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Equipment aseptic areas

Internal fltlings snch as cupboards, drawers and shelves must be kept to a minimum. These may be made fiom stainless steel or a laminated plastic, which may be easily cleaned or disinfected bare wood is to be avoided, although painted or otherwise sealed woodwork m be satisfactory. Stainless steel trolleys can be used to transport eqiripmerrt and materials within the clean and aseptic areas but these must remain confined to then-respective units. Equipment should be so designed as to be easily cleaned and sterilized (or disinfected). [Pg.430]

The air quality in preparation and aseptic areas can be one of the greatest sources of product contamination. However, this problem can be minimized by use of the equipment currently available to provide clean air essentially free from microorganisms and dirt particles. Depth-type filters, electrostatic filters, and dehumidification systems are used to remove the major... [Pg.413]

At the cross point between nonclassihed and classihed areas, as well as between the different classihed areas, separate airlocks for materials and personnel should be installed. Additionally, airlocks to the clean or to the aseptic areas should be equipped with interlocking doors. Only authorized personnel should be allowed to enter the classihed areas. [Pg.155]

There are items that must be transferred into the aseptic processing area that cannot be treated within a sterilizer/oven. These include portable tanks, electronic equipment, and containers of sterile materials (ready-to-use items, sterile powders, environmental monitoring media, etc.). Air locks, pass-throughs, and similar designs are employed in which the exterior surfaces of the items are disinfected. The disinfection process may be completed by personnel outside and/or inside the aseptic area depending upon the specifics of the design. [Pg.125]

Entry to a clean or aseptic area should be through a changing room fitted with interlocking doors this acts as an airlock to prevent influx of air from outside. This route is for personnel only, not for the transfer of materials and equipment. Staff entering the changing room should already be clad in the standard factory or hospital protective clothing. [Pg.383]

It is also essential for equipment to be maintained in a state of cleanliness and sterility between clean-downs. In unprotected environments, contamination by air-borne microorganisms is inevitable. It is normal therefore to house aseptic filling equipment in areas that are protected from the general contaminated natural environment (clean rooms). [Pg.182]

To the extent possible, equipment fittings and services are designed and installed so that operations, maintenance and repairs can be earned out outside the dean and aseptic areas. [Pg.332]

When equipment maintenance is carried out within the dean or aseptic area, dean instruments and tools are used, and the area is cleaned and disinfected before processing recommences if the required standards of deanliness and/or asepsis have not been maintained during the maintenance work. [Pg.333]

Walls, floors, ceilings, and equipment in an aseptic area are cleaned and disinfected in accordance with a written program. The program differentiates between the daily cleaning and disinfection procedures and those undertaken when a different drug is fabricated. [Pg.334]

Articles are sterilized and passed into the aseptic areas by the use of doubled-ended sterilizers equipped with interlocking doors or by another acceptable method. [Pg.334]

As far as possible equipment should be designed and installed so that maintenance and repairs may be carried out without additional personnel having to enter the clean aseptic areas. If maintenance must be carried out within these areas,personnel concerned should receive appropriate training in the elements of microbiology. When within the areas they should be appropriately dressed, and use tools and equipment which have been sterilized as far as possible. Areas entered for maintenance should be cleaned and disinfected before processing recommences if the required standards of cleanliness and/or aseptic have not been maintained during the work. [Pg.434]

A laminar flow enclosure provides a means for environmental control of a confined area for aseptic use. Laminar flow units utilize HEPA filters, with the uniform movement of air along parallel lines. The air movement may be in a horizontal or vertical direction and may involve a confined area, such as a workbench, or an entire room. Laminar flow modules are suspended above filling lines, vial- and stopper-washing equipment, and other processes to provide an aseptic and particulate-free environment. [Pg.414]

Aseptic BPS machines are subject to steam-in-place sterilization following standard CIP cycles. The SIP cycles are routinely measured by thermocouples located in fixed positions along the product pathway. Validation of SIP cycles should be carried out to demonstrate that consistent sterilization temperatures are achieved throughout the equipment to prove that the system can be effectively sterilized. Validation should also identify suitable positions for routine use, or justify the fixed probe positions already in place. The SIP validation is generally carried out with the help of additional thermocouples and should include the use of biological indicators (appropriate for moist heat sterilization). Test locations should include areas which may be prone to air or condensate entrapment. An accurate engineering line drawing of the system to aid identification of suitable test locations and document test locations selected should be available. [Pg.6]

Break of asepsis in the aseptic processing area, or to evaluate changes to procedures, practices or equipment conhguration... [Pg.316]

The stoppers and primary contact filling equipment are transferred from the sterile storage area into a filling room. Eor the filling process, the filtration set-up and filling equipment are aseptically assembled under class 100 conditions in the filling room. [Pg.497]

If terminal sterilization is not possible, aseptic processing must be performed. Aseptic processing is a process that combines presterilized materials and presterilized equipments in a clean area. [Pg.74]

Some sterile powder formulations (these are predominantly, but not exclusively, antibiotics) may require sampling, mixing, milling, and subdivision activities similar to those found in oral powder manufacturing. The facilities and equipment utilized for these products is substantially different from that used for liquids, and the production area bears little resemblance to that utilized for liquids. These materials are received sterile and must be processed through sterilized equipment specifically intended for powder handling in a fully aseptic environment with ISO 5 protection over all open container activities. [Pg.102]

Depending upon the formulations being produced, additional sterilized processing equipment may be present in this area for use in the process. This can include in-line homogenizers, static mixers, and colloid mills. Where sterile powders are produced, the aseptic compounding processes can include blending, milling, and subdivision equipment. [Pg.108]

Aseptic compounding areas typically require a means to introduce sterile equipment, tubing, and other items, so access to a sterilizer is desirable. The aseptic compounding area may be contiguous to the aseptic filling suites. If it is not, separate gowning areas must be provided for personnel as well as separate air locks/pass-throughs (see below). [Pg.108]

In general, extensive use of in-process storage areas should be avoided. It is best to operate the aseptic facility in a just-in-time mode in which components and equipment are sterilized shortly before they are required for use in the filling or compounding areas. Some limited storage is necessary for nonproduct contact materials such as sanitizing agents, environmental supplies and equipment, and other items. [Pg.110]


See other pages where Equipment aseptic areas is mentioned: [Pg.434]    [Pg.29]    [Pg.106]    [Pg.113]    [Pg.382]    [Pg.96]    [Pg.182]    [Pg.335]    [Pg.685]    [Pg.685]    [Pg.84]    [Pg.1232]    [Pg.413]    [Pg.451]    [Pg.6]    [Pg.20]    [Pg.255]    [Pg.492]    [Pg.139]    [Pg.141]    [Pg.179]    [Pg.175]    [Pg.102]    [Pg.107]    [Pg.115]    [Pg.117]    [Pg.118]   
See also in sourсe #XX -- [ Pg.436 ]




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