Connecting Across Competencies: Leveraging Best Practices for Processing

The AAMI working group ST/WG 93 is finalizing a standard (AAMI ST98) for the cleaning validation of reusable medical devices based on guidance from the technical information report AAMI TIR30:2011/(R)2016. A number of analytical best practices are being considered for this new standard. Test method suitability for processing cleaning validations historically has been established using one positive control and performing an extraction efficiency. The new cleaning validation standard is proposed to require a change from only one replicate test sample to three when performing method suitability. This change will affect manufacturers; therefore, the value of and consideration for performing these additional replicates requires explanation. This article discusses how variation of validation parameters can affect the accuracy and precision during method suitability testing. Multiple replicates are needed to understand the variability of method extraction and impact on cleaning validations of reusable medical devices.

HPLC Determination of Imidazoles with Variant Anti-Infective Activity in Their Dosage Forms and Human Plasma

A suitable HPLC method has been selected and validated for rapid simultaneous separation and determination of four imidazole anti-infective drugs, secnidazole, omeprazole, albendazole, and fenbendazole, in their final dosage forms, in addition to human plasma within 5 min. The method suitability was derived from the superiority of using the environmentally benign solvent, methanol over acetonitrile as a mobile phase component in respect of safety issues and migration times. Separation of the four anti-infective drugs was performed on a Thermo Scientific® BDS Hypersil C8 column (5 µm, 2.50 × 4.60 mm) using a mobile phase consist of MeOH: 0.025 M KH2PO4 (70:30, v/v) adjusted to pH 3.20 with ortho-phosphoric acid at room temperature. The flow rate was 1.00 mL/min and maximum absorption was measured with UV detector set at 300 nm. Limits of detection were reported to be 0.41, 0.13, 0.18, and 0.15 µg/mL for secnidazole, omeprazole, albendazole, and fenbendazole, respectively, showing a high degree of the method sensitivity. The method of analysis was validated according to Food and Drug Administration (FDA)guidelines for the determination of the drugs, either in their dosage forms with highly precise recoveries, or clinically in human plasma, especially regarding pharmacokinetic and bioequivalence studies.

Microbiological Control of Cellular Products: The Relevance of the Cellular Matrix, Incubation Temperature, and Atmosphere for the Detection Performance of Automated Culture Systems

Background: The microbiological control of cellular products sometimes causes significant procedural issues for quality control laboratories. According to the European Pharmacopoeia (EP), the microbiological control of cellular products requires a 7- to 14-day incubation period at two different incubation temperatures using aerobic and anaerobic growth media. However, the suitability of these test conditions for efficient quality control can be influenced by many conditions, such as the expected microbial spectrum of contamination or the texture and composition of the cellular product. Because of interference, direct inoculation and membrane filtration as reference methods of pharmacopoeia are largely unsuitable for the microbiological control of cellular products; therefore, alternative and, above all, automated methods are the focus of interest. Objective: The aim of our study was to evaluate the method suitability and possible effects of cell matrix, incubation temperature, and oxygen pressure on the detection performance of automated culture systems. Methods: The BacT/ALERT® 3DTM Dual T system (bioMérieux, Nürtingen, Germany) was used to evaluate the factors influencing automated microbiological control of cellular products. The tests were performed using microbial strains recommended by the EP for microbiological method suitability testing and additional relevant possible contaminants of human-derived stem-cell products under varying culture and cell matrix conditions. Results: All contaminants were detected by the system in the required period of 2–5 days. Low incubation temperatures (22°C) had overall negative effects on the detection kinetics of each type of microbial contamination. The adverse effects of the accompanying cell matrix on the detection properties of the system could be compensated in our study by incubation at 32°C in both the aerobic and the anaerobic culture conditions. Conclusion: Automated culture techniques represent a sufficient approach for the microbiological control of cellular products. The negative effects of the cell matrix and microbial contamination on the detection performance can be compensated by the application of variable culture conditions in the automated culture system.

Evaluation of the Volume Measurement Optical Method Suitability for Determining the Relative Compaction of Soils

The goal of this paper is evaluation of the volume measurement optical method suitability for determining relative compaction of soils. The Structure for Motion technique was utilized in order to achieve the goal by making the three-dimensional models (with Bentley ContextCapture software). Created models were used in volume measurement of the pit-holes. The results were compared with the basic methods: the sand cone test and the water method. The laboratory tests were carried out in two stages. In the first stage, the optical method was tested in similar to operating conditions. Ten holes were made in the soil and the volumes were measured with three different methods. The results were compared and submitted for statistical analysis. Statistical analysis showed the potential of optical method. The second laboratory test focused on repeatability and accuracy of measurement. The volume of the vessel imitating a pit-hole was obtained. The results of the second stage showed that the optical method has better accuracy and lower statistical dispersion compared with sand method. On this basis it can be concluded that optical method of volume measurement has great potential in soil compaction testing.

Evaluation of electrochemiluminescence immunoassays for immunosuppressive drugs on the Roche cobas e411 analyzer

Background: Therapeutic drug monitoring of immunosuppressant drugs are used to monitor drug efficacy and toxicity and to prevent organ transplantation rejection. This study evaluates the analytical performance of semi-automated electrochemiluminescence immunoassays (ECLIA) for cyclosporine (CSA), tacrolimus (TAC) and sirolimus (SRL) on the Roche cobas e 411 analyzer at a major transplant hospital to identify method suitability and limitations. Methods: Residual whole blood samples from patients undergoing immunosuppressant therapy were used for evaluation. Experiments included imprecision, linearity, functional sensitivity, method comparisons and lot-to-lot assessments. Results: Total imprecision ranged from 3.3 to 7.1% for CSA, 3.9 to 9.4% for TAC, and 4.6 to 8.2% for SRL. Linearity was verified from 30.0 to 960.9 μg/L for CSA, from 1.1 to 27.1 μg/L for TAC, and from 0.5 to 32.3 µg/L for SRL. The functional sensitivity met the manufacturer’s claims and was determined to be <6.5 μg/L for CSA, 1.1 μg/L for TAC, and <0.1 µg/L for SRL (CV≤20%). Deming regression analysis of method comparisons with the ARCHITECT immunoassay yielded slopes of 0.917 (95%CI: 0.885-0.949) and r of 0.985 for CSA, 0.938 (95%CI: 0.895-0.981) and r of 0.974 for TAC, and 0.842 (0.810-1.110) and r of 0.982 for SRL. Deming regression analysis of comparisons with the LC–MS/MS method yielded slopes of 1.331 (95%CI: 1.167-1.496) and r of 0.969 for CSA, 0.924 (95%CI: 0.843-1.005) and r of 0.984 for TAC, and 0.971 (95%CI: 0.913-1.030) and r of 0.993 for SRL. Conclusions: The cobas e 411 ECLIA for CSA, TAC, and SRL have acceptable precision, linearity, and functional sensitivity. The method comparisons correlated well with the ARCHITECT immunoassay and LC–MS/MS and is fit for therapeutic drug monitoring.

Mechanical properties of commercial rapid prototyping materials

Purpose – This paper aims to relate to the study of mechanical properties of materials used in rapid prototyping (RP). Design/methodology/approach – Comparison of mechanical properties of commercial RP materials. The study of the literature was the essential source of obtaining the results necessary to complete the evaluations and to determine the property ranges. Findings – Specifications of mechanical properties collected in one paper about mechanical properties and anisotropy enable to define limitations for prototype properties. Research limitations/implications – The study is limited to accessible data concerning materials from manufacturers’ offers. Practical implications – The study is particularly useful in the RP methods application. Originality/value – The obtained study of mechanical properties makes a quick analysis possible. This article also includes the guideline for design engineers, which determines RP method suitability to create functional prototypes of the machines. Mechanical properties of materials have been adopted as a criterion.

Study of the Categorisation Method Using Long-term Measurements

Previous studies concerning the categorisation method have been based on short daytime measure- ments. These studies demonstrated urban-noise stratification in the daytime. Nevertheless, legislation and standards refer to noise estimation throughout the day. This paper presents the first attempt to apply the categorisation method to indicators obtained through long-term measurements. The study was conducted in Plasencia, Extremadura (Spain) which has approximately 41,500 inhabitants. First, we conducted a stratification of the roads using the categorisation method. Second, long-term measurements (approxi- mately one week) were conducted at different sampling locations across different categories of streets. The results were analysed by category. Moreover, the profile of the noise-level variation was analysed during the day. The results revealed a stratification of sound levels measured across the different categories. Furthermore, we found health risks due to the noise levels in this town. Short-term measurements were also conducted to complete the categorisation method suitability analysis.