Closed system production of serum eye drops using dockable saline.

BACKGROUND AND OBJECTIVES: A fully closed system solution to manufacture serum eye drops using diluted serum has remained elusive, necessitating production steps to mitigate bacterial contamination risks in a clean suite environment, hampering production efficiency amid growing demand. We describe our recent implementation of a fully closed manufacturing process at New Zealand Blood Service. MATERIALS AND METHODS: A dockable format for sterile saline manufactured to custom specifications configured with a 15-cm tubing to enable sterile connections was sourced from a local pharmaceutical manufacturer. RESULTS: From a total of 30,168 eye drop vials manufactured since implementation, the average production time was reduced by up to 45% performed in the general laboratory environment, attributed to eliminating processes performed in a clean suite. No bacterial contamination was observed, demonstrating robust sterile connections. CONCLUSION: Dockable saline takes serum eye drops manufactured from a functionally closed system to a fully closed system, thereby enhancing patient safety, significantly reducing manufacturing time and cost and transforming production from a highly restrictive process into a portable workflow that is simple, practical and effective.

A comprehensive dosimetric evaluation of using RapidArc volumetric-modulated arc therapy for the treatment of early-stage nasopharyngeal carcinoma.

The purpose of this study was to investigate the potential benefits of using triple-arc volumetric-intensity modulated arc radiotherapy (RapidArc (RA)) for the treatment of early-stage nasopharyngeal carcinoma (NPC). A comprehensive evaluation was performed including plan quality, integral doses, and peripheral doses. Twenty cases of stage I or II NPC were selected for this study. Nine-field sliding window IMRT, double-arc, and triple-arc RA treatment plans were compared with respect to target coverage, dose conformity, critical organ sparing, and integral doses. Measurement of peripheral doses was performed using thermoluminescent dosimeters in an anthropomorphic phantom. While similar conformity and target coverage were achieved by the three types of plans, triple-arc RA produced better sparing of parotid glands and spinal cord than double-arc RA or IMRT. Double-arc RA plans produced slightly inferior parotid sparing and dose homogeneity than the other two delivery methods. The monitor units (MU) required for triple-arc were about 50% less than those of IMRT plans, while there was no significant difference in the required MUs between triple-arc and double-arc RA plans. The peripheral dose in triple-arc RA was found to be 50% less compared to IMRT near abdominal and pelvic region. Triple-arc RA improves both the plan quality and treatment efficiency compared with IMRT for the treatment of early stage NPC. It has become the preferred choice of treatment delivery method for early stage NPC at our center.

Experimental verification of the Acuros XB and AAA dose calculation adjacent to heterogeneous media for IMRT and RapidArc of nasopharygeal carcinoma.

PURPOSE: To compare the doses calculated by the Acuros XB (AXB) algorithm and analytical anisotropic algorithm (AAA) with experimentally measured data adjacent to and within heterogeneous medium using intensity modulated radiation therapy (IMRT) and RapidArc(®) (RA) volumetric arc therapy plans for nasopharygeal carcinoma (NPC). METHODS: Two-dimensional dose distribution immediately adjacent to both air and bone inserts of a rectangular tissue equivalent phantom irradiated using IMRT and RA plans for NPC cases were measured with GafChromic(®) EBT3 films. Doses near and within the nasopharygeal (NP) region of an anthropomorphic phantom containing heterogeneous medium were also measured with thermoluminescent dosimeters (TLD) and EBT3 films. The measured data were then compared with the data calculated by AAA and AXB. For AXB, dose calculations were performed using both dose-to-medium (AXB_Dm) and dose-to-water (AXB_Dw) options. Furthermore, target dose differences between AAA and AXB were analyzed for the corresponding real patients. The comparison of real patient plans was performed by stratifying the targets into components of different densities, including tissue, bone, and air. RESULTS: For the verification of planar dose distribution adjacent to air and bone using the rectangular phantom, the percentages of pixels that passed the gamma analysis with the ± 3%/3mm criteria were 98.7%, 99.5%, and 97.7% on the axial plane for AAA, AXB_Dm, and AXB_Dw, respectively, averaged over all IMRT and RA plans, while they were 97.6%, 98.2%, and 97.7%, respectively, on the coronal plane. For the verification of planar dose distribution within the NP region of the anthropomorphic phantom, the percentages of pixels that passed the gamma analysis with the ± 3%/3mm criteria were 95.1%, 91.3%, and 99.0% for AAA, AXB_Dm, and AXB_Dw, respectively, averaged over all IMRT and RA plans. Within the NP region where air and bone were present, the film measurements represented the dose close to unit density water in a heterogeneous medium, produced the best agreement with the AXB_Dw. For the verification of point doses within the target using TLD in the anthropomorphic phantom, the absolute percentage deviations between the calculated and measured data when averaged over all IMRT and RA plans were 1.8%, 1.7%, and 1.8% for AAA, AXB_Dm and AXB_Dw, respectively. From all the verification results, no significant difference was found between the IMRT and RA plans. The target dose analysis of the real patient plans showed that the discrepancies in mean doses to the PTV component in tissue among the three dose calculation options were within 2%, but up to about 4% in the bone content, with AXB_Dm giving the lowest values and AXB_Dw giving the highest values. CONCLUSIONS: In general, the verification measurements demonstrated that both algorithms produced acceptable accuracy when compared to the measured data. GafChromic(®) film results indicated that AXB produced slightly better accuracy compared to AAA for dose calculation adjacent to and within the heterogeneous media. Users should be aware of the differences in calculated target doses between options AXB_Dm and AXB_Dw, especially in bone, for IMRT and RA in NPC cases.

Principal curves for lumen center extraction and flow channel width estimation in 3-D arterial networks: theory, algorithm, and validation.

We present an energy-minimization-based framework for locating the centerline and estimating the width of tubelike objects from their structural network with a nonparametric model. The nonparametric representation promotes simple modeling of nested branches and n -way furcations, i.e., structures that abound in an arterial network, e.g., a cerebrovascular circulation. Our method is capable of extracting the entire vascular tree from an angiogram in a single execution with a proper initialization. A succinct initial model from the user with arterial network inlets, outlets, and branching points is sufficient for complex vasculature. The novel method is based upon the theory of principal curves. In this paper, theoretical extension to grayscale angiography is discussed, and an algorithm to find an arterial network as principal curves is also described. Quantitative validation on a number of simulated data sets, synthetic volumes of 19 BrainWeb vascular models, and 32 Rotterdam Coronary Artery volumes was conducted. We compared the algorithm to a state-of-the-art method and further tested it on two clinical data sets. Our algorithmic outputs-lumen centers and flow channel widths-are important to various medical and clinical applications, e.g., vasculature segmentation, registration and visualization, virtual angioscopy, and vascular atlas formation and population study.

Learning-based multi-modal rigid image registration by using Bhattacharyya distances.

Multi-modal image registration is a momentous technology in medical image processing and analysis. In order to improve the robustness and accuracy of multi-modal rigid image registration, a novel learning-based dissimilarity function is proposed in this paper. This novel dissimilarity function is based on measuring the dissimilarity between the joint intensity distribution of the testing image pair and the expected intensity distributions, which is learned from a registered image pair, with Bhattacharyya distances. Then, the aim of the registration process is to minimize the dissimilarity function. Eight hundred randomized CT - T1 registrations were performed and evaluated by the Retrospective Image Registration Evaluation (RIRE) project. The experimental results demonstrate that the proposed method can achieve higher robustness and accuracy, as compared with a closely related approach and a state-of-the-art method.