Safety and information

In addition to the protection of the material itself, the packaging vial has two other roles  

Pure PAH or PCB compounds Amber vials containing 10 to 100 mg of powdered material 

Soils / sludge / sediment Glass bottles containing 25 to 70 g 

Aquatic/terrestrial plants Glass bottles containing 20 to 30 g 

Biological materials (mussel, fish, etc.) Glass bottles containing 5 to 15 g 

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An SAT toolkit provides resources for the team. The kit includes educational resources on patient safety and information about Children s patient safety agenda. Documents, such as minutes from other SATs, give SAT members a model for their work, and serves to disseminate learnings and innovations across teams. 

Safety and information data on general chemical products... 

TABLE 45.4 Safety and Information Data Sheets on Chemictd Products... 

The Trade Practices Regulations establish the labelling of cosmetics under the authority of the Australian Competition and Consumer Commission (ACCC). The ACCC is responsible for enforcing mandatory consumer product safety and information standards. 

National Institute for Occupational Safety and Health, Information Profiles on Potential OccupationalHa rds, available from the National Technical Information Service, Spriugfield, Va., 1993. 

Two statutory provisions of Tide 21 govern the introduction of new medical devices into the marketplace. Section 515 estabHshes a premarket approval appHcation (PMA) containing data and information demonstrating the safety and effectiveness of a device. Section 510(k) estabHshes a premarket notification process. Under this process, a manufacturer is required to file with the EDA, 90 days before a new device is to be marketed, a premarket notification demonstrating that the device in question is substantially equivalent to a device that was on the market before enactment of the 1976 Amendment and therefore marketable without formal EDA approval. 

MSDS summarizes all of the important health, safety, and environmental information about a substance. A version of this standard also appHes to laboratories, including research and development faciUties, and requires the development of a laboratory hygiene plan. 

Other offices within ODER may become involved in the review process via consults. Eor example, the Office of Epidemiology and Biostatistics analyzes statistical data, the Office of Research Resources provides bioavailabiHty reviews, and the Office of Compliance determines from the results of inspections whether the firms meet EDA s Current Good Manufacturing Practice (cGMP) regulations. Advisory committees composed of independent experts are often asked to meet and further analyze the data. Often they also advise as to what additional data and information may be needed. After PDA s review is completed, PDA issues either a Summary Basis of Approval (SBA) for the dmg or a recommendation against approval. If approved, PDA releases the SBA and a summary of the safety and effectiveness data to the general pubHc. 

Many more suppHers and information about their product line can be obtained from compilations such as the Modem Plastics Pmyclopedia (1) and the Thomas Register of Mmerican Manufacturers (2). The choice of a release agent depends on the process conditions involved and the nature of the contacting substrates (3). Apart from the obvious ease of release, other important requirements are minimal buildup of residues on mold substrate, minimal effect on the molded article, adequate film-forming abiHty, compatibiHty with secondary operations and other processing parameters, health and safety requirements, and cost. 

Occupational Safety and Health. OSHA has set no specific limits for sodium and potassium sibcates (88). A pmdent industrial exposure standard could range from the permissible exposure limit (PEL) for inert or nuisance particulates to the PEL for sodium hydroxide, depending on the rate of dissolution and the concentration of airborne material. Material safety data sheets issued by siUcate producers should be consulted for specific handling precautions, recommended personal protective equipment, and other important safety information. 

Cla.ss II Performance Sta.nda.rds. This category regulates devices for which General Controls are not sufficient to ensure safety and effectiveness. Class 11 controls iaclude all the controls ia Class 1. In addition, manufacturers of sutures ia Class 11 must give the EDA 90-days notice of their iatent to market the suture, by way of a 510(k) filing providing data to show that the suture is "substantially equivalent" to an already-approved device. Most sutures were reclassified iato Class 11 ia 1989. Other than USP standards, performance standards for sutures have not actually been promulgated, but the EDA has taken the stand that sufficient information exists ia the pubHshed Hterature to ensure the safety and effectiveness of sutures ia this class. 

Class III Premarket Approval. Similar to a new dmg approval, a premarket approval grants the appHcant a Hcense to market a specific weU-characterized device. These devices are subject to the requirements of Section 515 of the Eood, Dmg, and Cosmetic Act. A post-amendment device is a device put ia commercial distribution after May 28, 1976. If it is not substantially equivalent to a preamendment device it is automatically ia Class 111, and a premarket approval appHcation (PMA) is required. The appHcation must iaclude reports of preclinical and clinical studies done ia support of claims of safety and efficacy as well as any labeling claims made for the device. Once the PMA is submitted, the PDA determines whether the appHcation iacludes the required information. If the PMA is suitable for scientific review, the PDA has 180 days from the filing date to approve or deny the appHcation. Polybutester, polydioxanone, polyglyconate, and ePTPE sutures are all regulated as Class 111 devices. 

Vinyl acetate is a colorless, flammable Hquid having an initially pleasant odor which quickly becomes sharp and irritating. Table 1 Hsts the physical properties of the monomer. Information on properties, safety, and handling of vinyl acetate has been pubUshed (5—9). The vapor pressure, heat of vaporization, vapor heat capacity, Hquid heat capacity, Hquid density, vapor viscosity, Hquid viscosity, surface tension, vapor thermal conductivity, and Hquid thermal conductivity profile over temperature ranges have also been pubHshed (10). Table 2 (11) Hsts the solubiHty information for vinyl acetate. Unlike monomers such as styrene, vinyl acetate has a significant level of solubiHty in water which contributes to unique polymerization behavior. Vinyl acetate forms azeotropic mixtures (Table 3) (12). 

General In comparison with design information on blowdown drums and cyclone separators, there is very httle information in the open technical hterature on the design of quench tanks in the Chernies industry. What is available deSs with the design of quench tanks (Sso called suppression pools) for condensation of steam or steam-water mixtures from nuclear reactor safety vSves. Information and criteria from quench tanks in the nuclear industry can be used for the design of quench tanks in the chemicS industry. There have been sev-... 

The book does not focus on occupational safety and health issues, although improved process safety can benefit each area. Detailed engineering designs are outside the scope of the book. This book intends to identify issues and concerns in batch reaction systems and provides potential solutions to address these concerns. This should be of value to process design engineers, operators, maintenance personnel, as well as members of process hazards analysis teams. While the book offers potential solutions to specific issues/concerns, ultimately the user needs to make the case for the solutions that best satisfy their company s requirements for a balance between risk reduction and cost. In many instances the book provides one or more sources of additional information on the subject which could be of value to the reader. 

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