To wash PIC gel out of the wounds, mice were placed under anaesthesia on a heating mat warmed to 37 °C. First, a droplet of fridge-cooled (~4 °C) sterile saline solution (Braun GmbH, Kronberg, Germany) was added to each wound to attempt reversing the gelation of the gel over a period of roughly one minute. Then, 25 mL of the cold saline was used for flushing and rinsing each wound. This method was performed using a 50 mL syringe (BD Plastipak™, Franklin Lakes, NJ, USA) with (18G Monoject™, Covidien, Tullamore, Ireland) to improve precision and pressure. The imaging study also attempted the method without a cannula but with a 10 mL syringe (BD Plastipak™). Attention was paid to changing the angle and pressure so that each corner of the wound was rinsed out properly. After washing, the cold saline-soaked padding was removed, and the body temperature was recovered with a heating lamp. During this time, new splints were glued in place. Subsequently, the lamp was turned off, and a new dose of PIC gel and the secondary dressing were re-applied.
Plastipak
Manufactured by BD
Sourced in United States, Ireland, Germany, Spain
BD Plastipak is a disposable, sterile syringes and needles product line. It is designed to safely and accurately deliver medications and other fluids. The product features a range of sizes and configurations to meet various clinical needs.
Automatically generated - may contain errors
Lab products found in correlation
Pluronic f68, by Merck Group (3 mentions)
Tween 20, by Merck Group (3 mentions)
Picopump elite, by Harvard Apparatus (3 mentions)
Bca kit, by Thermo Fisher Scientific (3 mentions)
Fitc bsa, by Thermo Fisher Scientific (2 mentions)
Hfe 7500, by Merck Group (2 mentions)
Kds 200, by KD Scientific (1 mentions)
Luer lock syringe, by BD (1 mentions)
Omnifix f, by B. Braun (1 mentions)
Precisionglide needle, by BD (1 mentions)
Combi stopper, by B. Braun (1 mentions)
Universal oven un110, by Memmert (1 mentions)
Sylgard 184, by Dow (1 mentions)
Dneasy powerwater sterivex kit, by Qiagen (1 mentions)
N phenylthiourea, by Merck Group (1 mentions)
Protease inhibitor, by Roche (1 mentions)
Diuron, by Merck Group (1 mentions)
Tygon, by Thermo Fisher Scientific (1 mentions)
Microlance 3, by BD (1 mentions)
Hfe7500 fluorinated oil, by Merck Group (1 mentions)
29 protocols using plastipak
1
Removing PIC Gel from Wound in Mice
2
Microbioreactor Fluid Mixing Experiments
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The microbioreactor fluid system utilized to demonstrate mixing used three (of the five available) inputs and both outputs of the reactor. During mixing experiments, two of the inputs were connected to a single syringe pump (KDS200, KD Scientific, USA), supplying reverse osmosis purified (RO) water, with the third input connected to a separate syringe pump supplying dye. Plastic syringes (5 mL, Plastipak, Becton‐Dickinson, Fisher, USA) were connected to the microbioreactor via FEP tubing (554–2987, VWR International, UK) fluid system. Back‐pressure regulators (P‐790, Upchurch Scientific, USA) were connected to both outputs to prevent bubble formation.
3
Dose Volume Accuracy Validation
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According to Eur.Ph. (monograph 2.9.27), doses of 4 mL were sampled and weighed twenty times. The test was performed using the following devices: 5 mL Luer-lock syringes (Plastipak®, Becton Dickinson, Franklin Lakes, NJ, USA) with an adapter cap (Spruyt hillen, IJsselstein, Netherlands), 5 mL Luer syringes (Injekt®; BBraun, Melsungen, Germany), with an adapter cap (Spruyt hillen, IJsselstein, The Netherlands), and 5 mL syringes for oral use (Nutrifit®; Vygon, Compli, Italy) combined or not with a press-in bottle adapter (Medicina, Bolton, UK). The test was compliant if no more than two of the individual masses deviated from the average mass by more than 10% and none deviated by more than 20%.
4
Holmium Microspheres for Radioembolization
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Holmium-165 acetylacetonate microspheres (165HoAcAcMS) and holmium-165 poly-L-lactic acid microspheres (165HoPLLAMS) were produced by our research group as previously described (31 (link), 32 (link)). 165HoMS were neutron irradiated at the Reactor Institute Delft (Delft University of Technology, Delft, Netherlands) to obtain the predetermined specific radioactivity (MBq/mg 166HoMS) for each patient. The 166HoMS were suspended in sterile water containing 2% poloxamer 188 (Pluronic F-68, Sigma-Aldrich Chemie, Zwijndrecht, Netherlands) by gentle agitation and repeatedly drawing up and down in a syringe. Aliquots of 0.4 ml were drawn up into separate 1 ml Luer-lock syringes (Plastipak, Becton Dickinson, Vianen, Netherlands). Multiple syringes were prepared for each patient, based on tumor volume and consistency. The amount of radioactivity in each syringe was measured in a dose calibrator (VDC-404, Comecer, Joure, Netherlands). To limit exposure of personnel to beta radiation, each syringe was placed into an 8-mm thick acrylic glass cylinder during preparation and treatment.
5
Syringe Residual Volume Evaluation
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We investigated three syringe models (Fig. 1 ): BD Plastipak 1 mL luer slip (Becton Dickinson S.A., Madrid, Spain), Omnifix-F 1 mL (B. Braun Medical Inc., Melsungen, Germany), and Zero Residual Enhanced Dosing Technology (EDT) 0.2 mL (SJJ Solutions BV, Den Haag, Netherlands). Notably, the last model is designed to deliver very small volumes accurately. The BD Plastipak and the Omnifix-F were tested with a standard 30-gauge BD PrecisionGlide needle (Becton Dickinson S.A., Curitiba, Brazil), whereas the Zero Residual EDT was assembled with a 30-gauge Zero Residual needle (SJJ Solutions BV, Den Haag, Netherlands).The syringes tested in the study. ![]()
Left: Omnifix-F from B. Braun Medical Inc. Middle: BD Plastipak from Becton Dickinson S.A. Right: Zero Residual EDT from SJJ Solutions BV.
6
Two-Step Gelation of PI Paste
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Gel production was done similarly to what was described by van Berlo et al.[22] (link). Briefly, after producing a homogenous PI paste, as described in 2.7.1., the paste was transferred to 20 mL syringes (BD Plastipak, Becton Dickinson S.A., Madrid, Spain) and sealed. Thereupon, the paste was subject to a two-step gelation: first, in a 35 °C water batch for 30 min, followed by 20 min in a 90 °C water bath. Immediately after, the syringes were cooled down using ice and were then stored in the fridge (4 °C) overnight to be analyzed the next day.
7
Investigating rFVIIa Reconstitution and Adsorption
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Eptacog alfa (activated) was reconstituted as recommended in the prescribing information
2
with histidine solvent to an rFVIIa concentration of 1.0 mg/mL
1
and transferred to a syringe (BD Plastipak, Becton, Dickinson and Co. Ltd., Ireland). Three batches of rFVIIa were reconstituted to a concentration of 1.0 mg/mL of rFVIIa. The syringe with infusion tube (Original Perfusor Line, Type IV, B. BRAUN Melsungen AG, Germany) and reconstituted rFVIIa was attached to an automated bolus infusion pump (Space Perfusor, Model 8713030, B. BRAUN, Germany). The infusion program was initiated and samples were taken at regular intervals (
Fig. 1 , setups A, B, C). Three different study setups were used; each study setup was run multiple times. Samples were taken from the end of the infusion tube at different time points and were compared with reference samples of rFVIIa. Reference samples of rFVIIa were reconstituted on the day of analysis and stored in the reconstitution vessel. Investigation of product adsorption into the test system was undertaken by comparing degradation of rFVIIa with a reference sample (
Fig. 1 , setup B).
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Eptacog alfa (activated) was reconstituted as recommended in the prescribing information
2
with histidine solvent to an rFVIIa concentration of 1.0 mg/mL
1
and transferred to a syringe (BD Plastipak, Becton, Dickinson and Co. Ltd., Ireland). Three batches of rFVIIa were reconstituted to a concentration of 1.0 mg/mL of rFVIIa. The syringe with infusion tube (Original Perfusor Line, Type IV, B. BRAUN Melsungen AG, Germany) and reconstituted rFVIIa was attached to an automated bolus infusion pump (Space Perfusor, Model 8713030, B. BRAUN, Germany). The infusion program was initiated and samples were taken at regular intervals (
8
Measuring Fluid Flow in Infusion Pumps
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This method consisted in measuring instantaneous delivered fluid flow. We used an automatic flow measurement device: CORI-FLOW™ flow meter (Bronkhorst®, Ruurlo, the Netherlands), which measures instantaneous flow rates (100 measures per second). It also calculates overshoot and possible boluses over the range. We took measurements over 2 h for two Micrel Micropump™ models and the two standard models (Agilia Injectomat® and DPS Orchestra®), with an infusion flow rate set at 5 mL/h, at 300 m and 1700 m, at 22 °C (71.6 °F). A sample of 1200 measurements was extracted during the 2nd h of infusion at steady state.
For both methods, the test bed consisted of a half-filled 50-mL syringe (BD Plastipak, Becton, Dickinson and Company (BD)®, Franckin Lakes, NJ, USA), positioned in the SIP; an infusion line: Injectomat Line (Fresenius Vial S.A.S, Brézins, France) connected to an 18-G catheter at the same height as the syringe’s outlet.
For method A (weight method), catheters were placed directly in the measuring tubes. For method B (automatic flow), the circuit crossed the flow meter.
For both methods, the test bed consisted of a half-filled 50-mL syringe (BD Plastipak, Becton, Dickinson and Company (BD)®, Franckin Lakes, NJ, USA), positioned in the SIP; an infusion line: Injectomat Line (Fresenius Vial S.A.S, Brézins, France) connected to an 18-G catheter at the same height as the syringe’s outlet.
For method A (weight method), catheters were placed directly in the measuring tubes. For method B (automatic flow), the circuit crossed the flow meter.
9
Standardized Subcutaneous Injection Procedure
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All injections were performed with the same model of electric pump. The injection procedure is depicted in Figure 2 . Injections were performed using a delivery system composed of marketed devices. A 50 mL BD Plastipak™ (Becton Dickinson, San Agustin, Spain) syringe was connected to an electric pump (Fresenius Agilia MC; Fresenius Vial, Brezins, France) to enable controlled speed of injection. The Luer Lock Syringe was linked to a 27G needle (Micro-injection needle 0.4×6 mm thin wall Mesalyse®; Puiseux le Hauberger, France) with an extension line (BD Connecta™; Becton Dickinson). To mimic an autoinjector or a bolus injector, the needle was introduced perpendicularly to the skin. A foam pad was used to maintain this position during the entire duration of the injection and to ensure a standardization of the injection depth of 6 mm. The delivery schema is depicted in Figure 2A . In order to avoid bias due to difference of skin sensitivity, the abdomen was divided in six different parts, (Figure 2 ) allocated by randomization for each injection, and the sensitive area around the navel was avoided by keeping at least a distance of 2 cm between the navel and point of injection.
10
Manufacturing of Investigational Cell Therapy
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The final drug product was manufactured as an investigational medicinal product to be tested in various clinical trials (Table 1 ). It was formulated as a ready-to-use suspension, with total cell count and packaging size depending on the intended application. The required quantity of cryopreserved drug substance aliquots, originating from one and the donor skin tissue, were thawed, pooled, washed, and suspended in HRG solution (Ringer’s lactate solution containing 2.5% human serum albumin and 0.4% glucose) at a target concentration of 1 × 107 cells/ml. The cell suspension was filled in one or multiple 1-ml polycarbonate or 10-ml polypropylene syringes (BD Plastipak™, Becton Dickinson, Heidelberg, Germany), as required, which were sealed with polyethylene closing cones (Combi-Stopper, B. Braun, Melsungen, Germany).
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