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Filling: aseptic

The aseptic processor either feeds the filler directly, with excess flow returning to the balance tank (and positive flow maintained under all circumstances), or feeds directly to an aseptic storage tank, which acts as a buffer between the processing and filling operations. [Pg.187]

The cleaning regime specified for the containers will depend on their initial level of contamination. Normally heat (steam or hot air) or chemical means (hydrogen peroxide or oxonia) are used sometimes these are used in combination with ultraviolet radiation. [Pg.188]

Laminate board packs are made either from flat reels of material or from preformed blanks. These systems are generally tied , that is, the laminate supplier also makes the filling equipment. The fillers are well proven microbiologically and do not need to be placed within a special environment. [Pg.188]

Bottle systems are more varied, whether for glass, polyethylene terephtha-late (PET) or other plastic. Bottles are rinsed with oxonia solution and then sterile water prior to filling. The filler is generally of a non-contact type (it does not touch the bottles) and product is either weighed in or measured volumetrically. Caps are also chemically sterilised (unless a foil closure is used) and applied on a capper monoblocked with the filler, enclosed in a high efficiency pure air (HEPA) filtered enclosure. The filler and final rinser are in a class 100 room and file operator wears full protective clothing to prevent infection of the product. [Pg.188]

There are some more specialised systems for PET bottles, cans, other plastic bottles, form-fill-seal packs and returnable PET or glass bottles for still and carbonated drinks (generally high acid). These are material-dependent solutions and each arises from the limitations and properties of the materials and the way they are formed into containers. [Pg.188]


There are four types of food sterilization processes terminal sterilization in prefiUed containers in a batchwise process terminal sterilization in prefiUed containers of appropriate design heated to the required temperatures in a continuous process aseptic filling foUowing batchwise cooking in an appropriate retort and aseptic filling in a continuous cooking system equipped with appropriate valves to aUow the necessary pressures for attainment of the required sterilization temperatures. [Pg.411]

Grade A is the highest standard, and is required for local zones where high-risk tasks are carried out. Examples are the aseptic filling of a product following filtration through a 0.22 pm filter to render it sterile, and general aseptic manipulations. This is usually achieved by the use of cabinets or hoods that enable laminar airfiow patterns to be established. [Pg.218]

Under no circumstances should living cultures of microorganisms, whether they be for vaccine preparation (Chapter 16) or for use in monitoring sterilization processes (Chapter 23), be taken into aseptic areas. As already pointed out, separate premises are needed for the aseptic filling of live or of attenuated vaccines. [Pg.436]

Sterile filtration, with subsequent aseptic filling, is common because of the heat sensitivity of many drugs. Those drug solutions that can withstand heat should be terminally autoclave sterilized after filling, since this best assures product sterility. [Pg.396]

In the first example, procaine penicillin, an aqueous vehicle containing the soluble components (such as lecithin, sodium citrate, povidone, and polyoxyethylene sorbitan monooleate) is filtered through a 0.22 pm membrane filter, heat sterilized, and transferred into a presterilized mixing-filling tank. The sterile antibiotic powder, which has previously been produced by freeze-drying, sterile crystallization, or spray-drying, is aseptically added to the sterile solution while mixing. After all tests have been completed on the bulk formulation, it is aseptically filled. [Pg.397]

Because of these product sensitivities, most ophthalmic pharmaceutical products are aseptically manufactured and filled into previously sterilized containers in aseptic environments using aseptic filling-and-capping techniques. This is the case for ophthalmic solutions, suspensions, and ointments, and specialized technology is involved in their manufacture. [Pg.449]

Bio-Concept Laboratories Inc. is a comprehensive facility with infrastructure for supporting product development and delivery projects, which operates on a customer contract basis. Chemical, biochemical, and microbiological are addressed in a complete aseptic fill suite for the customized manufacture of sterile clinical and toxicology products. [Pg.260]

Filtration of the final product through a 0.22 pm absolute filter in order to generate sterile product, followed by its aseptic filling into final product containers. [Pg.159]

Purification entails use of an immunoaffinity column containing immobilized murine antifactor VII antibody. It is initially produced as an unactivated, single-chain 406 amino acid polypeptide, which is subsequently proteolytically converted into the two-chain active factor Vila complex. After sterilization by filtration, the final product is aseptically filled into its final product containers, and freeze-dried. [Pg.340]

After its purification, sterile filtration and aseptic filling, human urokinase is normally freeze-dried. Because of its heat stability, the final product may also be heated to 60 °C for up to 10 h in an effort to inactivate any undetected viral particles present. The product utilized clinically contains both molecular mass forms, with the higher molecular mass moiety predominating. Urokinase can also be produced by techniques of animal cell culture utilizing human kidney cells or by recombinant DNA technology. [Pg.351]

HSA is used therapeutically as an aqueous solution it is available in concentrated form (15-25 per cent protein) or as an isotonic solution (4-5 per cent protein). In both cases, in excess of 95 per cent of the protein present is albumin. It can be prepared by fractionation from normal plasma or serum, or purified from placentas. The source material must first be screened for the presence of indicator pathogens. After purification, a suitable stabilizer (often sodium caprylate) is added, but no preservative. The solution is then sterilized by filtration and aseptically filled into final sterile containers. The relative heat stability of HSA allows a measure of subsequent heat treatment, which further reduces the risk of accidental transmission of viable pathogens (particularly viruses). This treatment normally entails heating the product to 60 °C for 10 h. It is then normally incubated at 30-32 °C for a further 14 days and subsequently examined for any signs of microbial growth. [Pg.355]

Addition of excipients (sucrose), filtration and aseptic filling... [Pg.385]

Sterile filtration and aseptic filling into final product container... [Pg.403]

Because of the level of automation of the entire process, little human intervention is required during manufacture compared to traditional aseptic filling and it is considered an advanced aseptic filling process. It is therefore possible to achieve very high levels of sterility confidence with a properly configured BFS machine designed to fill aseptically. [Pg.1]

As with traditional aseptic filling, in order to comply with pharmaceutical GMP, it is important to minimize contamination at all stages of manufacture. Raw materials should be of a high quality and tested for microbial contamination. Water used for product manufacture should be of low bioburden and high purity (preferably water-for-injection quality, although this requirement is dependent upon the nature of the product being manufactured). [Pg.4]

There is no appropriate defined sterility confidence level which can be translated directly into acceptance criteria for broth fill contamination for BFS processes. The most commonly recognized acceptance criterion is a sterility assurance level (SAL) of 10 although modem aseptic filling techniques such as BFS can achieve a higher SAL. This should be reflected by broth fill results and acceptance criteria for this advanced technology. [Pg.6]

Prequency and size of broth fills must be clearly defined. The size of fill is usually based upon the statistical probability of detecting an acceptably low incidence of microbial contamination. Tables have been published to this effect [4], but the BPS operator has to decide both size and frequency of broth fills based upon their speeifie facility, routine product batch sizes, and operation. Por high speed BPS maehines used for filling routine produet batehes in excess of 100,000 units, broth fill batehes larger than traditional aseptic filling lines are both feasible and appropriate. [Pg.7]

Downstream processing is normally undertaken under clean room conditions, with the final steps (e.g. sterile filtration and aseptic filling into final product containers) being undertaken under Grade A laminar flow conditions (Figure 3.18). [Pg.136]

Figure 3.29. Photographic representation of a blow-fill-seal machine, which can be particularly useful in the aseptic filling of liquid products (refer to text for details). While used fairly extensively in facilities manufacturing some traditional parenteral products, this system has not yet found application in biopharmaceutical manufacture. This is due mainly to the fact that many biopharmaceutical preparations are sold not in liquid, but in freeze-dried format. Also, some proteins display a tendancy to adsorb onto plastic surfaces. Photo courtesy of Rommelag a.g., Switzerland... Figure 3.29. Photographic representation of a blow-fill-seal machine, which can be particularly useful in the aseptic filling of liquid products (refer to text for details). While used fairly extensively in facilities manufacturing some traditional parenteral products, this system has not yet found application in biopharmaceutical manufacture. This is due mainly to the fact that many biopharmaceutical preparations are sold not in liquid, but in freeze-dried format. Also, some proteins display a tendancy to adsorb onto plastic surfaces. Photo courtesy of Rommelag a.g., Switzerland...
Purification entails use of an immunoaffinity column containing immobilized murine antifactor VII antibody. It is initially produced as an unactivated, single chain 406 amino acid polypeptide, which is subsequently proteolytically converted into the two-chain active factor Vila complex. After sterilization by filtration, the final product is aseptically filled into its final product containers and freeze-dried. The excipients present in the product include sodium chloride, calcium chloride, polysorbate 80, mannitol and glycylglycine. When freeze-dried in the presence of these stabilizing substances and stored under refrigerated conditions, the product displays a shelf-life of at least 2 years. It has proved effective in the treatment of serious bleeding events in patients displaying anti-factor VIII or IX antibodies. [Pg.371]


See other pages where Filling: aseptic is mentioned: [Pg.459]    [Pg.411]    [Pg.435]    [Pg.446]    [Pg.393]    [Pg.413]    [Pg.166]    [Pg.166]    [Pg.197]    [Pg.227]    [Pg.324]    [Pg.372]    [Pg.456]    [Pg.2]    [Pg.6]    [Pg.6]    [Pg.142]    [Pg.153]    [Pg.153]    [Pg.180]    [Pg.184]    [Pg.184]    [Pg.211]    [Pg.347]    [Pg.356]    [Pg.404]   
See also in sourсe #XX -- [ Pg.166 ]

See also in sourсe #XX -- [ Pg.4 , Pg.179 ]

See also in sourсe #XX -- [ Pg.9 , Pg.62 ]




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Aseptic

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Aseptic fill products, process flow

Aseptic filling batch manufacture

Aseptic filling broth fill contamination

Aseptic filling definition

Aseptic filling processing capability

Aseptic filling room

Aseptic filling sterility confidence level

Aseptic filling validation

Aseptic filling, qualification

Blow-fill-seal aseptic processing

Blow-fill-seal aseptic processing container

Process Flow, Variables, and Responses Aseptic Fill Products

Sterility assurance aseptic filling process

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