Usp Lab Manual
PortaFab specializes in the turn-key design and construction of modular clean rooms including applications specifically requiring USP 797 compliance. Our in-house team of engineers, architects and designers will provide assistance with the design and qualification process, while our nationwide network of local distributors will complete the construction and installation of your new enclosure. What is USP 797?
USP 797 is a far-reaching regulation that applies to health care institutions, pharmacies, physicians practice facilities, and other facilities in which compound sterile preparations are prepared, stored, and dispensed. The purpose of the regulation is to prevent infections in patients using pharmaceutical products, as well as to protect pharmacy staff members that are ordinarily exposed to pharmaceutical products. Below is a summary of the USP 797 regulation. For more information, visit the. You can also download the entire ASHP Discussion Guide for Compounding Sterile Preparations document.
Summary of USP 797: Pharmaceutical Labs & Sterile Compounding Source of base information: Pharmacopeial Form - Volume 29 (4) July - August 2003 Effective Date: January 1, 2004 FDA enforceable: yes Scope - 'The content of this chapter applies to health care institutions, pharmacies, physicians practice facilities and other facilities in which compounds sterile preparations are prepared, stored and dispensed.' Facilities Impacted by USP 797.
Facilities in which sterile products are prepared according to the manufacturer's labeling and where manipulations are performed during the compounding of sterile products which increase the potential for microbial contamination of the end product. Facilities where products are compounded using devices or ingredients which are not sterile to prepare products which must be sterilized prior to use. Products may be biologics, diagnostics, drugs, nutrients, or radiopharmaceuticals which include, but are not limited to, baths and soaks for live organs and tissues, implants, inhalations, injections, irrigations, metered sprays, ophthalmic and otic preparations.
Microbial Contamination Risk Levels Low Risk Conditions: Compounding with aseptic manipulations entirely with ISO Class 5 or better air quality using only sterile ingredients, products, compounds and devices. Examples:. Using sterile needles and syringes to transfer sterile drugs from the manufacturer's original packaging (vials, ampoules). Manually measuring and mixing no more than three sterile products to compound drug admixtures and nutritional solutions. Medium Risk Conditions: Multiple individual or small doses of sterile products are compounded or pooled to prepare a compound sterile product that will be administered either to multiple patients or to one patient on multiple occasions. The compounding process includes complex aseptic manipulations other than the single volume transfer.
The compounding process requires and unusually long duration, such as that required to complete dissolution or homogenous mixing. The compounded sterile products do not contain broad spectrum bacteriostatic substances and they are administered over several days. For a medium risk preparation in the absence of passing a sterility test, the storage period cannot exceed the following time periods: 30 hours at room temperature, 7 days at cold temperature, and 25 days in a solid frozen state at -20 C or colder Examples:. TPN fluids compounded using manual or automated devices requiring multiples injections, detachments, and attachments of the nutrient source products to the device or machine to deliver all nutritional components to the final sterile container.
Filling of reservoirs of injection and infusion devices with multiple sterile drug products and evacuations of air from these reservoirs before the filled device is dispensed. Filling of reservoirs of injection and infusion devices with volumes or sterile drug solutions that will be administered over several days at ambient temperatures between 25 and 40 degrees. Transfer of multiple ampoules or vials into a single final sterile container or products. High Risk Conditions: Non-sterile ingredients including manufactured products for routed of administration other than those listed under c in the in introduction are incorporated or a non-sterile device is employed before terminal sterilization. Sterile ingredients, components, devices and mixtures are exposed to air quality inferior to ISO Class 5.
This includes storage in environments inferior to ISA Class 5 of opened or partially used packages or manufactured sterile products that lack antimicrobial preservatives. Non-sterile products are exposed to air quality inferior to ISA Class 5 for at least 6 hours before sterilization. For high risk preparations in the absence of passing a sterility test the storage periods cannot exceed the following; 24 hours at controlled room conditions, 3 days at cold temperatures and 45 days for solid frozen state at -20 C or colder. Examples:. Dissolving non-sterile bulk drug and nutrient powders to make solution, which will be terminally sterilized. Sterile ingredients, components, devices, and mixtures are exposed to air quality inferior to ISO Class 5.
This includes storage in environment inferior to ISO Class 5 of opened or partially used packaged of manufactured sterile products that lack antimicrobial preservatives. Measuring and mixing sterile ingredients in non-sterile devices before sterilization is preformed. Personnel Training and Evaluation in Aseptic Manipulations Skills Personnel who prepare compounded sterile products must be provided with appropriate training from expert personnel, audio-video instructional sources, or professional sour-ces before beginning to prepare products. Personnel shall perform didactic review, writ-ten testing, media fill testing or aseptic manipulative shills initially and at least annually for low and medium risk levels and semi annually for high risk level compounding.
Media fill challenge testing will be used to access the quality of aseptic skills. Clean Rooms Low and Medium Risk:. Must have an ante area but need not be separated with a physical wall. Air classification or quality must meet ISO class 8 standards Class 100,000 (ISO 8).
Positive pressure to adjacent areas per ISO 14644-4. Physical characteristics of construction: Walls, floors, fixtures and ceilings should be smooth, impervious and free of cracks, crevices and non-shedding. Surfaces should be resistant to damage from sanitizing agents. Junctures of ceilings to walls should be coved and caulked. If ceilings consist of inlaid panels, the panels should be impregnated with a polymer to render them impervious and hydrophobic and they should be caulked around each perimeter to seal them to the support frame. Walls may be panels locked together and sealed or epoxy coated gypsum board. Floors should be overlaid with side sheet vinyl flooring with heat-sealed seams and coving at the sidewall.
Polaris 1992, 1993, 1994, 1995, 1996, 1997 & 1998: 1992: SL650 (SL-650) - 1993: SL650 (SL-650), SL750, SLT - 1994: SL650, SL750 (SL-750), SLT - 1995: SL650 (SL650 International), SL650 STD (SL650 STD International), SL750 (SL750 International). 1997 polaris slt 780. 1993 wave runner jetski manual1994 kawasaki 650 sx jetski 1994 kawasaki jetski 750sx service manual 1994 kawasaki jetskit 750sx owners manual 1995 - 1997 kawasaki jetski 900zxi / 750zxi watercraft service manual 1995 1996 1997 kawasaki jetski 750 900 zxi service repair manual1996 polaris780jetski no spark 1997 polaris jetski owners manual 1997 polaris. jetski manuel 1997 honda aquatrak jetski owners manual 1999 polaris jetski backfire 1999 yamaha jetski manual 2000 yamaha 1300 jetski manual 2001 polaris 800 jetski engine 2001 polaris jetski no spark 2002 kawasaki jetski carberator vent stack. SLTl50 (SLTl50 International), SLX780 (SLX-780 International) - 1996: SL700 (SL-700 International), SLTlOO (SLTlOO International), SL780 (SL780 International), SL900 (SL-900 International), SLX780 (SLX780 International), SLTl80 (SLTl80 International), Hurricane (Hurricane International), SLTX (SLTX International) - 1997: SL700, SL700 Deluxe, SLT700 Hurricane, SL780, SLTl80, SLX PRO 785, SL900, SL1050 SLTX - 1998: SLH, SLTH, SLXH, SLTX.
The buffer or ante area should contain no sinks or floor drains. Gowning: Before entering the ante or buffer area personnel should remove outer lab coats, make-up, and jewelry, and thoroughly scrub hands and arms to the elbows. After drying hands and arms they should don clean non-shedding uniforms consisting of: Hair covers, Shoe covers, Coveralls or knee length coats (coats to fit snuggly at the wrists and be zipped or snapped in the front), Appropriate gloves, Facemasks should be put on after entering the cleanroom. Leaving and Reentry: Upon leaving the clean room the coveralls or coats should be carefully removed and hung outside the entry in the buffer area. Coveralls and coats can be used for one shift.
All other coverings are to be discarded and new ones donned prior to reentry. Reentry follows original procedure.
Usp Lab Manual Vtu
High Risk:. All of the low to medium risk procedures and facilities excepts the ante area must be a separate room. Barrier Isolator (MIC) A well-designed barrier isolator is an alternative to an ISO class 5 (class 100) LAFW device in an ISO class 8 clean room. The barrier isolator should be supported by adequate procedures for operation, maintenance, monitoring, and control. It is not necessary to locate the barrier isolator in an ISO class 8 area. Gowning: Hair covers, Shoe covers, Lab Coats, Facemasks (for covering facial hair). Quality Assurance Program Must have formal audit program which:.
Is formalized in writing. Considers all aspects of preparation and dispensing. Describes specific monitoring and evaluation activities. Has specifications on how results are to be reported and evaluated. Identifies appropriate follow-up mechanisms when action limits or thresholds are exceeded. Has delineation of the individual responsible for each aspect of the QA program. USP 797 Guidelines - Minimum Requirements for Validation Low to Medium Risk:.
Usp Lab Manual 6th Sem
Personnel validation - Three consecutive media fill runs without contamination.