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Of the highest concern are the inhalation drug products [orally inhaled and nasal drug products (OINDPs)] [124, 127, 128], which include metered-dose inhalers (MDIs), dry powder inhalers (DPIs), inhalation solutions and sprays, and nasal sprays The FDA considers leachables to be a safety concern for OINDPs Leachables are also of concern for injections and injectable suspensions, sterile powders and powders for injection, ophthalmic solutions and suspensions, and transdermal ointments and patches Other dosage forms such as liquid and solid oral are of less concern [8].

There are many challenges (mainly scienti c) for pharmaceutical development programs and teams regarding leachables and extractables in terms of analysis and questions such as: At what levels are drug product leachables of safety concern What safety quali cation processes can be applied to leachables How do you develop control strategies (including speci cations and acceptance criteria) for leachables Can you control drug product leachables by controlling potential leachables (ie, extratables) [128] A report has shown that The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group proposed a complete pharmaceutical development process for OINDPs related to leachables and extractables [129] based on its own comprehensive scienti c research and on some earlier proposals from the International Pharmaceutical Aerosol Consortium for Regulation and Science [130].

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The PQRI recommendations also discuss selection criteria for OINDP container closure components which are designed to exclude potential leachables of known safety concern and minimize both the numbers and levels of other potential leachables It is believed that these recommendations move beyond quality by testing paradigm and suggest a process by which quality is designed into OINDP container closure system components (quality-by-design paradigm) [128] Extractable and leachable testing studies are recommended even if the containers or closures meet compendial suitability tests..

Antenna Gain (dBi)

A cluster has servers (active or passive), heartbeat cables, and hubs (if necessary) for private network, connections to the public network, and shared and private disks. During failover, the ownership of the shared disks, cluster IP address, and applications move the failed server to the takeover cluster member. When connecting shared SCSI devices, each device, including the HBAs in the chain, must have unique SCSI IDs.

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Figure 14.27. Schematic of steel mill blast furnace showing injection point for supplemental fuels and reductants such as postconsumer plastics [134].

Because the preceding samples don t have a speci c day associated with them, Excel (by default) uses a date serial number of 0, which corresponds to the nonday January 0, 1900. Often, you ll want to combine a date and time. Do so by using a recognized date-entry format, followed by a space, and then a recognized time-entry format. For example, if you enter 6/18/2010 11:30 in a cell, Excel interprets it as 11:30 a.m. on June 18, 2010. Its date/time serial number is 40347.479166667. When you enter a time that exceeds 24 hours, the associated date for the time increments accordingly. For example, if you enter 25:00:00 into a cell, it s interpreted as 1:00 a.m. on January 1, 1900. The day part of the entry increments because the time exceeds 24 hours. Keep in mind that a time value without a date uses January 0, 1900, as the date. Similarly, if you enter a date and a time (and the time exceeds 24 hours), the date that you entered is adjusted. If you enter 9/18/2010 25:00:00, for example, it s interpreted as 9/19/2010 1:00:00 a.m. If you enter a time only (without an associated date) into an unformatted cell, the maximum time that you can enter into a cell is 9999:59:59 (just less than 10,000 hours). Excel adds the appropriate number of days. In this case, 9999:59:59 is interpreted as 3:59:59 p.m. on 02/19/1901. If you enter a time that exceeds 10,000 hours, the entry is interpreted as a text string rather than a time.

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