Closures, packaging

Packaging Similarly, information on the closure/packaging systems must be provided in terms of material specification, suitability/compatibility with the pharmaceutical product, dimensional specifications, water impermeability, and so on. Defence against microbial contamination should be discussed in the context of either packaging of sterile product or use of preservatives as appropriate. 

SVI formulations are relatively simple, composed of the active ingredient, a solvent system (preferably aqueous), a minimal number of excipients present for reasons described later in this chapter, and the appropriate container and closure packaging system. If the active ingredient is unstable in solution or suspension, the product can be a dry powder, processed either by lyophilization or by sterile crystallization. 

Having or providing adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products. 

Aleff, H.P., A comparison of thermoplastic with thermoset closures, Packaging Technol, April 1982. 

Dickey, J.J., Individually tailor-to-fit seals with aluminium roll-on closures, Packaging Technol., April 1982. 

Completed surveillance reports are transmitted to reactor restart files as part of the QA Closure Package for restart. As an added measure, the Safety Oversight Division (SOD) also reviews the closure process of Charlotte and WISR restart items on a sample basis. 

The following is a list of required documents to be included in the closure package ... 

The RQPT Manager reviews and signs the cover letter to close action on closure packages. The Safety Oversight Division reviews all completed closure packages. 

WSRC, "Control of RQPT Closure Packages," RQPT-I-003, Revision 0. 

The contractor reported in their Issue Closure Package (Reference 56) for topic MS-11, "Health Protection" (dated May 3, 1990), that the requirements of MS-11 had been met. In addition, the contractor provided surveillance reports to substantiate the claim. Further review by DOE indicated the program was functioning adequately and indicated the contractor had met the requirements of this commitment. 

WSRC, WSRC-RP-90-944, "Issue Closure Package, MS-11, Health Protection," May 3, 1990. 

In addition, the DOE staff reviewed the WSRC closure packages associated with staffing and qualification and determined that all items had been adequately addressed and no outstanding issues remained open. 

WSRC, Reactor Restart Review Transmittal P090-001, Issue Closure Package, MS-1, "Logkeeping," January 1990. 

Provide closure packages for each area reviewed. 

WSRC shall perform an independent evaluation/assessment of the readiness for restart. The independent evaluation group shall demonstrate its independence from the ORR organization and develop an evaluation plan to be used to conduct the independent evaluation of the reactor restart readiness. The independent evaluation group shall also assess the ORR effort including (as a minimum) evaluation of the ORR plan, ORR procedures, the ORR tree and checklist items, the ORR checklist item acceptance criteria, ORR team members qualification and training, and ORR closure packages. 

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