A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis.

An increasing number of pharmaceutical products require deep cold storage at cryogenic conditions, approximately -150°C to -190°C, to maintain stability and/or activity. Previous work has revealed that, at these extreme conditions, a typical pharmaceutical package configuration (vial, stopper, crimp cap) may lose container closure integrity (CCI) due to both the glass transition temperature (-55°C to -70°C) of the rubber stopper used to seal the vial and the different thermal expansion coefficients of the primary packaging components. Importantly, this type of temporary breach in CCI frequently reseals itself when the vial is brought back to ambient temperature.

Comparing Container Closure Integrity Test Methods-Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls.

As described in USP <1207>, the deterministic leak test methods using laser-based gas headspace analysis and helium leakage are those with the highest sensitivities. As stated in the chapter, "no single package leak test or package seal quality test method is applicable to all product-package systems"; therefore, knowing the advantages and disadvantages of both of these techniques, and the extent to which they can be substituted for each other, is valuable. In an effort to begin addressing this issue, a systematic study using these two techniques has been performed.

Container Closure Integrity Test Method Development on Vials Stored at -80°C Using Headspace Carbon Dioxide Analysis.

Maintaining container closure integrity (CCI) is challenging for vials that are packaged at room temperature and stored and/or transported at a colder temperature, such as -80°C. Cold temperatures can affect the sealing mechanisms of the package because of the glass transition temperature (-50°C to -70°C) of the rubber stopper used to seal the vial and the different coefficients of thermal expansion of each of the primary packaging components. Most CCI tests are conducted at room temperature and detect leaks from permanent defects that always exist under all storage conditions.

Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas.

As described in USP <1207>, the container closure integrity (CCI) of a pharmaceutical package must be maintained throughout the product lifecycle to ensure sterility and stability. Current CCI test methods can be time-consuming, destructive, and lack the required sensitivity. This study presents a novel, fast, and nondestructive method for CCI testing that uses carbon dioxide as a tracer gas under effusive pressure conditions.

Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy.

USP <1207.1> Section 3.5 states that "A deterministic leak test method having the ability to detect leaks at the product's maximum allowable leakage limit is preferred when establishing the inherent integrity of a container-closure system.

Classification of playing position in elite junior Australian football using technical skill indicators.

​In team sport, classifying playing position based on a players' expressed skill sets can provide a guide to talent identification by enabling the recognition of performance attributes relative to playing position. Here, elite junior Australian football players were a priori classified into 1 of 4 common playing positions; forward, midfield, defence, and ruck. Three analysis approaches were used to assess the extent to which 12 in-game skill performance indicators could classify playing position.

The relationship between game-based performance indicators and developmental level in junior Australian football: Implications for coaching.

Identifying performance differences between juniors at different stages of a talent pathway may assist with the development of prospective talent. This study investigated the relationship between game-based performance indicators and developmental level in junior Australian football (AF). Players were categorised into 2 groups according to developmental level; U16 and U18.

The use of player physical and technical skill match activity profiles to predict position in the Australian Football League draft.

This study investigated the extent to which position in the Australian Football League (AFL) national draft is associated with individual game performance metrics. Physical/technical skill performance metrics were collated from all participants in the 2014 national under 18 (U18) championships (18 games) drafted into the AFL (n = 65; 17.8 ± 0.

The Application of Noninvasive Headspace Analysis to Media Fill Inspection.

Unlabelled: The results of a proof-of-principle study demonstrating a new analytical technique for detecting microbial growth directly in pharmaceutical containers are described. This analytical technique, laser-based headspace analysis, uses tunable diode laser absorption spectroscopy to nondestructively determine gas concentrations in the headspace of a media-filled pharmaceutical container. For detecting microbial growth, the levels of headspace oxygen and carbon dioxide are measured.

Anthropometric profiling of elite junior and senior Australian football players.

Purpose: Body structure and physical development must be addressed when preparing junior athletes for their first season in a senior competition. The aim of this preliminary study was to measure the extent of the assumption that final year junior Australian Football (AF) athletes are at a physical mismatch to their senior counterparts.

Methods: Twenty-one male participants (17.

Reliability and validity of a reactive agility test for Australian football.

Purpose: The aim of this study was to test the reliability and construct validity of a reactive agility test (RAT), designed for Australian Football (AF).

Methods: Study I tested the reliability of the RAT, with 20 elite junior AF players (17.44 +/- 0.

Hip adductor muscle strength is reduced preceding and during the onset of groin pain in elite junior Australian football players.

Groin pain is a condition with a high prevalence in young Australian football players. It is considered that early identification of this condition allows for optimal management. Eighty-six players from two elite under-age Australian football sides were screened weekly for hip adductor muscle strength, using a hand-held dynamometer and for the onset of groin pain.

The Yo-Yo Intermittent Recovery Test (Level 1) to discriminate elite junior Australian football players.

The Yo-Yo Intermittent Recovery (IR) Test is currently used to assess endurance performance in team sport athletes. However, to date, no data has been presented on its application to an elite junior Australian football (AF) playing group. Therefore, the aim of this study was to evaluate the Yo-Yo Intermittent Recovery Test Level 1 (IR1) ability to discriminate between junior AF players at two different playing standards and a group of non-athletic healthy males.

Profile of position movement demands in elite junior Australian rules footballers.

This study investigated the positional movement patterns in elite junior Australian Football (AF). Thirty players (17.1 ± 0.

Physiological responses of elite junior Australian rules footballers during match-play.

Australian Football (AF) is Australia's major football code. Despite research in other football codes, to date, no data has been published on the physiological responses of AF players during match play. Fifteen athletes (17.

Performance and anthropometric characteristics of prospective elite junior Australian footballers: a case study in one junior team.

The aim of the study was to compare anthropometric and physical performance data of players who were selected for a Victorian elite junior U18 Australian rules football squad. Prior to the selection of the final training squad, 54 players were assessed using a battery of standard anthropometric and physical performance tests. Multivariate analysis (MANOVA) showed significant (p<0.

Player movement patterns in an elite junior Australian rules football team: an exploratory study.

This study explored the physical movement patterns associated with an elite Under 18 Australian Football (AF) team. Five field positions were selected with observations recording the number and relative per cent of "working "efforts (jogging, running, and sprinting), "resting "efforts (walking) and the total distances associated with "working "or "resting "efforts. Intra-observer reliability, using test- retest method, showed correlations were r = 0.

Use of bivalirudin as an anticoagulant during cardiopulmonary bypass.

Bivalirudin is a short-acting direct thrombin inhibitor that has been used in cardiac surgical patients with heparin-induced thrombocytopenia (HIT) or suspected HIT. Although no direct thrombin inhibitor is indicated for anticoagulation during cardiac surgery in patients with heparin-induced thrombocytopenia (HIT) or suspected HIT, use of heparin-alternatives are increasing as the awareness of HIT increases. Reports of anticoagulation with bivalirudin are sporadic, however, with variable dosing and management strategies.

Preemptive use of bivalirudin for urgent on-pump coronary artery bypass grafting in patients with potential heparin-induced thrombocytopenia.

Purpose: The use of heparin in patients with heparin-induced thrombocytopenia (HIT) may result in severe complications or death. The diagnosis of HIT is frequently uncertain, however. Alternative anticoagulants in at-risk patients undergoing cardiac surgery with cardiopulmonary bypass remain problematic.