scholarly journals On-line Preparation of Solutions for Dialysis: Practical Aspects Versus Safety and Regulations

2002 ◽  
Vol 13 (suppl 1) ◽  
pp. S78-S83
Author(s):  
Ingrid Ledebo
Keyword(s):  
Quality Control ◽  
Information Quality ◽  
Cost Effective ◽  
Dialysis Fluid ◽  
Dialysis Therapy ◽  
Retention Capacity ◽  
Continuous Mixing ◽  
Replacement Solution ◽  
On Line ◽  
Routine Quality Control

ABSTRACT. On-line preparation, i.e., continuous mixing and immediate use, was introduced for dialysis fluid in 1964, and it contributed significantly to the expansion of dialysis therapy through simplified handling, improved microbiology, and enhanced efficiency. On-line prepared replacement solution for hemofiltration was shown to be clinically safe as early as 1978, but the implementation was delayed for 20 yr because of regulatory conservatism. On-line preparation of sterile and pyrogen-free solutions for infusion is based on the use of water and concentrates that contribute a minimum of microorganisms and are mixed and distributed in a hygienically designed and maintained flow path. Ultrafilters with known retention capacity are placed in strategic positions and dimensioned to remove bacteria and endotoxins, which gives a sterility assurance level of at least six magnitudes, as required by the Pharmacopoeia for sterile products. Microbiologic testing of the fluid should be applied when designing, validating, and troubleshooting on-line systems but not for routine quality control, because it only gives retrospective information. Quality assurance has to be built into a system and the way it is operated. On-line fluid preparation, when properly performed, is safe, simple, and cost-effective and enhances the efficiency as well as the biocompatibility of dialysis therapy.

scholarly journals Development and validation of UV spectrophotometric method for orbifloxacin assay and dissolution studies

2014 ◽  
Vol 50 (3) ◽  
pp. 457-465 ◽  
Author(s):  
Edith Cristina Laignier Cazedey ◽  
Hérida Regina Nunes Salgado
Keyword(s):  
Quality Control ◽  
Hydrochloric Acid ◽  
Spectrophotometric Method ◽  
Cost Effective ◽  
Pharmaceutical Formulation ◽  
Dissolution Studies ◽  
Linearity Range ◽  
Development And Validation ◽  
Routine Quality Control

New, simple and cost effective UV-spectrophotometric method was developed for the estimation of orbifloxacin in pharmaceutical formulation. Orbifloxacin was estimated at 290 nm in 0.5 M hydrochloric acid. Linearity range was found to be 1.0-6.0 μg mL-1. The method was tested and validated for various parameters according to main guidelines. The proposed method was successfully applied for the determination of orbifloxacin in tablets. The results demonstrated that the procedure is accurate, precise and reproducible, while being simple, economical and less time consuming. It can be suitably applied for the estimation of orbifloxacin in routine quality control and dissolution studies.

scholarly journals Influence of Different Chromatographic Conditions on the Level of Detection and Quantitation of Spironolactone by means of TLC-Densitometry

2019 ◽  
Vol 2019 ◽  
pp. 1-8 ◽  
Author(s):  
Małgorzata Dołowy
Keyword(s):  
Quality Control ◽  
Acetic Acid ◽  
Ethyl Acetate ◽  
Mobile Phase ◽  
Glacial Acetic Acid ◽  
Cost Effective ◽  
Pharmaceutical Formulations ◽  
The One ◽  
Tlc Analysis ◽  
Routine Quality Control

The aim of this study was to estimate the influence of different chromatographic conditions on the limits of detection and limits of quantitation (LODs and LOQs) of spironolactone by means of TLC-densitometry under different chromatographic conditions. A comparison of results obtained showed that the choice of appropriate chromatographic conditions for NP-TLC and RP-TLC analysis with densitometry could effectively decrease the LODs and LOQs of spironolactone. Of all chromatographic systems tested, the best was the one comprising chromatographic plates precoated with a mixture of silica gel 60, kieselguhr F254, and mobile phase A (n-hexane-ethyl acetate-glacial acetic acid, 24.5 : 24.5 : 1, v/v/v). The estimated average LOD and LOQ values were 0.034 and 0.103 μg/spot, respectively. This indicates that the described procedure is sufficiently sensitive for the identification and quantification of spironolactone alone. Thereby, the simple and cost-effective TLC-densitometric method can be utilized for the routine quality control of spironolactone in bulk drugs as well as in simple pharmaceutical formulations.

Monocyte Activation and Humoral Immune Response to Endotoxins in Patients Receiving On-Line Hemodiafiltration Therapy

1998 ◽  
Vol 21 (6) ◽  
pp. 335-340 ◽  
Author(s):  
C. Weber ◽  
H.K. Stummvoll ◽  
S. Passon ◽  
D. Falkenhagen
Keyword(s):  
Microbial Contamination ◽  
Cost Effective ◽  
Dialysis Fluid ◽  
Soluble Cd14 ◽  
Humoral Immune ◽  
On Line ◽  
Continuous Filtration ◽  
Factor Α ◽  
Antibody Levels ◽  
Necrosis Factor

With the on-line preparation of substitution fluid, an easy-to-operate and cost-effective alter-native to conventional hemodiafiltration (HDF) has been realized. The continuous filtration of dialysis fluid, furthermore, allows high volumes of exchange. Microbial contamination and subsequently endotoxins, however, may be present in dialysis fluid, and thus the microbiological safety has become a pivotal issue. In this clinical study we evaluated the safety of the Fresenius Medical Care on-line HDF system which is based on a two-stage filtration of dialysis fluid with upstream DIASAFE® and downstream on-line HDF filter. During the three-month study period we failed to detect germs or endotoxins in the substitution fluid. Augmented plasma interleukin-1β (IL-1β) and tumor necrosis factor α (TNFα) concentrations were found neither during the intradialytic period nor when pre-session values at study begin and study end were compared. In addition, changes in the anti-endotoxin core antibody levels and soluble CD14 (sCD14) concentration, or pyrogenic episodes were not observed. On-line HDF with DIASAFE® and on-line HDF filter thus represents a safe treatment modality by effectively depleting dialysis fluid of cytokine-inducing substances.

UV spectroscopic method for determination of phenytoin in bulk and injection forms

2019 ◽  
Author(s):  
Chem Int
Keyword(s):  
Quality Control ◽  
Spectrophotometric Method ◽  
Spectroscopic Method ◽  
Ich Guidelines ◽  
Precision And Accuracy ◽  
Routine Quality Control

Recent study was conducted to develop a simple UV spectrophotometric method to determine Phenytoin in bulk and injection form according to official requirement and validate as per ICH guidelines. λmax of Phenytoin was found 202 nm. Linearity existed perceived in the concentration assortment 2-8 μg/ml (r2 = 0.999) for the method. The method was validated pertaining to linearity, precision and accuracy studies, LOD and LOQ consistent with ICH guidelines. The existent method was establish to be simple, linear, precise, accurate as well as sensitive and can be applied for routine quality control enquiry for the analysis of Phenytoin in bulk and injection form.

On-Line Quality Control

1995 ◽  
pp. 37-57 ◽  
Author(s):  
Frank W. Henrikson
Keyword(s):  
Quality Control ◽  
On Line

A revised FMEA application to the quality control management

2014 ◽  
Vol 31 (7) ◽  
pp. 788-810 ◽  
Author(s):  
Claudia Paciarotti ◽  
Giovanni Mazzuto ◽  
Davide D’Ettorre
Keyword(s):  
Quality Control ◽  
Failure Modes ◽  
Cost Effective ◽  
Weight Functions ◽  
Time Saving ◽  
Content Type ◽  
Complete Procedure ◽  
Medium Enterprise ◽  
Control Management ◽  
Critical Situations

Purpose – The purpose of this paper is to propose a cost-effective, time-saving and easy-to-use failure modes and effects analysis (FMEA) system applied on the quality control of supplied products. The traditional FMEA has been modified and adapted to fit the quality control features and requirements. The paper introduces a new and revised FMEA approach, where the “failure concept” has been modified with “defect concept.” Design/methodology/approach – The typical FMEA parameters have been modified, and a non-linear scale has been introduced to better evaluate the FMEA parameters. In addition, two weight functions have been introduced in the risk priority number (RPN) calculus in order to consider different critical situations previously ignored and the RPN is assigned to several similar products in order to reduce the problem of complexity. Findings – A complete procedure is provided in order to assist managers in deciding on the critical suppliers, the creation of homogeneous families overcome the complexity of single product code approach, in RPN definition the relative importance of factors is evaluated. Originality/value – This different approach facilitates the quality control managers acting as a structured and “friendly” decision support system: the quality control manager can easily evaluate the critical situations and simulate different scenarios of corrective actions in order to choose the best one. This FMEA technique is a dynamic tool and the performed process is an iterative one. The method has been applied in a small medium enterprise producing hydro massage bathtub, shower, spas and that commercializes bathroom furniture. The firm application has been carried out involving a cross-functional and multidisciplinary team.

Quality Control of Multichannel Hematology Analyzers: Bivariate On-line Comparison of MCV and MCH Values for the Detection of Random Errors

1992 ◽  
Vol 97 (5) ◽  
pp. 645-651
Author(s):  
Veli Kairisto ◽  
Timo Kouri ◽  
Allan Rajamäki ◽  
Arja Virtanen ◽  
Esa Uusipaikka ◽  
...  
Keyword(s):  
Quality Control ◽  
Random Errors ◽  
On Line ◽  
Hematology Analyzers

DEVELOPMENT OF HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF CIPROFLOXACIN AND ORNIDAZOLE IN COMBINED DOSAGE FORM

INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (05) ◽  
pp. 36-43
Author(s):  
N. R Dighade ◽  
◽  
M. D Shende ◽  
A. V Kasture
Keyword(s):  
Quality Control ◽  
High Resolution ◽  
Thin Layer ◽  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Simultaneous Estimation ◽  
Ich Guidelines ◽  
Hptlc Method ◽  
Routine Quality Control

A simple and accurate high performance thin layer chromatographic (HPLTC) method has been developed and validated as per ICH guidelines for estimations of Ciprofloxacin (CP) and Ornidazole (ORN) in combined dosage form. The mobile phase was acetonitrile: toluene: water and triethylamine (5.5:1.8:1.5:1.6 V/V) was found to be best which gave high resolution with Rf 0.16 and 0.84 for ciprofloxacin and ornidazole respectively. The linearity of ciprofloxacin and ornidazole was found to be in the range of 0.4 to 0.8 µg/mL and 0.4 to 0.8 µg/mL, respectively. The coefficient of correlation (r2 ) was found to be greater than 0.989 for both the components by this method. The tablet analyses result (n = 5) were found to be > 100.84 % by HPTLC for both the components. The proposed method was found to be simple, accurate and suitable for routine quality control of marketed formulations containing these drugs.

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