Sterile filling

Steric stabilization Sterilant Sterilants Sterile filling Sterile filtration... 

In rare instances it is possible to sterilize an article at the time and place of its use. However, steriliza tion generally takes place at one location prior to use of an article at another location. The main purpose of packaging (qv) is to protect the stetiHty of the contents. When an article is placed in its protective container and subsequentiy sterilized, the process is called terminal sterilization. When it is sterilized first and then placed in a presterilized container, the process is called sterile filling. 

The most widely used sterilization method ia the food industry is moist heat. The heat is usually suppHed by high pressure steam, but because most foods already contain moisture the role of steam is to heat the food to the required temperature. The cooking and sterilization processes can frequendy be combined into one. The food may be sealed into impervious containers of glass, metal, or plastic film and undergo terminal sterilization, or it may be presterilized in batches or in a continuous operation and then filled into a presterilized container. The latter process is called sterile filling. 

Goodwin Biotechnology, Inc. (GBI) is a fully integrated GMP contract manufacturer of mammalian cell products providing process development (upstream and downstream) and cell banking through production, purification, and sterile fill. The downstream... 

Glass vials are received from the warehouse and enter the washing area. The vials are washed in a validated vial washer, using deionized water and water for injection with sterile compressed air. The vials are depyrogenated in a validated laminar flow dry heat tunnel and unloaded into the sterile filling room under laminar flow. 

Ready to sterilize) Filling occurs in controlled access rooms (level I, class 100) equipped with vertical flow HEPA filtration at the process steps. HEPA filters are located in the classified area over and around the container in-feed and filling/stoppering equipment. Shrouds are attached to the perimeter of the HEPA filter housing and extend below the equipment work surface to maintain air quality of the critical area (level I, class 100) for the filling lines. 

Following validated equipment was used for the solution preparation, vial preparation, sterilization, filling, and freeze-drying during the media-fill simulation of 15-ml vials. 

Run 1, Run 2, and Run 3 Media preparation vial washing/stoppers sterilization filling and loading ... 

Process validation Inspection of the establishment to determine compliance with cGMP requirements and adherence to application requirements is a Field responsibility. CDER may request data to support validation of sterile processing operations for example, environmental monitoring, equipment validation, sterile fill validation, and associated sterile operations. 

There are several machine systems available for aseptically filling glass and plastic bottles for still juices. (Aseptic filling of drink cartons is covered in Section 9.7.) Carbonated drinks are not aseptically filled. There are two main aseptic filling workflows, with a third workflow used less frequently. The first system sterilises the container, fills and seals it the second takes a sealed, precleaned bottle, removes the seal in a sterile environment, fills and re-seals the container. The third system blows a bottle and while it is still sterile fills it and then seals it, all within the same machine, this is known as a form-fill-seaF (FFS) system. 

There may be need only to fill, close, and identify the primary container (as used for many sterile filling operations) and then store the filled primary containers for later packaging. This can create many problems for example... 

The containers must first be unscrambled. Watch out for induced dirt from friction, fracture of fragile containers, and static electricity from dry conditions and movement of plastics, which can attract small dust particles from the surrounding air. Most containers used for sterile filling (ampules, vials, bottles, and collapsible tubes) will be brought to the fdling line in precleaned and sterilized trays, so unscrambling might not be necessary. There are also certain types of outer cleaned bottles that are supplied in clean layers, with the outer plastic protection removed online. 

EBRS for the sterile filling plants, capsule filling plant, and tablet compressing plant... 

In industry, the LFCB is used to conduct small batch sterile filling operations, in the general manipulation and isolation of non-hazardous materials, and in quality assurance/quality control (QA/QC) sterility testing. 

In industry, the BSC is used to conduct small batch sterile-fill operations, manipulation (weighing and pouring), isolation of hazardous materials, and in QA/QC testing applications. All classes of BSC are encountered in pharmaceutical manufacturing operations for a wide variety of processing applications. 

Fig. 8-7. Sulphur gas concentrations (ppb by volume) from the decomposition of 20 g of 40-80 mesh pyrite under saturated conditions sterile (open circles) non-sterile (filled circles) (from Taylor et al., 1982).

In finished product manufacturing areas, production personnel should be evaluated twice a year for their ability to maintain the sterility of the product by undergoing media fills where each employee manipulates sterile filling equipment and fills 300+ vials aseptically with sterile culture media. Additionally, personnel should be monitored daily for levels of contamination by ROD AC contact plates on fingers and other parts of the sterile gown. This requirement is becoming standard practice for bulk manufacturing personnel. 

Friday Control inoculum cultures and CellBag for sterility. Fill inoculum into inoculum bottle under laminar flow. Inoculate the culture with final density of approx. 3x10 cells mL . Start stop watch. Rocking rate= Inoculum 20 min angle = culture should 7.5° temperature= be at 2.5-3.0x10 28 °C set air flow cells mL to 3 Lh . ... 

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