Sterilization Pouches Research Articles

Antibiogram and Bacteriological Assessment of Raw Meat Sold in Owerri, Southeast Nigeria

This study assessed the antibiogram and bacteriological assessment of raw meat sold in Owerri. Samples of fresh beef were taken from beef vendors from three (3) markets; Relief market, Ekeonuwa market and Amakohia market in Owerri, Imo State. Three samples each weighing 100g were aseptically collected in sterile polythene pouches, sealed and transported in ice to the Imo State University Microbiological Laboratory for microbiologic alanalysis within some few hours of collection. The results of this study showed that the total heterotropic bacteria counts of ranged from 3.72× 105cfu/g - 4.2 × 105cfu/g , the coliform bacterial counts ranged from 1.9 × 105cfu/g - 2.7 × 105cfu/g while the total salmonella shigella count ranged from 0cfu/g -4.12x103cfu/g. Bacteria isolated were Escherichia coli, Salmonella spp., Streptococcus spp., Bacillus spp. and Staphylococcus aureus. Of the 50 bacterial isolates obtained, E. coli [15 (27.7)] and Staphylococcus spp [15 (27.7)] were the prevalent isolates. Other bacterial pathogens incriminated in this study were Salmonella spp [9(18.0)], Bacillus spp [7(14.0), and Streptococus spp [4 (8.0)].Most of the Gram-positive bacteria were highly susceptible to ceftizoxime and the Gram-negative to gentamicin and cefotaxime. E. coli, was susceptible to ampicillin/sulbactam (71% susceptibility), cefotaxime (71%), ciprofloxacin (94%), chloramphenicol (94%), ceftizoxime (100%), ofloxacin (82%), and amikacin (100%). S. aureus was susceptible to ampicillin/sulbactam (75%), cephalexin (75%), cefotaxime (100%), roxithromycin (75%), lincomycin (75%), and gentamicin (100%). Bacterial quality of fresh beef sold in Owerri has shown that beef sold in Owerri is contaminated with Staphylococcus spp., Escherichia coli and Salmonella spp. but the prevalence of Salmonella spp. was low.This findings shall guide clinicians in the management of food poisoning/enteritis from possible meat consumption. Effective supervision and health education of meat sellers and their abbatoirs is highly recommended.

The Road to Sustainability in Dentistry – Is the Reuse of Sterilization Pouches Viable?

The Road to Sustainability in Dentistry – Is the Reuse of Sterilization Pouches Viable?

Optimizing Sterilization Packaging through Root Cause Analysis: An Exploration into Sealing Defects of Paper-Plastic Pouches.

BACKGROUND Paper-plastic sterilization pouches are essential in healthcare for preventing instrument contamination. However, sealing defects in these pouches can jeopardize patient safety. To address this issue, our study uses Root Cause Analysis (RCA), aiming to identify contributing factors to these defects and propose practical solutions. Through this, we aim to enhance the overall sterilization process. MATERIAL AND METHODS A retrospective analysis was conducted on 35,762 instruments sterilized and packaged in paper-plastic pouches at our hospital's Central Sterile Supply Department (CSSD) across two periods: July 2020 to June 2021 (pre-RCA, 17,563 instruments) and September 2021 to August 2022 (post-RCA, 18,199 instruments). We evaluated RCA scores, packaging personnel's perceptions of sealing quality, and sealing defect rates before and after RCA implementation. RESULTS Root causes for sealing defects included lack of a standardized inspection procedure, inadequately sized packing table, missed inspections, incorrect distribution procedures, inadequate staff training, and insufficient lighting through the pass-through window between storage and distribution rooms. Among these, lack of a standardized inspection procedure, small packing table size, and missed inspections were statistically significant risk factors (P<0.05). The sealing defect rate decreased from 0.15% pre-RCA implementation to 0.07% post-RCA implementation. CONCLUSIONS Implementing RCA has been shown to effectively enhance the CSSD staff's perception of sealing quality and significantly reduce the incidence of sealing defects in paper-plastic pouches. Thus, RCA serves as an invaluable tool for quality improvement in sterilization packaging processes.

EFFECTS OF WOUND IRRIGATION SOLUTIONS ON HOST TISSUE: MURINE AIR POUCH INFECTION MODEL

Irrigation with antiseptic agents, antibiotics, and surfactants are used for treatment and prevention of infections. Despite desirable microbicidal actions, studies have demonstrated cytotoxic effects on host tissue that may impair healing. This study investigated the extent of tissue damage caused by commonly used irrigation solutions in the presence or absence of infection.Air pouches created in 60 balb/c mice were divided into two groups (n=30): infected with Staphylococcus aureus and control. One week later the infected group was subdivided into 5 subgroups (n=6) based on irrigation solutions and by day 0 (immediately) and day7 after irrigation (n=3). Solutions included Saline, Bacitracin, Clorpactin, Irrisept and Bactisure. In infected group wash fluid was collected for quantitative analysis of bacterial growth. At the specified times mice were sacrificed, pouch tissue sent for histology, and sections analyzed for inflammation, necrosis, and edema.Inflammation decreased in infected vs sterile pouches for all solutions except Bacitracin day 0 and for all solutions day 7 with significance in all except Bacitracin (p&lt;0.05). On day 0, necrosis increased in infected vs sterile pouches in Bacitracin (p=0.006), Irrisept (p=0.18), or Bactisure (p=0.07); however, on day 7, necrosis significantly decreased in infected pouches for all solutions (p&lt;0.05) except for Clorpactin (p=0.18). Edema decreased in infected vs sterile pouches on day 0 for all solutions with significance in saline, Irrisept, and Bacitracin (p&lt;0.05). On day 7, infected pouches had decreased edema in saline, Bacitracin, and Bactisure (p&lt;0.05) and increased in Irrisept (p&lt;0.05) and Clorpactin (p=0.069) compared to sterile pouches. Bacterial culture of washouts demonstrated that Clorpactin, Irrisept and Bactisure controlled the infection, whereas saline and Bacitracin showed bacterial multiplication 3.9 × 10^7 CFU/ml and 6.7 × 10^7 CFU/ml respectively. Bacitracin wash showed significantly more bacteria growth compared to Clorpactin (p=0.024), Irrisept (p=0.025) and Bactisure (p=0.025).Tissue damage varied with irrigation solutions and the presence or absence of infection. Presence of bacteria appeared to lead to less tissue inflammation and edema. Tissue necrosis varied over time with different solutions. Surgeons must weigh risks and benefits when selecting solutions and determining when to irrigate.

Anti-Inflammatory Effect of Dendrobium Huoshanense Polysaccharides on Carrageenan-Induced Air Pouch Synovitis in Mice

Objective: The purpose was to observe the anti-inflammatory effects of Dendrobium huoshanense polysaccharides (DHPs) on carrageenan-induced sterile air pouch synovitis. Materials and Methods: A total of 30 Institute of Cancer Research (ICR) mice were randomly and equally assigned to the control, carrageenan-induced air pouch synovitis model (model), and carrageenan-induced air pouch synovitis model + DHP (200 mg/kg of body weight) (model + DHP) groups. Mice in the model + DHP group were intragastrically administered 200 mg/kg BW of DHP solution daily for 10 days. Mice in the control and model groups were intragastrically administered the same amount of distilled water. Two hours after intragastric administration on day 10, 1 mL of a 1% carrageenan solution in a sterile 0.9% saline solution was injected into the air pouch of mice in the model and model + DHP groups. Six hours later, the mice were sacrificed and 4 mL of ice-cold sterile 0.9% saline solution was injected into the air pouch to fully wash its inner wall. The lavage fluid was collected to observe the color and turbidity of the lavage fluid, as well as the appearance of the backside of the air pouch. The exudate volume, total number of leukocytes, protein content, levels of malondialdehyde (MDA), interleukin-1b (IL-1β), and tumor necrosis factor-alpha (TNF-α), and total superoxide dismutase (T-SOD) activity of the lavage fluid were analyzed. Results: The results showed that pretreatment with DHPs reduced the carrageenan-induced exudate volume (P &lt; 0.01), total leukocytes (P &lt; 0.05), and protein content (P &lt; 0.01) in the air pouch lavage fluid. Furthermore, mice in the model + DHP group had significantly higher (P &lt; 0.01) T-SOD activity and lower MDA content (P &lt; 0.05), IL-1β (P &lt; 0.05), and TNF-α (P &lt; 0.01) levels in the air pouch lavage fluid compared with the model group. Conclusion: It is concluded that DHPs partially alleviated carrageenan-induced sterile inflammation, and its mechanism may be related to reducing exudation and scavenging oxygen-free radicals, inhibiting lipid peroxidation, and reducing the level of the proinflammatory factors, such as IL-1β and TNF-α.

Evaluation of a novel C-Arm draping technique to minimize surgical field contamination and surgery time.

The purpose of this study is to compare the sterility of three C-Arm draping techniques: the clip-drape, sterile pouch, and a novel drape tower method. We hypothesize that our novel technique will minimize floor contamination from reaching the surgical field while allowing the C-Arm machine to rotate between lateral and anterior-posterior positions more quickly. Five trials consisting of rotating the C-Arm and simulating surgeon movement were run using each technique. Ultraviolet light illuminating melamine powder was used to represent floor contamination. Measurements of melamine powder encroachment on the drapes were taken using the top of the C-Arm in lateral position as the reference point. The time needed to assemble, deploy, and retract the C-Arm was measured for each technique. The gown, gloves, and mayo stand were also examined after each trial for contamination. Compared to the clip drape, the drape tower prevented contamination from reaching the C-Arm by an additional 30.5cm (95% confidence interval (CI): 17.0-43.9, P < 0.001). The drape tower had faster deployment and retraction times than both the clip drape (P < 0.001 and P < 0.001, respectively) and sterile pouch (P=0.011 and P < 0.001, respectively). The clip drape and sterile pouch exhibited glove contamination in two (40%) simulations, while the drape tower showed no instances of contamination (P=0.255). The novel drape tower technique limits the encroachment of floor contamination onto sterile drapes. It should be considered as an alternative draping method for lower extremity surgery.

Forced convective heating for low-temperature sterilization.

A novel impermeable sterile pouch is developed to allow the forced convective heating mechanism for improving the sterilization cycle. The heating process is parametrically investigated to obtain an optimized condition in which a sterilization load is heated from 20 to 45 °C within 2min, and the forced convection is experimentally and numerically analyzed to find that the convection coefficient is dramatically increased to 450 W/m2K when compared with the conventional natural convection coefficient of 80 W/m2K. The optimized heating process is applied to a sterilization cycle using the impermeable pouch, and the overall sterilization cycle is found to be completed within 7.5min whose performance is validated by using a process challenge device.

Large-scale screening of rhizobacteria to enhance the chickpea-Mesorhizobium symbiosis using a plant-based strategy

Rhizobacteria able to express multiple plant growth-promoting (PGP) traits has been frequently failed to enhance the chickpea-Mesorhizobium symbiosis possibly because a relatively large amount of organic acids exudated by chickpea root to form an acid rhizosphere reduced the survival and colonisation of plant growth-promoting rhizobacteria (PGPR). Therefore, this study was initiated to screen rhizobacteria that would enhance the chickpea-Mesorhizobium symbiosis using a plant-basedstrategyA total of 743 Bacillus-, Burkholderia- and Pseudomonas-like bacteria were isolated from 74 agricultural soil samples collected across Australia. Only 167 isolates were selected, based upon their individual performance in a seedling growth bioassay, to test their effect on nodulation and growth of chickpea in sterile growth pouches. Also, their ability to produce 1-aminocyclopropane-1-carboxylate (ACC) deaminase and indole acetic acid (IAA) was investigated in relation to their mode of action. The diversity of the 167 isolates was investigated using 16S rDNA sequencing. Of 743 isolates, 697 (83%) were able to produce IAA in the presence of L-tryptophan. ACC deaminase production was detected in 57 isolates (7.7%). Commercial inoculant strain Mesorhizobium ciceri CC1192 produced 7 μg mL−1 IAA and lacked ACC deaminase activity. In further investigation, the promotion of seedling root elongation by rhizobacteria predicted their effect on nodulation and growth of chickpea after dual inoculation in aseptic conditions. The effect of rhizobacteria on seedling root growth as well as shoot growth and nodulation was associated with the capacity of the isolates to produce IAA and ACC deaminase. These isolates were superior in plant growth promotion than those PGPR unable to produce PGP traits. The synthesis of IAA along with ACC deaminase activity by rhizobacteria gave an added advantage in promoting the ability of rhizobia to form an efficient chickpea-Mesorhizobium symbiosis as measured by biomass production and nodulation. Most of these rhizobacteria belonged to the genus Burkholderia. The use of a plant-based first-stage screening strategy in combination with assays for in vitro production of IAA and ACC deaminase enabled the identification of efficient PGPR that were able to enhance the legume-rhizobia symbiosis.

Sterility maintenance of reused disposable paper/plastic sterilization pouches in actual clinical practice

Paper/plastic sterilization pouches are commonly used packaging material for steam sterilization. Reuse of these pouches is a general practice in Thailand despite a single-use recommendation. This study aimed to determine microbial contamination after reusing paper/plastic sterilization pouches in a dental clinic and storage in a closed environment for 6 months. Three hundred and twenty pouches underwent 3 times of clinical use in terms of packaging, autoclave sterilization, handling, and unpacking. A mouth mirror was packed in each pouch to be used in a clinic. After each use, a pouch would be carefully inspected for reusability and undergone packaging, sterilization, handling again. In all steps, sterilization monitoring was rigorously applied. After 3 times of use, a piece of filter paper was placed inside each pouch (instead of a mouth mirror), the pouch was autoclaved and stored in a closed environment for 6 months. Then the filter paper was retrieved for microbial cultivation. A negative control group comprised new pouches containing filter paper without storage and a positive control group comprised pouches with impaired integrity. All samples in both the reuse and the negative control groups had no microbial contamination. All samples in the positive control group showed contamination. These results suggested that reusing paper/plastic sterilization pouches could be a safe practice provided careful monitoring and inspection were employed.

Assessment of microbial contamination of indian currency notes in circulation – An In vitro study

Background: Currency notes represent a universal medium for transmission of bacteria in the environment and among humans. Care should be taken by those handling these currencies. Aim: To quantitatively assess and compare the total bacterial load of Staphylococcus aureus, Escherichia coli, and Proteus species present on the currency notes circulating in the open market area and hospitals in Mangalore city. Methodology: A total of 24 frequently circulated currency notes were collected from open markets and hospitals (12 from each group). They were then deposited in sterile pouches. Samples were collected using moistened cotton swabs and inoculated onto MacConkey agar for bacterial growth. The isolated bacteria were then assessed for the percentage of bacteria and colony-forming units (CFUs) on the notes using standardized microbial analysis. Results: Cultures after microbial analysis showed bacterial contamination with S. aureus, E. coli, Klebsiella, and aerobic spore-bearing bacteria. Approximately >103 CFUs/plate were found. In the hospital group, isolated organisms comprised S. aureus (54%) and E. coli(25%); in the open market areas, E. coli(36%) and S. aureus (38%) were found. Proteus species were not present on any of the samples. Intergroup statistical analysis carried out using the Chi-square test was statistically significant (P = 0.034). Conclusion: The study concluded that the notes from hospitals were contaminated more with S.aureus than in open markets, whereas E. coli was found to be more in open market areas than in hospitals.

Thermal inactivation of Escherichia coli O157:H7 strains and Salmonella spp. in camel meat burgers

The study aimed to determine D and z-values of Escherichia coli O157:H7 strains and Salmonella spp. in camel lean meat burger (CM) and camel meat burger with hump fat (CMF). Two E. coli O157:H7 strains, S. Typhimurium and S. Copenhagen were mixed individually with CM and CMF samples, placed in sterile pouches and exposed to water bath heat treatment at 55, 57.5, 60, 62.5, 65, 67.5 °C for different time intervals. The D-values of E. coli O157:H7 161-84 in CM burgers at 60, 62.5, 65, 67.5 °C were 53.5, 20.1, 8.3, and 3.0 s, respectively, while the values in CMF samples were 76.0, 25.9, 9.9 and 4.1 s, respectively. The D-values of S. Typhimurium in CM burgers at 55, 57.5, 60, 62.5 °C were 349.2, 70.5, 18.4 and 6.7 s, respectively, while the values in CMF were 512.1, 77.1, 21.1 and 8.4 s, respectively. There was a significant (P < 0.05) difference in the D-values of E. coli O157:H7 strains and Salmonella spp. between the two formulations. The z-values of E. coli O157:H7 strains and Salmonella spp. ranged from 5.0 to 6.0 °C and 4.1–4.4 °C, respectively. This study provides preliminary data to the camel meat industry to validate thermal processes.

Assessment of Antibiotic Residues in the Marketed Meat of Kailali and Kavre of Nepal

This is a cross-sectional study to detect presence of antibiotic residues in meat sample of Kailali and Kavre districts. Each sample out of 55 meat samples (muscles and liver) of poultry-41, goat-12, buffalo-9 and pig-4 from Kailali and Kavre was tested for different groups of antibiotic residues separately. The antibiotics tested were Penicillin, Tetracycline, Aminoglycosides, Macrolides and Sulfonamides. Samples were preserved at -84˚C in the deep freezer after collecting in sterile plastic pouch. Rapid test kit (78.9% sensitivity and 96.7% specificity) of G9 Co. Ltd., Thailand was used to detect residues in the samples. The protocol of kit was followed for the test. The overall prevalence of antibiotic residues in meat was around 22%. Meat samples exceeding the Maximum Residue Limit (MRL) were 6. Liver was found with higher number of residues than muscles. The organ and location wise prevalence of residue was found statistically significant at p&lt;0.05. The samples contained alarmingly high level of antibiotic residues which is because of neglecting the withdrawal period. The prescription of antibiotic is not prudent. Int. J. Appl. Sci. Biotechnol. Vol 5(3): 386-389

Hydrothermal Sterilization Improves Initial Osteoblast Responses on Sandpaper-Polished Titanium.

Hydrocarbon contamination accumulated on titanium (Ti) implant surfaces during storage and sterilization is unavoidable and difficult to remove. It impairs the bioactivity of implants, restricts initial interactions between implants and the surrounding biological environment, and has become a common challenge for Ti implants. To overcome this problem, sterilization was considered as the final surface modification and a novel method, hydrothermal sterilization (HS), was proposed. Briefly, stored sandpaper-polished Ti specimens were sterilized in a glass container with pure water at 121 °C for 20 min and kept in the same water until utilization. As a control, another group of specimens was sterilized with conventional autoclaving (AC) at 121 °C for 20 min and stored in sterilization pouches after being dried at 60 °C. Compared with AC, HS deposited numerous nano-sized particles on the substrates, reduced the atomic percentage of the surface carbon, and transformed the Ti surface to a super hydrophilic status. HS also increased the attachment rate, spread, proliferation, and the mineralized nodule areas of rat bone marrow-derived osteoblasts. These results suggest that HS enhances the bioactivity of Ti implants for osteoblasts, and that this biofunctionalization was attributed to nanostructure construction, hydrophilic conversion, and the effective removal of hydrocarbons. Hydrothermal sterilization is proposed to be used as a universal sterilization method for all kinds of titanium implants without apatite coating.

A Comparison of Three C-Arm Draping Techniques to Minimize Contamination of the Surgical Field

The use of intraoperative fluoroscopy has become a routine and useful adjunct within orthopaedic surgery. However, the fluoroscopy machine may become an additional source of contamination in the operating room, particularly when maneuvering from the anterior-posterior position to the lateral position. Consequently, draping techniques were developed to maintain sterility of the operative field and surgeon. Despite a variety of methods, no studies exist to compare the sterility of these techniques specifically when the fluoroscopy machine is in the lateral imaging position. We evaluated the sterility of 3 c-arm draping techniques in a simulated operative environment. The 3 techniques consisted of a traditional 3-quarter sterile sheet attached to the side of the operative table, a modified clip-drape method, and a commercially available sterile pouch. Our study demonstrated that the traditional method poses a high risk for sterile field contamination, whereas the modified clip-drape method and commercially available sterile pouch kept floor contamination furthest from the surgical field. With the current data, we urge surgeons to use modified techniques rather than the traditional draping method.

Liver Exposure Using Sterile Glove Pouch During Laparoscopic Right Liver Surgery in Hepatocellular Carcinoma Patients.

Although laparoscopy is widely accepted for liver resection, lesions in the posterior and superior segments and deep region in the right lobe are difficult for visualization during laparoscopic liver resection (LLR). In this study, we aim examine the effects of using sterile gloves (SG) pouch padding during LLR. Forty-two hepatocellular carcinoma (HCC) patients were included in our study. We performed LLR using SG (n = 24, SG group) and without SG during LLR (n = 18, NSG). We also compared the time of various procedures, blood loss, and liver function between the two groups. We did not observe any major complications or death in all patients. The time of liver parenchyma transection and portal triad clamping in SG group is significantly shorter than those in NSG group (30.29 ± 5.55 vs. 39.00 ± 3.68 min p < .001 for liver parenchyma transection, 23.00 ± 5.60 vs. 31.60 ± 5.03 min p < .001 for portal triad clamping). Blood loss in SG group (162.91 ± 90.91 ml) was significantly lower than in NSG group (236.66 ± 101.67 ml p = .024). The levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were increased one day after LLR, and decreased to normal level on day 7 after LLR in both groups. Our data suggests that a sterile glove pouch could enhance exposure in surgical field, which results in decrease in blood loss and procedure time. More studies with large sample size, large tumor size, and longer follow-up are needed.

Is it safe to reuse dental implant healing abutments sterilized and serviced by dealers of dental implant manufacturers? An in vitro sterility analysis.

This study was undertaken to investigate the sterility of used healing abutments sterilized and serviced by dealers of dental implant manufacturers. Sixty used but sterilized healing abutments in sealed sterilization pouches were obtained from 6 manufacturers unaware of the study design and equally grouped from A to F. The sterilization pouches were examined for perforation. The driver slots and screw grooves of healing abutments were examined for calculus and scratches under a ×5 LED magnifying lamp, without opening the pouches. Each abutment was immersed in brain heart infusion broth in test tubes and incubated. Macroscopic observation of 57 healing abutments revealed dirty screw grooves (10.5%) and partially filled driver slots (5.2%). None of the group C, E, and F samples showed turbidity. Penicillium variabile was morphologically identified in 3 abutments of group A. Enterococcus faecalis and E faecium were detected in 1 abutment each of groups B and D, respectively. Reuse of healing abutments can be cost effective in dental practice. However, used abutments sterilized and serviced by dental implant dealers might be a source of cross-infection. They should therefore be cleaned and resterilized before reuse as a precaution.

Proof of Concept: Containment Systems that Prevent Freeze-Dryer Contamination When Lyophilizing Escherichia coli (JM 109)

This study describes the use of containment systems to prevent escape of microorganisms during lyophilization, thereby avoiding contamination of freeze-drying equipment. Cultures of Escherichia coli (JM 109) of an approximate cell concentration of 109 cfu/mL were suspended in 0.9% saline, aseptically dispensed into vials, double-wrapped in either medical-grade paper or Tyvek sterilization pouches and freeze-dried. An intentional collapse phenomenon was observed during the freeze-drying process, ejecting debris and aerosols from the vials, thus representing a worst-case challenge for containment. Following freeze drying, the layers of the pouches were tested for microbial contamination using 3 M Clean-Trace surface ATP analyzer swabs, surface swabs, and tryptone soya agar contact plates. The paper and Tyvek pouches were able to contain a maximum cell concentration of 1 × 106 cfu/mL of E. coli recovered from ejected debris. Some penetration through the first paper pouch layer was observed (although not Tyvek); however, this was successfully retained by the second, outer layer preventing contamination of the lyophilization apparatus and laboratory environment.

Comprehensive analysis of changes in clinically significant divalent serum cation levels during automated plateletpheresis in healthy donors in a tertiary care center in North India.

Background:Adverse effects due to apheresis are unusual. The most common apheresis-specific reaction is hypocalcemia due to citrate anticoagulation and induces ionized hypocalcemia and hypomagnesemia by chelating effect during the plateletpheresis; generally transient and self-limiting but has the potential of severely injuring donor. We have investigated total calcium (tCa++) and magnesium (tMg++) levels in sixty healthy plateletpheresis donors at different intervals during the procedure and 30 min post-procedure.Materials and Methods:A total of 60 procedures were performed on healthy donors. Blood samples were obtained from sterile diversion pouch placed on apheresis circuit. 5 ml sample in plain vials was obtained at different intervals during each procedure and 30 min after the end of the procedure. Samples were used for measurement of tCa++ and tMg++ levels.Results:There is continuous decrease in mean tCa++ from baseline levels (9.83 ± 0.64 mg/dl) till end of procedure (8.33 ± 0.78 mg/dl), but after 30 min, levels again reached near their respective baseline values (9.42 ± 0.54 mg/dl). Similarly, mean tMg++ fell from baseline levels (2.36 ± 0.3 mg/dl) till the end of procedure (1.39 ± 0.40 mg/dl). After 30 min, levels were again increased, their respective baseline values (2.25 ± 0.25 mg/dl).Conclusion:There is continuous, gradual, and significant fall (P < 0.05) in mean tCa++ and mean tMg++ from baseline levels to till the end of procedure but after 30 min of completion of procedure, levels again reached near their respective baseline values.

A novel approach to sterile pharmaceutical freeze-drying

A novel approach has been developed that enables sterile pharmaceutical products to be freeze-dried in the open laboratory without specialist facilities. The product is filled into vials, semi-stoppered and sealed inside one, followed by a second, sterilization pouch under class 100 conditions. The product is then freeze-dried in the laboratory where the vials are shelf-stoppered before being returned to class 100, unwrapped and crimped. The sterilization pouches increased the resistance to water vapor movement during sublimation, thereby increasing the sublimation time and product temperature. Ovine immunoglobulins were double wrapped and lyophilized (as above) adjusting the primary drying time and shelf temperature for increased product temperature and, therefore, prevention of collapse. Ovine immunoglobulin G formulations freeze-dried to ≤1.1% residual moisture with no effect on protein aggregation or biological activity. The process was simulated with tryptone soya broth and no growth of contaminating microbial cells was observed after incubation at 35 °C for 2 weeks. Although increasing lyophilization time, this approach offers significant plant and validation cost savings when sterile freeze-drying small numbers of vials thereby making the manufacture of treatments for neglected and orphan diseases more viable economically.

Evaluation of extended release brimonidine intravitreal device in normotensive rabbit eyes

To evaluate the safety profile of a brimonidine extended release intravitreal implant, in normotensive rabbit eyes. Devices were made from hollow poly-l-lactic acid (PLA) tubes and contained hundred micrograms of brimonidine pamoate. Device was injected intravitreally in one eye of 12 New Zealand pigmented rabbits, whereas other eye was injected with a sham implant in masked fashion. Ocular examination was conducted at baseline and months 1, 3 and 6 including dilated fundus examination and electro-retinogram (ERG). Four rabbits were sacrificed at each time-point for retinal histology. ERG data were compared between groups and time-points using anova. No complications were reported from either eye of any rabbits over a 6-month period. Photopic A wave was reduced in the control eye at 1 month compared with baseline (p < 0.01). There was no significant difference in other ERG parameters between the groups at different time-points. Gross retinal histology was normal at all time-points. Extended release intravitreal brimonidine device was found to be safe and in normotensive rabbit eyes.