WATER SYSTEM DOCUMENTATION

It is necessary to maintain accurate blueprints of all water systems for FDA review and to comply with cGMP s. It is also critical to the integrity of the system that the validation be kept current. In order to accomplish these objectives, a change control procedure must be implemented that ensures that all changes to the system are fiilly documented, and all anticipated changes are evaluated by appropriate personnel for potential adverse effects on the system prior to implementation. Based on this evaluation, decisions are made about the need for revalidation to guarantee that the system remains under control. 

With this procedure in place, it is much less likely that the status of the system will be altered haphazardly, and that changes will not occur without the review and consent of appropriate personnel. 

APPENDIX I EXISTING AND PROPOSED U. S. EPA DRINKING WATER STANDARDS 

Contaminants Existing MCL mg/1 Proposed MCL mg/l Best Available Technologies (BAT)3 

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Hydrogen Chloride—Water System. Hydrogen chloride is highly soluble in water and this aqueous solution does not obey Henry s law at ah concentrations. Solubhity data are summarized in Table 5. The relationship between the pressure and vapor composition of unsaturated aqueous hydrochloric acid solutions is given in Reference 12. The vapor—Hquid equiHbria for the water—hydrogen chloride system at pressures up to 1632 kPa and at temperatures ranging from —10 to +70° C are documented in Reference 13. 

For more than 50 years, magnetic devices and other devices have been regularly tested and compared with other water treatment methods, notably chemicals. Although irrefutable, documented evidence of their beneficial effect in industrial water systems still seems sadly lacking, they have enjoyed a profitable share of the water treatment market. 

If all requirements have been satisfied and all validation documents have been approved, the quality assurance managers may release the water system for production use. 

Procedures for operating the water system and performing a routine monitoring program should be established based on the validation study. The procedures should be well documented, detail the function of each job, assign who is responsible for performing the work, and describe how the job is to be conducted. 

The PQ is the phase in which either a technical system is tested over a long period of time (e.g., water system), or a complex technical system is tested overall (connected filling line). For many systems OQ is the last phase performed during qualification. If there are only a few performance tests needed, it might be more practical to include them during OQ or process validation. Combining OQ and PQ decreases the number of documents (less documentation work in the future) and cuts approval time and effort. Again, the procedure for PQ is the same as for IQ and OQ ([develop PQ protocols, approve PQ protocols (by the quality assurance, production, and technical departments), perform PQ, work out the PQ report, and approve the PQ report (by the quality assurance, production, and technical departments)]. The documentation and test description are identical to those in the OQ phase. 

If the purpose of the sampling is to document the static conditions within the water system, fill the sample containers after a small volume of water has been flushed. 

EPA. 1985d. Drinking water criteria document for chromium (Final draft). Report to Criteria and Standards Division, Office of Drinking Water, U.S. Environmental Protection Agency, Washington, DC by ICAIR Life Systems, Inc., Cleveland, OH. NTIS PB86-118072. 

The occurrence of efflorescences should be documented in the field notebook. Samples, in plastic or glass containers, should be sent to the laboratory for chemical analysis. Conceptual models developed for water systems should incorporate the occurrence of efflorescences of observed compositions. 

Initially, the probability that specific chemicals may be present in a water system can be assessed by applying the techniques described in Part B of this document - Identifying specific chemicals. The chapters in Part B, listed in Table 1.1, consider chemicals according to their potential source category. 

Early studies carried out by King and Solms (1982) documented interactions between phenolic compounds and aroma compounds in water systems. They suggested that hydrophobic interactions between aroma compounds and phenolic compounds increased solubility of aroma compounds thereby decreasing the activity coefficient of the aroma compounds. 

Finally, in the discussion of reverse microemulsion systems, mention should be made of one of the most widely studied systems. The surfactant, sodium bis(2-ethylhexyl) sulfosuccinate or Aerosol-OT (AOT), is one of the most thoroughly studied reverse micelleforming surfactants since it readily forms reverse micelle and microemulsion phases in a multitude of different solvents without the addition of cosurfactants or other solvent modifiers. The phase behavior of AOT in liquid alkane/water systems is already well documented. Indeed, the first report of the existence of the formation of microemulsions in a supercritical fluid involved an AOT/alkane/ water system. A The spherical structure of an AOT/nonpolar-fluid/ water microemulsion droplet is shown in Fig. 1. In the now well-known structure, it can be seen that the two hydrocarbon tails of each AOT molecule point outward into the nonpolar phase (e g., supercritical fluid). These tails are lipophilic and are solvated by the nonpolar continuous phase solvent whereas the hydrophilic head groups are always positioned in the aqueous core. 

The Guide to Inspections of High Purity Water Systems, Guide to Inspections of Lyophilization of Parenterals, and also the CGMP document 212.721 Filters state the following ... 

Process water—The water used in BPC production is usually deionized water through the early process stages. If the product is isolated from a water solution in its last step, then a compendial grade of water, purified water or WFI may be utilized depending upon subsequent steps in dosage manufacture and the final use of the product. Cleaning of equipment can be performed with city water, provided the last rinse of the equipment is with the same water utilized in the process step. The validation of water systems has been well documented in the literature (15,16). 

Develop listings for all equipment, processes, and materials including high-usage areas such as HVAC systems, food preparation, laundry, hemodialysis, laboratory equipment, and water-cooled compressors that use water. Provide documentation about the location of all plumbing fixtures. 

The phenomenon of non-freezing water is well documented and is often considered as a measure of bound water. Typically the amount of non-freezing water is a strong function of initial water content. This appears inconsistent with the bound water concept as it would be expected that, above the bound water threshold, the amount of bound water, hence non-freezing water, would remain constant. An alternative model is one in which that non-freezing water arises because the biopolymer/water system is not at thermodynamic equilibrium. As the system is cooled water crystallises out and, if it were an equilibrium S5 tem, at sufficiently low temperatures biopolymer would crystallise out in a eutectic. 

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