preparáló személyzet alapvető higiénes állapota az aszeptikus procedúra során. A kit tartalmazni fog egy alap szanitáló készletet is, amellyel az aszeptikus preparálás közvetlen környezetét a munka megkezdése előtt és közben megtisztíthatjuk és fertőtlenítetjük. 2. Modulszerű alkalmazhatóság megvalósítása: az aszeptikus preparálást szimuláló kit modulokban fogja tartalmazni a szükséges eszközöket: 1.modul - a szanitáló készlet a kritikus felületek fertőtlenítéséhez 2.modul - a SPECT radiofarmakon preparáláshoz és izotópgenerátor ellenőrzéshez 3.modul – a PET radiofarmakon szétosztáshoz 4. modul - a sejtszeparáláshoz és izotópos jelzéshez A kit csomagolása úgy kerül kifejlesztésre, hogy az egyes modulok külön-külön és együttesen is elérhetők legyenek az izotóp laboratóriumok igényeitől függően. 3. Gyártótól független, univerzális technikai leírás és protokoll összeállítása: minden modul tartalmazni fog részletes technikai leírást és protokollt, amely segítséget nyújt gyártótól független módon a radiofarmakon előállítás szimulációjához. 4. Eredményrögzítő és értékelő lap elkészítése: minden modul tartalmazni fog eredmény rögzítő és értékelő lapot könnyen archiválható formában, amely támogatja az eredményes hatósági inspekciót, a laboratórium akkreditációját 5. Minőségi bizonylat csatolása: minden modulhoz Minőségi bizonylat kerül csatolásra, amely bizonyítja, hogy a kit alkotórészei a GMP előírásainak megfelelően készültek és megfelelő minőségűek. A kit összetevőinek minőségellenőrzésére részben független minőségellenőrző laboratóriumban részben a RADIOPHARMACY Laboratórium Kft. laboratóriumában kerül sor. 6. Bemutató és oktató videofilm készítése: A kit használatáról készül egy bemutató és oktató videofilm magyar nyelven és angolul, amelyet CD-n kerül rögzítésre csatolásra. 7. Validálás: az elkészített készlet modulonként kerül felhasználásra radiofarmakon készítés tesztelésében majd pedig validálásra a Radiopharmacy Laboratórium Kft. Izotóplaboratóriumában. A validáláshoz elkészítjük a validálási tervet, amely tartalmazni fogja a technécium generátor minőségellenőrzésének módját, egy vagy két gyakran használt radiofarmakon hagyományos preparálásának lépéseit a SPECT modul segítségével, egy vagy két radiofarmakon kézi szétosztását, adagolását a PET modul felhasználásával, és humán leukociták szeparálását és jelölését a Medi-Radioph (Hungarian)
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The present project of RADIOPHARMACY Laboratorio Kft. is part of the objective of the call for proposals in question, since the company is carrying out technological development in the course of its independent R & D & I activities, which will help to create a prototype of a new, commercially usable product with intellectual added value. The objective of this “in-house prototype development” project is to produce a prototype of quality control kits for the aseptic production of radiopharmacy Media-fill kits.The modular prototype allows the performance of all simulation tests used in nuclear medicine tests in a complex way, to provide at the same time the aseptic performance of the preparation environment, the preparation staff, the entire process of preparation, and the possibility of performing the so-called live cell signals (leukocytes, thrombocytes, red blood cells), which are the most specific nuclear medicine tests. Through the research activities planned in this project, the prototype will include tools and materials for modelling and testing the aseptic preparation of parenteral radiopharmaceuticals produced locally for therapeutic and diagnostic purposes in hospital and clinical isotope laboratories. The regular use of the inventory guarantees the practice of correct aseptic preparation in isotope laboratories and will thus ensure adequate microbiological purity of radiopharmaceuticals from laboratories, promote and ensure microbiologically safe patient care in nuclear medicine. In order to achieve the objective of the project, the following activities shall be carried out: The main steps in the production of the kit — work program 1. Preparation of targeted sterile devices, sensitive microbiological mediums and media, sanitation kit: the aseptic preparation kit will contain the sterile devices, sensitive microbiological medium and medium that can be used to model — the preparation of conventional radiopharmaceuticals (isotope generator elution, farm marking, dilution, mixing and distribution) in optimal quantities and composition. — the aseptic production of marked autologous cells used in isotope diagnostics (leukocyte, thromboocyte and erythrocyte separation from and indication of blood), — the aseptic distribution of radiopharmaceuticals used for PET testing, — and to test the basic hygienic state of the environment and the preparation staff during the aseptic procedure. The kit will also contain a basic sanitation kit to clean and disinfect the immediate environment of aseptic preparation before and during work. 2. Implementation of modular applicability: the kit simulating aseptic preparation will include the necessary tools in modules: Module 1 — Sanitation Kit for Disinfection of Critical Surfaces Module 2 — SPECT Radiopharmaceutical Preparation and isotope Generator Control Module 3 — PET Radiopharmaceutical Distribution Module 4 — for cell separation and isotope marking Kit packaging is developed in such a way that the individual modules are available individually and collectively depending on the needs of isotopic laboratories. 3. Compilation of a universal technical description and protocol independent of the manufacturer: each module will include a detailed technical description and protocol to assist in simulation of radiopharmaceutical production independently of the manufacturer. 4. Preparation of the results recorder and evaluation sheet: each module will include a result recording and evaluation sheet in an easily archived form that supports effective official inspection, accreditation of the laboratory 5. Attachment of quality certificate: each module is accompanied by a Quality Certificate demonstrating that the components of the kit are made and of sufficient quality according to GMP specifications. The quality control of kit components is partly carried out in an independent quality control laboratory in the laboratory of RADIOPHARMACY Laboratorio Kft. 6. Production of video tutorials and tutorials: The kit is used by a video in Hungarian and English, which is recorded on a CD. 7. Validation: the prepared kit is used per module in testing radiopharmacy production and then for validation by Radiopharmacy Laboratorio Kft. In the isotope laboratory. For validation, we prepare a validation plan, which will include the method of quality control of the technetium generator, the steps of conventional preparation of one or two commonly used radiopharmaceuticals using the SPECT module, manual distribution of one or two radiopharmaceuticals using the PET module, and the separation and marking of human leukocytes from the Medi-Radioph (English)
8 February 2022
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Bátonyterenye, Nógrád
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Identifiers
GINOP-2.1.7-15-2016-00744
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