Equipment

This chapter is about the design, quality and application of equipment for the preparation of medicines in a pharmacy or for preparation in small scale pharmaceutical industry. The type of pharmaceutical equipment needed depends on the type of products to be produced, on the required productive capacity and the batch size. A list of essential and critical equipment for production and quality control must be included as attachment in the URS (User Requirements Specification) of any facility. The equipment, requirements, qualification methods, main applications, maintenance and cleaning procedures are described for: • Powder exhaust units, Laminar airflow units, Safety cabinets and Isolators • Pharmaceutical water production • Storage and distribution of pharmaceutical water • Heating and Ultrasonic water baths • Grinding, mixing and dispersing • Filling, dosing and closing for liquids, suppositories, capsules and tubes • Fridges and freezers • Automatic filling and robotics • 3D printing.</p

Equipment

This chapter is about the design, quality and application of equipment for the preparation of medicines in a pharmacy or for preparation in small scale pharmaceutical industry. The type of pharmaceutical equipment needed depends on the type of products to be produced, on the required productive capacity and the batch size. A list of essential and critical equipment for production and quality control must be included as attachment in the URS (User Requirements Specification) of any facility. The equipment, requirements, qualification methods, main applications, maintenance and cleaning procedures are described for: • Powder exhaust units, Laminar airflow units, Safety cabinets and Isolators • Pharmaceutical water production • Storage and distribution of pharmaceutical water • Heating and Ultrasonic water baths • Grinding, mixing and dispersing • Filling, dosing and closing for liquids, suppositories, capsules and tubes • Fridges and freezers • Automatic filling and robotics • 3D printing.</p

Efficacy of Two Cleaning Solutions for the Decontamination of 10 Antineoplastic Agents in the Biosafety Cabinets of a Hospital Pharmacy

Objective: This study aimed to evaluate two cleaning solutions for the chemical decontamination of antineoplastic agents on the surfaces of two biosafety cabinets routinely used for chemotherapy preparation in a hospital pharmacy. Methods: For almost 1 year (49 weeks), two different solutions were used for the weekly cleaning of two biosafety cabinets in a hospital pharmacy's centralized cytotoxic preparation unit. The solutions evaluated were a commercial solution of isopropyl alcohol (IPA) and water (70:30, vol:vol), and a detergent solution constituted by 10-2M of sodium dodecyl sulfate (SDS) with 20% IPA. Seven areas in each biosafety cabinet were wiped 14 times throughout the year, before and after the weekly cleaning process, according to a validated procedure. Samples were analyzed using a validated method of high-performance liquid chromatography coupled to mass spectrometry. The decontamination efficacy of these two solutions was tested for 10 antineoplastic agents: cytarabine, gemcitabine, methotrexate, etoposide phosphate, irinotecan, cyclophosphamide, ifosfamide, doxorubicin, epirubicin, and vincristine. Results: Overall decontamination efficacies observed were 82±6% and 49±11% for SDS solution and IPA, respectively. Higher contamination levels were distributed on areas frequently touched by the pharmacy technicians—such as sleeves and airlock handles—than on scale plates, gravimetric control hardware, and work benches. Detected contaminations of cyclophosphamide, ifosfamide, gemcitabine, and cytarabine were higher than those of the others agents. SDS solution was almost 20% more efficient than IPA on eight of the antineoplastic agents. Conclusion: Both cleaning solutions were able to reduce contamination levels in the biosafety cabinets. The efficacy of the solution containing an anionic detergent agent (SDS) was shown to be generally higher than that of IPA and, after the SDS cleaning procedure, biosafety cabinets demonstrated acceptable contamination level

Evaluation of Decontamination Efficacy of Cleaning Solutions on Stainless Steel and Glass Surfaces Contaminated by 10 Antineoplastic Agents

Objectives: The handling of antineoplastic agents results in chronic surface contamination that must be minimized and eliminated. This study was designed to assess the potential of several chemical solutions to decontaminate two types of work surfaces that were intentionally contaminated with antineoplastic drugs. Methods: A range of solutions with variable physicochemical properties such as their hydrophilic/hydrophobic balance, oxidizing power, desorption, and solubilization were tested: ultrapure water, isopropyl alcohol, acetone, sodium hypochlorite, and surfactants such as dishwashing liquid (DWL), sodium dodecyl sulfate (SDS), Tween 40, and Span 80. These solutions were tested on 10 antineoplastic drugs: cytarabine, gemcitabine, methotrexate, etoposide phosphate, irinotecan, cyclophosphamide, ifosfamide, doxorubicin, epirubicin, and vincristine. To simulate contaminated surfaces, these molecules (200ng) were deliberately spread onto two types of work surfaces: stainless steel and glass. Recovered by wiping with a specific aqueous solvent (acetonitrile/HCOOH; 20/0.1%) and an absorbent wipe (Whatman 903®), the residual contamination was quantified using high-performance liquid chromatography (HPLC) coupled to mass spectrometry. To compare all tested cleaning solutions, a performance value of effectiveness was determined from contamination residues of the 10 drugs. Results: Sodium hypochlorite showed the highest overall effectiveness with 98% contamination removed. Ultrapure water, isopropyl alcohol/water, and acetone were less effective with effectiveness values of 76.8, 80.7, and 40.4%, respectively. Ultrapure water was effective on most hydrophilic molecules (97.1% for cytarabine), while on the other hand, isopropyl alcohol/water (70/30, vol/vol) was effective on the least hydrophilic ones (85.2% for doxorubicin and 87.8% for epirubicin). Acetone had little effect, whatever the type of molecule. Among products containing surfactants, DWL was found effective (91.5%), but its formulation was unknown. Formulations with single surfactant non-ionics (tween 40 and span 80) or anionic (SDS) were also tested. Finally, solutions containing 10-2 M anionic surfactants and 20% isopropyl alcohol had the highest global effectiveness at around 90%. More precisely, their efficacy was the highest (94.8%) for the most hydrophilic compounds such as cytarabine and around 80.0% for anthracyclines. Finally, the addition of isopropyl alcohol to surfactant solutions enhanced their decontamination efficiency on the least hydrophilic molecules. Measured values from the stainless steel surface were similar to those from the glass one. Conclusion: This study demonstrates that all decontamination agents reduce antineoplastic contamination on work surfaces, but none removes it totally. Although very effective, sodium hypochlorite cannot be used routinely on stainless steel surfaces. Solutions containing anionic surfactant such as SDS, with a high efficiency/safety ratio, proved most promising in terms of surface decontaminatio

Equipment

This chapter is about the design, quality and application of equipment for the preparation of medicines in a pharmacy or for preparation in small scale pharmaceutical industry. The type of pharmaceutical equipment needed depends on the type of products to be produced, on the required productive capacity and the batch size. A list of essential and critical equipment for production and quality control must be included as attachment in the URS (User Requirements Specification) of any facility. The equipment, requirements, qualification methods, main applications, maintenance and cleaning procedures are described for: • Powder exhaust units, Laminar airflow units, Safety cabinets and Isolators • Pharmaceutical water production • Storage and distribution of pharmaceutical water • Heating and Ultrasonic water baths • Grinding, mixing and dispersing • Filling, dosing and closing for liquids, suppositories, capsules and tubes • Fridges and freezers • Automatic filling and robotics • 3D printing.</p

Equipment

This chapter is about the design, quality and application of equipment for the preparation of medicines in a pharmacy or for preparation in small scale pharmaceutical industry. The type of pharmaceutical equipment needed depends on the type of products to be produced, on the required productive capacity and the batch size. A list of essential and critical equipment for production and quality control must be included as attachment in the URS (User Requirements Specification) of any facility. The equipment, requirements, qualification methods, main applications, maintenance and cleaning procedures are described for: • Powder exhaust units, Laminar airflow units, Safety cabinets and Isolators • Pharmaceutical water production • Storage and distribution of pharmaceutical water • Heating and Ultrasonic water baths • Grinding, mixing and dispersing • Filling, dosing and closing for liquids, suppositories, capsules and tubes • Fridges and freezers • Automatic filling and robotics • 3D printing.</p

Mise en place d'un système informatisé de préconisation de commandes en pharmacie hospitalière (l'exemple de la P.U.I. de Seclin)

LILLE2-BU Santé-Recherche (593502101) / SudocSudocFranceF

Le soin pharmaceutique (comparaison des systèmes nord-américain et français)

LILLE2-BU Santé-Recherche (593502101) / SudocSudocFranceF

Iléostomies et colostomies (aspects cliniques et pharmaceutiques)

LILLE2-BU Santé-Recherche (593502101) / SudocSudocFranceF

LES GENERIQUES (UN NOUVEL ENJEU POUR LES LABORATOIRES PHARMACEUTIQUES)

LILLE2-BU Santé-Recherche (593502101) / SudocSudocFranceF