30 Containment systems Dose

Powder container. Dry powder inhalers may contain the dry powder formulation in many different forms. The first DPI, the Spinhaler contained single doses in capsules. Other systems, like the Diskus or Diskhaler may contain the metered dose in blisters, whereas systems like the Turbohaler , or Novolizer , have multi-dose containers. 

A change from a single unit dose container to a multiple dose container system. 

The physicochemical properties of the drug are critical in the design of the dosage form. Solubility, stability, and pH can strongly affect whether a drug can be delivered effectively from a controlled delivery device. Because sustained-release devices often contain multiple doses that if released immediately would reach toxic levels, the physicochemical properties and formulation process may have to be more tightly controlled compared with immediate-release systems. 

Unit-dose systems offer the easiest technical solution to this problem, but have the disadvantages of higher cost of manufacture and of not being as compact as a multidose product containing equivalent doses. Unit-dose products are usually made of low-density polyethylene (LDPE), with the formulated sterile solution being without a preservative, and sealed using the form-fill-seal process. 

Topical aerosols and nasal sprays rely on pump systems to deliver the API in the form of finely dispersed mist or as coarse spray or stream of semisolid. Because of their design, aerosol and nasal products are usually under very high pressure, and this makes it difficult to obtain suitable samples for analysis. In spite of that, a number of very specialized tests which include pressure test, minimum fill, number of discharges per container defivered dose uniformity, delivery rate, leak test, spray pattern and plume geometry test, assay, and microbial enumeration test (MET) have been devised to test the integrity of the aerosol package and the device used to defiver the dose. ... 

A. 1218. All normal potential radiation sources (contained and airborne) due to reactor operation and all potential radiation sources throughout the facility that can be identified shall be catalogued in this section. These sources are used as bases for shielding calculations, design of ventilation systems, dose assessment, waste management and determination of effluent releases. 

A second approach modifies the CA resist chemistry. Eor example, researchers have introduced basic additives into the resist formulation to minimize the impact of surface contamination of the resist film (82,83). A resist that already contains added base (and consequendy requites a larger imaging dose) should be less affected by the absorption of small amounts of basic contaminants. Systems of this type have been claimed to have improved resolution as well. The rationalization here is that the acid that diffuses into the unexposed regions of the resist film is neutralized and does not contribute to image degradation (84,85). 

Transfusion-induced autoimmune disease has been a significant complication in the treatment of patients who require multiple platelet transfusions. Platelets and lymphocytes carry their own blood group system, ie, the human leukocyte antigen (HLA) system, and it can be difficult to find an HLA matched donor. A mismatched platelet transfusion does not induce immediate adverse reactions, but may cause the patient to become refractory to the HLA type of the transfused platelets. The next time platelets with an HLA type similar to that of the transfused platelets are transfused, they are rejected by the patient and thus have no clinical efficacy. Exposure to platelets originating from different donors is minimized by the use of apheresis platelets. One transfusable dose (unit) of apheresis platelets contains 3-5 x 10 platelets. An equal dose of platelets from whole blood donation requires platelets from six to eight units of whole blood. Furthermore, platelets can be donated every 10 days, versus 10 weeks for whole blood donations. 

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