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Abstract:Maintaining the structure of protein and peptide drugs has become one of the most important goals of scientists in recent decades. Cold and thermal denaturation conditions, lyophilization and freeze drying, different pH conditions, concentrations, ionic strength, environmental agitation, the interaction between the surface of liquid and air as well as liquid and solid, and even the architectural structure of storage containers are among the factors that affect the stability of these therapeutic biomacromolecules. The use of genetic engineering, side-directed mutagenesis, fusion strategies, solvent engineering, the addition of various preservatives, surfactants, and additives are some of the solutions to overcome these problems. This article will discuss the types of stress that lead to instabilities of different proteins used in pharmaceutics including regulatory proteins, antibodies, and antibody-drug conjugates, and then all the methods for fighting these stresses will be reviewed. New and existing analytical methods that are used to detect the instabilities, mainly changes in their primary and higher order structures, are briefly summarized.Keywords: protein drugs; antibody drugs; antibody drug conjugates; pharmaceutical proteins and peptides; stabilization; denaturing stresses; protein aggregation; protein folding; protein drug characterizations; LC-MS
This document or publication is prepared for voluntary acceptance and use within the limitations of application defined herein, and otherwise as those adopting it or applying it deem appropriate. It is not a safety standard. Its application for a specific project is contingent on a designer or other authority defining a specific use. SMACNA has no power or authority to police or enforce compliance with the contents of this document or publication and it has no role in any representations by other parties that specific components are, in fact, in compliance with it.
Nonexclusive, royalty-free permission is granted to government and private sector specifying authorities to reproduce only any construction details found herein in their specifications and contract drawings prepared for receipt of bids on new construction and renovation work within the Untied States and its territories, provided that the material copied is unaltered in substance and that the reproducer assumes all liability for the specific application, including errors in reproduction.
In establishing limitations for these factors, consideration must be given to effects of the pressure differential across the duct wall, airflow friction losses, air velocities, infiltration or exfiltration, as well as the inherent strength characteristics of the duct components. Construction methods that economically achieve the predicted and desired performance must be determined and specified. To the extent that functional requirements for ducts are not identified by test or rating criteria, the construction details here represent acceptable practice in the industry except in special service conditions. Where other construction details are needed to meet the special needs of a particular system design, the designer should comply with appropriate construction standards.
Although some detail and discussion of hood exhaust and dishwasher exhaust is included, systems carrying particulate, corrosive fumes, or flammable vapors or systems serving industrial processes are not covered. Duct systems for residences are not ordinarily subject to the provisions in this document. NFPA Standard 90B, the SMACNA Installation Standards for Heating, Air Conditioning and Solar Systems, the One and Two Family Dwelling Code, and local codes normally have provisions for construction of ducts with different details and service than those shown here.
The listing of certain duct products by recognized test laboratories may be based on the use of a particular joint sealing product. Such a component listing only reflects laboratory test performance and does not necessarily mean that the closure method can routinely be successful for the contractor or that it will withstand in-service operation of the system on a long-term basis.
Surfaces to receive sealant should be clean, meaning free from oil, dust, dirt, rust, moisture, ice crystals, and other substances that inhibit or prevent bonding. Solvent cleaning is an additional expense. Surface primers are now available, but their additional cost may not result in measurable long-term benefits.
The illustrations of fittings, equipment connections, and duct liners in this section presuppose that the designer is familiar with performance data published by organizations such as ASHRAE, AMCA, SMACNA, NAIMA, ACGIH, and coil, damper, air terminal, and fan manufacturers. They assume that system designers understand friction and dynamic losses in HVAC systems and have accounted for these in the design of systems for particular projects.
Unless otherwise indicated, the net free area of the duct dimensions given on the contract drawings shall be maintained. The duct dimensions shall be increased as necessary to compensate for liner thickness.
These provisions apply to ducts used for indoor comfort heating, ventilating, and air conditioning service. They do not apply to service for conveying particulates, corrosive fumes and vapors, high temperature air, corrosive or contaminated atmosphere, etc.
NOTICE: Test procedures 3A and 3B may result in showing compliance with the performance criteria published by SMACNA, and not result in structural failure in the specimen. It is also desirable (but not required) to know the conditions under which failure occurs. If feasible, increase the pressure on the specimen until buckling, permanent deformation, or separation of parts occurs. This will indicate the safety factor of the construction and show the nature of the failure.
Sponsors of new or proprietary transverse joining systems are encouraged to have their tests witnessed and certified by a disinterested responsible party such as a commercial testing laboratory. Recommended construction tables and details should follow a format similar to that used in this manual if an indication of equivalency is intended. Evidence of equivalency should include information on the E1 rigidity classification calculation. SMACNA does not endorse or approve proprietary constructions and does not validate their analysis or tests as being equivalent to SMACNA classifications. Authorities are invited to evaluate such constructions based on evidence presented by their sponsors.
Complete and definitive testing in these three problem areas was not practical under the financial and time limitations of this program. It was instead decided to rely on the judgment of experienced parties to determine the criteria for acceptability. Thirty ventilation contractors and design engineers witnessed various test runs and expressed their opinions on the effects of vibration when the sheets were made to vibrate at 1, 1-1/2 and 2 times the maximum standard (0.01785 in.) (0.4534 mm).
It is not good practice for the duct sheet to come in contact with other parts of a building. It was agreed that the maximum deflection and amplitude values set as standard were reasonable enough to prevent such contact. Where ducts are covered with insulation, vibration transmission by contact is further minimized.
A most interesting set of measurements was obtained in Run No. 6 during which recordings were made at 10 different locations throughout the entire system. The lowest vibration in the system was obtained in the section of duct having the thinnest gage. The readings are not indicative of noise reduction because the frequency characteristic of the noise also changes. The thinner duct appears to sound significantly less loud than the heavier duct. This is in part due to less intensity, but also to the lower pitch or frequency of the sounds.
Thermostatic expansion valves (TXV) are available as parts programs, i.e. with separate valve body and orifice assemblies, or as complete valves (fixed orifice). The category also contains thermostatic injection valves.
The 802.11 standard provides several distinct radio frequency bands for use in Wi-Fi communications: 900 MHz, 2.4 GHz, 3.6 GHz, 4.9 GHz, 5 GHz, 5.9 GHz, 6 GHz and 60 GHz. Each range is divided into a multitude of channels. In the standards, channels are numbered at 5 MHz spacing within a band (except in the 60 GHz band, where they are 2.16 GHz apart), and the number linearly relates to the centre frequency of the channel. Although channels are numbered at 5 MHz spacing, transmitters generally occupy at least 20 MHz, and standards allow for channels to be bonded together to form wider channels for higher throughput.
While overlapping frequencies can be configured at a location and will usually work, it can cause interference resulting in slowdowns, sometimes severe, particularly in heavy use. Certain subsets of frequencies can be used simultaneously at any one location without interference (see diagrams for typical allocations). The consideration of spacing stems from both the basic bandwidth occupation (described above), which depends on the protocol, and from attenuation of interfering signals over distance. In the worst case, using every fourth or fifth channel by leaving three or four channels clear between used channels causes minimal interference, and narrower spacing still can be used at further distances. (The "interference" is usually not actual bit-errors, but the wireless transmitters making space for each other. The requirement of the standard is for a transmitter to yield when it detects another at a level of 3 dB above the noise floor, and when the level is higher than a threshold Pth which, for non Wi-Fi 6 systems, is between -76 and -80 dBm. Interference resulting in bit-error is rare.) 2b1af7f3a8