Plastic Ampoules Research Articles

A Review on Blow Fill Seal Machine

Abstract: For medical specialty that area unit administered by sure ways in which like pneumonic delivery, plastic ampoules offers several and points over glass ampoules, vials, or syringes. Plastic ampoules area unit manufacture victimisation blow–fill– seal (BFS) technology. within the BFS method plastic extrusion, molding, antiseptic filling in one line operation. not like tiny molecules, biological drug product, like proteins or being antibodies, area unit a lot of directed to degradation throughout process, which can end in degradation of activity or safety issues. The in operation conditions for a BFS method and therefore the nature of plastic ampoules provides several issues to the steadiness and integrity of biological drug product. during this article, the authors discuss issues within the development and producing of biological product victimisation the BFS method, as well as potential productexposure to elevated temperature, needs for leak detection, and packaging systems. They additionally highlight challenges and techniques for BFS method characterization and validation within the context of biopharmaceutical producing

Comparison of particulate contamination in glass and plastic ampoules of glycyrrhizin injections after ampoule cutting

We evaluated the number and types of particles in glycyrrhizin injections after ampoule cutting. A total of 100 glass ampoules of 5 companies were examined. The mean number of particles with diameter of 1.3- < 5 μm was 252.9/mL, and that of particles with diameter of 5- < 10 μm was 12.5/mL. The number of particles differed among products of the 5 companies, e.g., the number of particles with a diameter of 1.3- < 5 μm varied from 351.9/mL to 121.6/mL. In addition, a total of 120 plastic ampoules from 6 companies were evaluated. The mean number of particles with a diameter of 1.3- < 5 μm was 43.0/mL, and that of particles with a diameter of 5- <10 μm was 2.1/mL. Differences among products of the 6 companies were not significant. The number of particles in glycyrrhizin injections after ampoule cutting was significantly lower in plastic than for glass ampoules (p < 0.0001). Scanning electron microscopy and X-ray microanalysis identified glass fragments in glycyrrhizin injection samples after the cutting of glass ampoules but identified no particles after cutting plastic ampoules. Glycyrrhizin injections are commonly used in Asia including Japan, Taiwan, and China. The use of plastic ampoules is recommended for the prevention of the entry of glass fragments into the body.

New plastic ampoule opening design for use without needles: an evaluation study

Objective To produce a plastic ampoule with an opening that fits syringe adapters to allow solutions to be drawn up without needles (to avoid needle stick and sharps injuries) and to test the effectiveness of the new design in terms of residual fluid volume and risk of microorganism contamination. Methods Evaluation study based on laboratory research was adopted. For the experimental group, 30 ampoules based on the new design were produced by 3D printing. The ampoules were sterilized and filled with 2 ml sterile water. The sterile water was drawn up without the use of needles, and the wastage fluid (i.e., 2 ml minus the quantity drawn up) was calculated. A 1 ml aliquot of sterile water from each ampoule was dropped onto a nutrient agar plate, and the number of colony-forming units was assessed after 48 h. For each ampoule, the experiment was performed twice. Sixty 2 ml glass-packaged sterile water injections constituted the control group. The fluid was drawn up with a needle, and the superfluous fluid and number of colony-forming units were assessed, as in the experimental group. Results The mean wastage fluid was 0.06 ml, 95%CI was 0.05-0.07 ml in the experimental group and the superfluous fluid was 0.06 ml, 95%CI was 0.06-0.07 ml in the control group, there was no significant difference between the two groups (Z=-1.194, P=0.233). The number of colony-forming units was 8 in the experimental group and 4 in the control group, there was no significant difference between the two groups (P=0.224). Conclusions The newly designed plastic ampoule opening could help health workers to avoid needle stick and sharps injuries when drawing up solution. The wastage fluid and microorganism contamination levels met the required standards, indicating that the new design is suitable for clinical application. Key words: Drug packaging; Equipment design; Needle stick injuries; Plastic; Equipment and supplies; Occupational exposure

Https://www.nps.org.au/australian-prescriber/articles/midazolam-for-status-epilepticus

Midazolam is now the first-line treatment for status epilepticus in children. The drug can be given via several different routes. Transmucosal administration is safe, effective, easier to use and more socially acceptable than rectal diazepam. The aim is to stop convulsive seizures that have lasted longer than five minutes as soon as possible. Transmucosal pre-hospital administration by carers is recommended for patients with a predilection for prolonged seizures, or those with limited access to emergency services. This reduces the time to treat and improves outcomes. General practitioners can obtain midazolam through the Prescriber Bag Drug Supplies section of the Pharmaceutical Benefits Scheme. For pre-hospital use, 5 mg in 1 mL plastic ampoules is recommended.

Bacterial contamination of saline used for epidural procedures in an obstetric setting: a randomised comparison of two drawing-up techniques

BackgroundThere is little evidence to inform practice regarding the optimum aseptic technique of drawing up saline for epidural insertion. Our regional practice is to draw up saline from a non-sterile packaged plastic ampoule, therefore introducing the risk of bacterial contamination. Usually, the anaesthetist draws up saline directly from the vial held by an assistant using a needle (needle technique). Alternatively, the saline vial is emptied onto a sterile tray by an assistant and then drawn up by the anaesthetist (tray technique). We hypothesised that the latter will lead to an increase in the number of contaminated saline samples as they are exposed to the environment. MethodsIn labour rooms and before epidural catheter insertion, 110 samples of saline 20mL were randomly drawn up using our hospital’s recommended epidural aseptic precautions, using either the needle or the tray technique. Equal amounts of saline were inoculated into aerobic and anaerobic blood culture bottles. ResultsEleven percent of samples in the needle arm and 24% of samples in the tray arm grew commensal micro-organisms including coagulase-negative Staphylococcus, Micrococcus luteus and Streptococcus viridans. A two-sided Fisher’s exact test for categorical unpaired data showed no statistical difference between the two arms of the trial (P=0.13). ConclusionThe difference in the saline contamination rate between the two techniques did not reach statistical significance. As bacterial contamination occurred with both techniques, we recommend using sterile saline pre-packaged in the epidural tray or individually wrapped sterile glass saline ampoules.

TCH-038 Shortage of Sterile Calcium Gluconate Stock Solution For Parenteral Nutrition: What is the Alternative and How Much Does It Cost?

BackgroundThe Total Parenteral Nutrition (TPN) production facility of our children’s hospital produces around 20,000 units per year with 2 Baxa EM2400 compounders. In June 2012, a shortage of the calcium...

Particulate contamination in plastic ampoules.

Plastic ampoules of Water for Injections, JP, and Injection Sodium Chloride, JP, were investigated to determine their particle load. Four batches were studied. The ampoules were twist-opened as they would be in the clinical setting and the total particle load, both inherent and that created in opening, was determined by reading the contents with a HIAC 420 particle counter with a CMB 60 sensor. The total particle content was found to be minimal, easily complying with world L.V.P. standards and the S.V.P. standard of the USP XXI. The number of particles found in these opened plastic ampoules was significantly lower than that found in clinically snap-opened glass ampoules and also slightly lower than that found in laboratory heat-opened glass ampoules. Whilst the plastic ampoule has a restricted application because it is not suitable for all drugs, it is concluded that when they are used as the immediate container for Water for Injections and Injection Sodium Chloride they are highly effective in reducing the particulate contamination generated in opening.

Speeding Dantrolene Preparation for Treating Malignant Hyperthermia

Dantrolene is known to have a low solubility in water Studies have demonstrated that it dissolves more rapidly in warm water However, the overall benefit of warming has not been measured. This study evaluated the overall time benefit of warming. The first step was to measure how long it took to warm the 10 ml plastic ampoules of sterile water from ambient temperature (20 degrees C) to 45 degrees C. We found that when immersed in a water bath held at 45 degrees C, this required a minimum of seven minutes. Therefore the ampoules used for the study were kept immersed in a water bath held at 45 degrees C for at least 10 minutes. It took an average of 82.6 seconds to draw 60 ml (six ampoules) of water into a 60 ml syringe. Squirting the water into the dantrolene vial and miring until dissolved took 102.8 seconds (SD 8.3) for the warmed water and 129.0 seconds (SD 14.6) for the ambient temperature water (P = 0.009). Redrawing the dantrolene solution into the syringe took an average of 32 seconds for the warmed water and 35.2 seconds for the ambient temperature water. After the redrawing phase the average temperature of the warmed solution was 32.2 degrees C. The average total preparation time for the warmed solution was 217.4 seconds (SD 20.0) and for the ambient temperature preparation was 243.0 seconds (SD 11.7) (P = 0.038). Thus the time difference in preparation was about 256 seconds, which is the time that could be saved in preparing the standard dose of 10 vials of dantrolene using water at 45 degrees C. However, as it required about seven minutes to initially warm the sterile ampoules, there would be a net increase, not decrease in the time required. These findings indicate that warming is of no benefit in speeding dantrolene preparation.

プラスチック製医薬品容器開封時に混入する不溶性微粒子とその沈降挙動

プラスチック製医薬品容器開封時に混入する不溶性微粒子とその沈降挙動

Does wearing CBRN-PPE adversely affect the ability for clinicians to accurately, safely, and speedily draw up drugs?

Objective. Following a Chemical, Biological, Radiation, or Nuclear (CBRN) incident, the attending rescuers will be required to administer drugs while wearing the CBRN Personal Protective Equipment (CBRN-PPE). Little is known regarding the impact of the CBRN-PPE on the ability to speedily, safely, and accurately draw up drugs for subsequent administration. Design. A randomized control trial examining the ability of rescuers to draw up drugs from four different drug presentations (a Minijet prefilled syringe, an Aurum prefilled syringe, and glass and plastic ampoules with needle and syringe) was undertaken with participants wearing and not wearing the National Health Service (NHS) CBRN-PPE. Each participant underwent the procedure once in “normal clothes” and twice while wearing the CBRN-PPE. The speed and accuracy of each participant were measured as well as the participant's perceived risk of suit damage associated with the four different drug presentations. Participants. The participants constituted a non-homogenous group of emergency nurses, nurse lecturers, paramedic lecturers, and student paramedics. A total of 81 participants were recruited; one participant withdrew due to claustrophobia. All participants had used all four drug preparations prior to being enrolled into the study. Results. Wearing the CBRN-PPE had a negative effect on drawing up drugs in the first attempt while wearing the CBRN-PPE, typically taking 63.8% longer time than without (95% confidence interval: 55.3–72.9%). Improvements were noted on second attempts. The choice of drug presentation had an effect on the time taken to draw up the drugs, with Aurum being overall the fastest and glass ampoules the slowest (p-values < 0.001). All participants rated the prefilled syringes as the easiest and the safest to use, and the glass ampoules with needles and syringes as the most difficult to use and the ones most likely to puncture the CBRN-PPE. During the drawing-up process, varying amounts of “drug” were lost, although in two-thirds of the attempts all 10 mL was drawn up. The lowest volume was lost from the prefilled syringes and the maximum volume of fluid was lost from the glass ampoules. Conclusions. The NHS CBRN-PPE has a negative effect on the drawing up of drugs especially from glass ampoules. Glass ampoules represent a poor choice of drug preparation when considering speed, safety, and accuracy of drawing up of drugs while wearing protective clothing.

Preparation of 99mTc radiopharmaceuticals: the effect on radiochemical purity of using sodium chloride injection from plastic ampoules that have been exposed to light

To determine whether radiochemical purity is affected when 99mTc radiopharmaceuticals are prepared using sodium chloride injection from plastic ampoules that have been exposed to light. Sodium chloride injection from plastic ampoules that were either exposed to light for 7 days or protected from light was used in the preparation of nine common 99mTc radiopharmaceuticals: albumin nanocolloid, exametazime, macrosalb, mebrofenin, medronate, pentetate, sestamibi, succimer and tetrofosmin. Five different batches of ampoules (exposed and unexposed) were used for each radiopharmaceutical. Radiochemical purity was measured by established analytical methods (thin-layer chromatography, liquid chromatography and nuclepore filtration) as specified in the European Pharmacopoeia or by the manufacturer. Analysis was performed within 1 h of preparation and at the products' expiries. The radiochemical purity of each 99mTc radiopharmaceutical was satisfactory when unexposed sodium chloride injection was used in its preparation. There was a significant difference between exposed and unexposed results (P < 0.05) for 99mTc exametazime (69.0 ± 9.3% vs. 88.6 ± 0.8%), 99mTc albumin nanocolloid (94.3 ± 1.1% vs. 98.8 ± 0.4%) and 99mTc macrosalb (84.0 ± 4.1% vs. 98.0 ± 2.2%) after preparation. Unsatisfactory radiochemical purity was the result of 99mTc pertechnetate impurity. The radiochemical purities of 99mTc albumin nanocolloid and 99mTc macrosalb increased over time and were satisfactory at their expiries. When 99mTc albumin nanocolloid, 99mTc macrosalb and 99mTc exametazime are prepared using sodium chloride injection from plastic ampoules that have been exposed to light, radiochemical purity is adversely affected. The other 99mTc radiopharmaceuticals tested are unaffected.

A Study on the Insoluble Microparticulate Contamination at Ampoule Opening

The hazardous effects due to the insoluble microparticles generated in the injections have been pointed out. To our knowledge, however, there have been no reports about insoluble microparticulate contamination at ampoule opening. Therefore, we performed this study to evaluate the relationship between time and glass particulate sedimentation to examine the effect of swabbing the ampoule neck on particle generation to clarify the relationship between the inner-diameter size of an ampoule and the amount of glass particulate sedimentation to find out the effect of methods for ampule opening, and compare particle contamination in glass ampoule and that of plastic, after ampoule opening and assessed the contribution of material of ampoule to the particle generation. We observed that the glass particulate contamination of accumulation value at a size over 2 mum increased significantly after 60 seconds, the swabbing the neck of the ampoule prior to opening had a negative effect on prevention of glass particulate contamination, the glass particulate contamination was positively influenced by the inner-diameter size of the ampoule, but not by the thickness of the ampoule walls, the particulate contamination derived from glass significantly increased by general method as well as using ampoule open adaptor compared with our method, and the insoluble microparticulate contamination in plastic ampoule was significantly lower than that in glass ampoule. The present findings might provide an useful information to reduce glass particules after ampoule opening performed in clinical practice.

Preparation of 99 mTc-MAG3: the effect on radiochemical purity of using sodium chloride injection from plastic ampoules that have been exposed to light

To determine the circumstances under which sodium chloride injection (SCI) that has been exposed to fluorescent light then used to prepare 99m Tc-MAG3 causes low radiochemical purity (RCP). Two brands of SCI in plastic ampoules (Braun and Steri-Amp) and one in glass vials (Drytec) were exposed to light for up to 7 days then used to prepare 99m Tc-MAG3. RCP was measured by liquid chromatography. To study the effect on the labelling reaction, the reconstituted MAG3 kit was analysed before and after boiling and the formation of the 99m Tc-tartrate intermediate was investigated. Exposed water from plastic ampoules was analysed by mass spectrometry. After no exposure, each brand resulted in high RCP 99m Tc-MAG3 (>94%). Drytec SCI produced high RCP throughout (96.7 +/- 0.3%, n=5, 7 days). The RCP produced by Steri-Amp and Braun fell to 85.2 +/- 5.2% and 93.5 +/- 1.6% after exposure for 2 and 4 days, respectively. The chromatogram before boiling contained peaks corresponding to 99m Tc-tartrate and 99m Tc-pertechnetate. After boiling with unexposed SCI, these were minimal and a 99m Tc-MAG3 peak dominated. After boiling with exposed SCI, 99m Tc-pertechnetate and 99m Tc-MAG3 peaks were present. Measurements on tartrate showed a high level of 99m Tc-tartrate before and after boiling with unexposed SCI but a high level of 99m Tc-pertechnetate after boiling with exposed SCI. Mass spectrometry showed that compounds leach into the solution upon exposure to light. Preparing 99m Tc-MAG3 using SCI from plastic ampoules that have been exposed to light causes reduced RCP. Exposure of plastic ampoules to light causes leaching of many compounds into the solution. An unknown leached compound destabilizes the 99m Tc-tartrate intermediate complex.

46 The effect of preparing 99mTc-MAG3 using sodium chloride injection from plastic ampoules that have been exposed to light

46 The effect of preparing 99mTc-MAG3 using sodium chloride injection from plastic ampoules that have been exposed to light

Needleless Intravascular Access

Healthcare workers (HCWs) are at risk for needlestick injuries (NSIs), and in the modern context infections acquired in this manner may have lifethreatening sequelae. HCWs often do not report NSIs and this may explain the apathetic attitude that some authorities have adopted, regarding safer “needleless” systems in operating theatres. Completely “needleless” theatre environments can cause a dramatic escalation in costs. However, cheaper options such as drugs in plastic ampoules, blunt drawing-up needles, and three-way stopcocks for administration of drugs, although preventing injury to the HCW, are less effective in preventing contaminated injuries. The combination of the more expensive Engineered Sharps Injury Prevention Devices (ESIPDs)*, Needleless Intermittent Intravenous-access Systems (NIIS) *, and accessible at-hand sharps disposal bins, should also be available, since these decrease the incidence of percutaneous transmission of infection. It is the responsibility of each anaesthetist to insist that these items are always readily available. * ESIPDs : intravenous catheters with introducer needles with built-in safeguarded mechanisms. * NIIS : An example would be needle free fluid administration sets.

Particulate and Microbial Contamination in In-Use Admixed Parenteral Nutrition Solutions

We evaluated particulate and microbial contamination in a total of 192 samples of in-use admixed and unadmixed parenteral nutrition solutions remaining in infusion bags in 10 hospitals. The mean numbers (range) of drug glass ampoules, plastic ampoules, and vials used in a total of 192 admixed solutions were 3.38 (1-13), 0.79 (0-7), and 1.2 (0-8), respectively. The mean number of particles (range) contained in the 192 samples according to the particle size (diameter) was 960.9 (30-9,539)/ml for particles >or=1.3 microm, 42.8 (0-587)/ml for those >or=5 microm, 6.4 (0-146)/ml for those >or=10 microm, and 0.09 (0-1)/ml for those >or=50 microm. The number of particles >or=1.3 microm in diameter was significantly higher in the 192 samples than in 7 samples (controls) of solutions not mixed with any ampoule or vial (p<0.0001). In addition, the number of particles >or=1.3 microm in diameter was significantly higher in samples of solutions mixed with 4-13 glass ampoules than in those of solutions mixed with 1-3 glass ampoules (p<0.01). On the other hand, none of the 199 samples showed bacteria or fungi/5 ml residual solution. Measures against particulate contamination of admixed parenteral nutrition solutions are necessary.

Determination of total mercury in environmental and biological samples using k0-INAA, RNAA and CVAAS/AFS techniques: Advantages and disadvantages

The accuracy and precision of the results obtained for total mercury in various environmental and biological samples and certified reference materials (CRMs) by various analytical methods, including k 0-instrumental neutron activation analysis (k 0-INAA), radiochemical neutron activation analysis (RNAA) and cold vapour atomic absorption (and atomic fluorescence) spectrometry (CVAAS/AFS) used in routine analysis in our laboratory, were investigated. Three natural matrix reference materials (RMs) from the International Atomic Energy Agency (IAEA), five CRMs from the Institute for Reference Materials and Measurements (IRMM), six CRMs from the National Institute of Standards and Technology (NIST) and one from the Jožef Stefan Institute (IJS) were analyzed. The results obtained show good agreement between certified or assigned values, and between the methods used, except for some data obtained by k 0-INAA in biological samples. This can be explained by losses during irradiation in semi-open systems (irradiation in plastic ampoules) and/or spectral interferences.

Accelerated stability studies of morphine injections in plastic ampoules

Although oxygen sensitive, morphine injections are produced in plastic ampoules. In this study, the shelf life of sodium metabisulphite stabilised morphine injections in plastic ampoules was evaluated by accelerated studies at temperatures ranging from 50 to 80°C. A derived model based on the rate equation and the Arrhenius equation was used for extrapolation. Determination of morphine and oxidation products was done by reversed phase ion pair HPLC. The concentration of morphine remained constant during the stability studies. The oxidation of morphine was partly compensated for by diffusion of water through the ampoules. A lag phase was observed for the formation of pseudomorphine. The shelf life is limited to 15 months by diffusion of water through the ampoules.

Use of Clonidine for Chemical Submission

An East-European prostitute in Amsterdam robbed several victims, after having sedated them with clonidine solution (available as plastic ampoules of eyedrops) added to her victims' drinks. One victim was hospitalized. His symptoms included bradycardia, hypotension, hypothermia, pallor, cyanosis, and impaired consciousness. Treatment included isoprenaline for 28 hours. The victim was released from hospital the next day. In court, the female offender confessed and was sentenced to prison for 3 1/2 years. She may have administered doses as high as 8 mg clonidine.

Preparation of 99Tcm-MAG3

Reports have suggested that when sodium chloride injections from a plastic ampoule are used during the preparation of 99Tcm-mercaptoacetyltriglycine (99Tcm-MAG3), the radiochemical purity of the final product might be reduced. A study was therefore undertaken to examine the effect of sodium chloride injections from five manufacturers on the radiochemical purity and stability of 99Tcm-MAG3. One sodium chloride injection was supplied in a glass vial, three in plastic ampoules and one in a plastic infusion bag. Three batches of sodium chloride injections from each manufacturer were tested. The radiopharmaceutical was prepared at a radioactive concentration of 1.1 GBq in 10 ml according to the instructions of the manufacturer of TechneScan MAG3. Analysis of radiochemical purity was performed by high-performance liquid chromatography immediately after preparation and 6 h later. Using 95% as the minimum acceptable radiochemical purity, all the products were satisfactory over the 6 h test period. No manufacturer's sodium chloride injection was found to have a statistically significant effect on the radiochemical purity. Based on the 15 batches of sodium chloride injection tested, this study cannot confirm that sodium chloride injections from a plastic container affect the radiochemical purity of 99Tcm-MAG3. However, in view of the known sensitivity of some 99Tcm radiopharmaceuticals to external influences, it is probably good practice to test radiochemical purity when new batches of ancillary materials, such as sodium chloride injections, are introduced.