Respiratory solutions

Blow-Fill-Seal (BFS) technology was developed in the early 1960s and was initially used for filling many liquid product categories, for example, nonsterile medical devices, foods, and cosmetics. The technology has been developed to an extent that today BFS systems are used to aseptically produce sterile pharmaceutical products such as respiratory solutions, ophthahnics, and wound-care products throughout the world. 

Fig. 2 Schematic diagram of a typical ultrasonic nebulizer. (A) Face mask or mouthpiece (B) baffles (C) geyser of respiratory solution or suspension (D) piezoelectric crystal (E) internal fan (F) battery or electrical source. (From Ref. l)...

Currently, there are no U.S. Pharmacopeia or European Pharmacopoeia standard tests for characterizing the output of respiratory solutions or suspensions generated by air-jet or ultrasonic nebulizers. 

Respiratory solute absorption Epithelial permeability <2 xm Interstitial lung disease, lung injury, Pneumocystis carinii pneumonia, adult respiratory distress syndrome... 

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Mild exposure to HF via inhalation can irritate the nose, throat, and respiratory system. The onset of symptoms may be delayed for several hours. Severe exposure via inhalation can cause nose and throat bums, lung inflammation, and pulmonary edema, and can also result in other systemic effects including hypocalcemia (depletion of body calcium levels), which if not promptly treated can be fatal. Permissible air concentrations are (42) OSHA PEL, 3 ppm (2.0 mg/m ) as E OSHA STEL, 6 ppm (5.2 mg/m ) as E and ACGIH TLV, 3 ppm (2.6 mg/m ) as E. Ingestion can cause severe mouth, throat, and stomach bums, and maybe fatal. Hypocalcemia is possible even if exposure consists of small amounts or dilute solutions of HE. 

Propylene oxide is a primary irritant, a mild protoplasmic poison, and a mild depressant of the central nervous system. Skin contact, even in dilute solution (1%), may cause irritation to the eyes, respiratory tract, and lungs. Propylene oxide is a suspected carcinogen in animals. The LC q (lowest lethal concentration by inhalation in tats) is 4000 mg/kg body weight. The LD q (oral) is 930 mg/kg. The LD q (dermal) is 1500 mg/kg. The TWA (8-h exposure) is 100 ppm and the STEP (15-min exposure) is 150 ppm. 

Methohexital [18652-93-2] (Brevital), C 4H gN202, (2) is a barbiturate iv anesthetic iaduction agent that has a slightly faster onset than thiopentone and less accumulation. The recovery from anesthesia is also slightly faster and better. However, iaduction is associated with an iacreased iacidence of excitatory phenomena. Methohexital also causes respiratory and cardiovascular depression and is unstable ia solution, necessitating reconstitution before use (99). 

Manufacture, Shipment, and Analysis. In the United States, sodium and potassium thiocyanates are made by adding caustic soda or potash to ammonium thiocyanate, followed by evaporation of the ammonia and water. The products are sold either as 50—55 wt % aqueous solutions, in the case of sodium thiocyanate, or as the crystalline soHds with one grade containing 5 wt % water and a higher assay grade containing a maximum of 2 wt % water. In Europe, the thiocyanates may be made by direct sulfurization of the corresponding cyanide. The acute LD q (rat, oral) of sodium thiocyanate is 764 mg/kg, accompanied by convulsions and respiratory failure LD q (mouse, oral) is 362 mg/kg. The lowest pubhshed toxic dose for potassium thiocyanate is 80—428 mg/kg, with hallucinations, convulsions, or muscular weakness. The acute LD q (rat, oral) for potassium thiocyanate is 854 mg/kg, with convulsions and respiratory failure. 

Detection of Bromine Vapor. Bromine vapor in air can be monitored by using an oxidant monitor instmment that sounds an alarm when a certain level is reached. An oxidant monitor operates on an amperometric principle. The bromine oxidizes potassium iodide in solution, producing an electrical output by depolarizing one sensor electrode. Detector tubes, usefiil for determining the level of respiratory protection required, contain (9-toluidine that produces a yellow-orange stain when reacted with bromine. These tubes and sample pumps are available through safety supply companies (54). The usefiil concentration range is 0.2—30 ppm. 

The threshold limit value—time integrated average, TLV—TWA, of chlorine dioxide is 0.1 ppm, and the threshold limit value—short-term exposure limit, STEL, is 0.3 ppm or 0.9 mg /m of air concentration (87,88). Chlorine dioxide is a severe respiratory and eye irritant. Symptoms of exposure by inhalation include eye and throat irritation, headache, nausea, nasal discharge, coughing, wheezing, bronchitis, and delayed onset of pulmonary edema. Delayed deaths occurred in animals after exposure to 150—200 ppm for less than one hour. Rats repeatedly exposed to 10 ppm died after 10 to 13 days of exposure. Exposure of a worker to 19 ppm for an unspecified time was fatal. The ingested systemic effects of low concentration chlorine dioxide solutions are similar to that of chlorite. 

Formaldehyde gas (Oxymethylene) HCHO 430 7.0-73.0 1.1 -21 Colourless Water soluble gas producing formalin solutions Suffocating odour Polymerizes readily Highly toxic Respiratory sensitizer... 

Formaldehyde has been rated as a possible carcinogen by the United States Occupational Safety and Health Act (OSHA) rules and should be handled with due caution. It is also a strong lacrymator and choking respiratory irritant. It irritates the skin, eyes, and mucous membranes [76]. Since it is used for tanning leather, it is obvious that fonnaldehyde has a high potential for reactions with proteins. Formaldehyde gas is flammable and most formalin solutions contain significant amounts of methanol, which is also volatile, toxic, and flammable. 

Examine health reeords in your plant. Organize these by work areas and assess whether there are statistically higher ineidents that support respiratory ailments, including cold and flu statistics. If the data supports a particular work area as having a problem, can you identify the reasons If so, what are they and how would you go about better defining the problem and a solution ... 

Fire Hazards - Flash Point (deg. F) 20 CC Flammable Limits in Air (%) 2.8 - 14.4 Fire Extinguishing Agents Stop flow of gas. Use water spray, carbon dioxide, or dry chemical for fires in water solutions Fire Extinguishing Agents Not to be Used Do not use foam Special Hazards of Combustion Products Vapors are eye, skin and respiratory irritants Behavior in Fire Not pertinent Ignition Temperature (deg. F) 756 Electrical Hazard Data not available Burning Rate 4.5 mm/min. 

Solutions used to manage body fluids are often administered IV. Before administering an IV solution, the nurse assesses the patient s general status, reviews recent laboratory test results (when appropriate), weighs the patient (when appropriate), and takes the vital signs. Blood pressure, pulse, and respiratory rate provide a baseline, which is especially important when the patient is receiving blood plasma, plasma expanders, or plasma protein fractions for shock or other serious disorders. 

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