Manufacturers instructions

The manufacturing instructions and formula for a typical commercial resole to be used in a plywood adhesive application are shown in Table 2. Such resin... 

Equipment should be purchased from reputable manufacturers. They should be located at clearly defined fire points. All equipment should be recharged after it has been used. Manufacturers instructions for maintenance and recharging must be followed closely. Regular inspection and maintenance of all firefighting equipment is essential, otherwise it is liable to deteriorate and prove unserviceable when needed. 

The correct tools, equipment and manufacturers instructions are available ... 

To determine whether human testing for a new drug or new drug product is reasonable, it is first necessary to conduct preclinical studies and to submit the IND. The necessary information needed to prepare the IND is outlined in Table 1. The IND is to contain information on appropriate prior animal studies for safety evaluation, any available clinical data, adequate drug identification and manufacturing instructions, and a detailed outline of the proposed clinical study, routs of administration, approximate number of patients to be used, and an estimate of the length of treatment and an environmental impact statement. 

They have verified the mutual compatibility of the devices in accordance with the manufacturers instructions and have carried out their operations in accordance with these instructions. 

Deliver shock (based on manufactures instructions (if unknown biphasic-200J, monophasic-360J)... 

Manufacturing formulae should clearly indicate the product name, potency or strength, and exact batch size. It lists each of the starting raw materials required, and the quantity in which each is required. The processing instructions should contain step-by-step manufacturing instructions. The detail given should be sufficient to allow a technically competent person, unfamiliar with the process, to successfully undertake the manufacturing procedure. 

Procedures for testing asphalt shingles resistant to wind blowup/blowoff when applied on low slopes in accordance with manufacturer instructions. Shingles are Type I, factory-applied adhesive (self-sealing shingles) and Type II, lock-type, with mechanically intedocking tabs (ears). 

Manufacturing instructions are at hand during processes and are approved and accurately followed. 

Check that all components of AHU have been installed per manufacturer instruction. 

A suitable holding tank is sterilized in place by steam. The following sterilized parts are aseptically connected to the tank a blender valve, a safety relief valve, and a vent filter assembly containing a 0.2 im filter. Prepare the media according to manufacturer instruction. Adjust pH. 

Media are prepared per manufacturer instruction. Adjust the pH. The sterilization procedure is conducted per related MFM (manufacturing formula and method) for media fill mn. 

Reconstitute and store the CSE according to manufacturer instructions. The potency of CSE specihed by the manufacturer should be confirmed. Constitute the entire contents of one vial of CSE with LAL reagent water (LRW) and mix intermittently for 30 min, using a vortex mixer. Water should come in contact with all internal surfaces, including stopper sometime during reconstitution. 

Comparison of the relevant preapproval batch or batches and proposed commercial production batches CDER chemists are responsible for the comparison of the formulation, manufacturing instructions, and associated in-process and Qnished product tests and specifications established for the relevant preapproval batch or batches with the proposed commercial production batch to determine the acceptability of the firm s proposed scale-up procedure. The Field will compare the process used to make the preapproval batches with the actual process used to manufacture the validation batches. Significant differences in these processes will be evaluated by CDER s Office of Compliance, to determine whether the differences constitute fraud, and by the reviewing officers, to determine whether differences in the processes will affect the safety and effectiveness of the resulting product. 

For sequencing peptides containing natural amino acids, the manufacturers instructions are followed. For sequencing peptides consisting of both natural and unnatural amino acids, a slightly modified gradient program and modified method are employed (refer to Tables I and II). 

Oscillation of the dried granulation and lubricant was accomplished in every instance using a no. 10 wire screen. Reference to the no. 12 screen, the alternative method for pulverizing the batch, must be deleted from the manufacturing instructions for the process to be validated retrospectively. 

Manufacturing instructions are the written procedures that personnel follow during actual product batch preparation. The instructions must document the modular equipment and materials to be used as well as the unit operations to be performed. (See Figs. 3 and 4.) The master document should also include step-by-step manufacturing instructions as well as GMP-required elements previously listed under the section on batch records. 

Describe the detailed procedure to be followed to check the calibration of the instrument over its certified operating range and process failure limits (to ensure that it is within the tolerances specified in the manufacturer instruction manual and aligns with the requirements specified in the respective instrument specification/data sheet). 

Streptavidin HRP use in accordance with the manufacturers instructions. Numerous companies sell Streptavidin-HRP, including Sigma, Becton Dickinson, and Biosource. 

Dilute streptavidin-HRP according to manufacturers instructions. Add 100 pL per well. Incubate at room temperature for 30 min. 

Before going out in the field, confirm that the manufacturers instructions are enclosed... 

The simplest method for determination of cytokines by ELISA is to use commercially available kits with matching antibody pairs and standards for the specific cytokine. The reader can consult web sites such as http //www.biocompare.com/ to select from a wide range of commercially available kits with the corresponding manufactures instructions for use. 

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