Pharmaceutical industry sterile products

Pharmaceutical Industry. In the pharmaceutical industry, sterility of deionized water systems is maintained by using an ozone residual. The ozone residual concentration is maintained at >0.3 ppm ppm in the water recirculation loop. Prior to product compounding, the ozone residual is removed by contact with uvirradiaton for <1 s. Ozone also is used to oxidize pyrogens from distilled water destined for intravenous solutions. [Pg.502]

Process constraints may be different for the pharmaceutical and food industries, as well as for the above types of product. It follows that a process modification can be beneficial or applicable only to specific material types or equipment. For example, in the pharmaceutical industry sterility is often a predominant requirement, while minor attention is given to energy efficiency. Therefore, a new technology that enhances heat and mass transfer, but compromises sterflity conditions, is not suitable for the drying of drugs. [Pg.164]

This procedure provides the information required to support the sterility assurance of the drug product (product name), USP, manufactured by ABC Pharmaceutical Industries. It references the FDA Guidance titled Guidance for Industry for the Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Dmg Products prepared by the Sterility Technical Committee of the Chemistry Manufacturing Controls Coordinating Committee of the Center for Dmg Evaluation and Research (CDER) and the Center for Veterinary Medicine (CVM) in November of 1994. [Pg.478]

The required information as outlined in sections IV and V of the EDA Guidance is in boldface type, followed by ABC Pharmaceutical Industries information. It is submitted in the ANDA file for the manufacturing of (product name) USP. Other sections of the Guidance (sections I to III) pertain to the Guidance s introduction and terminal sterilization processes. [Pg.478]

This document contains information related to the liquid aseptic fill operation used in the manufacture of (product name), USP, at ABC Pharmaceutical Industries located at (provide postal address). Additional information to support the liquid aseptic filling validation includes but is not limited to environmental monitoring and controls, as well as product-specific testing such as bioburden and sterility testing. The main subsections are ... [Pg.478]

ABC Pharmaceutical Industries is located (provide postal address). ABC Pharmaceutical Industries manufactures sterile pharmaceutical dosage forms in strict compliance to the cGMP, United States FDA guidelines. ABC Pharmaceutical Industries is supplying its products to its customers around the world. [Pg.478]

The stoppers are sterilized in a validated component sterilizer and unloaded into the sterile storage area (level II, controlled access class 100) until needed for production. Supplier (provide name) ships rubber stoppers to ABC Pharmaceutical Industries in auto-clavable bags. [Pg.497]

ABC Pharmaceutical Industries information. The equipment preparation pages of the master batch record specify the validated sterilization processes to be employed in the preparation of the equipment for (product name) USP. Cycle sterilization parameters are defined along with attributes such as loading patterns and the mechanics of operating the sterilizing equipment. The following lists the sterilization cycles utilized for the equipment required in the processing of (provide product name) USP ... [Pg.513]

ABC Pharmaceutical Industries routinely monitors the microbial content of the air, inanimate surfaces, personnel, water systems, and product component bioburden. Microbiological monitoring of these areas generally reflects on the efficiency of cleaning and sanitization procedures and employee practices. Continuous environmental monitoring provides the assurance that product is produced by a controlled process that will maximize the sterility and quality of the manufactured sterile product. [Pg.520]

The fact that the pharmaceutical industry indulges in the separate sterilization of products and containers has previously been mentioned (Sec. IVGlc). Three general applications of radiation sterilization therefore exist radiation of (1) the product, (2) the containers, or (3) the product in the container. The first possibility has been discussed the others deserve elaboration. [Pg.414]

How the product will be used by the patient or the customer—Here again our industry is so diverse that we must indicate that the limits calculated should take into account the nature of the customer. Is the customer another company that uses the product, which may be a chemical, to make another intermediate, or is the customer the patient who actually takes the product in the form of a finished pharmaceutical dosage form Is the product a sterile product and do we need to consider bacteria as a potential contaminant or is the product a nonsterile product in which bacterial contamination may be a lesser issue If the product is a finished pharmaceutical dosage form, will it be used intravenously, orally, ophthalmically, topically, rectally, vaginally, or by other means ... [Pg.525]

Another professional organization headquartered in central Europe, APV (International Association for Pharmaceutical Technology, Mainz, Germany), developed the topic further in two seminars in Gelsenkirchen in late 1981 and early 1982 [6]. Speakers from industry demonstrated how validation could be applied to industrial activities and how a balance between resources allocation and results could be achieved. Oral dosage forms, topicals, and sterile products, as well as analytical methods during development, transfer, and production phases were discussed. [Pg.854]

Such freezing processes are more suitable for a production of foods and clean operations than for use in the pharmaceutical industry. It is extremely difficult to attain sterile conditions. [Pg.172]

The primary market for the disposable cartridge is sterile filtration for the pharmaceutical industry and final point-of-use polishing of ultrapure water for the microelectronics industry. Both industries require very high-quality, particle-free water. The cost of microfiltration compared to the value of the products is small so these markets have driven the microfiltration industry for the past 15 years. [Pg.296]

Microfiltration is used widely in the pharmaceutical industry to produce injectable drug solutions. Regulating agencies require rigid adherence to standard preparation procedures to ensure a consistent, safe, sterile product. Microfiltration removes particles but, more importantly, all viable bacteria, so a 0.22- xm-rated filter is usually used. Because the cost of validating membrane suppliers is substantial, users usually develop long-term relationships with individual suppliers. [Pg.296]

The irradiation of micellar solutions effects the phase behavior and the critical micelle concentration (CMC). Because radiation sterilization of biopharmaceutical products is a common routine it is important to investigate the influence of radiation on surfactants that are widely used in the pharmaceutical industry for formulations as wetting agents, emulsifiers, or solubilizers. In particular, in drug formulations... [Pg.115]

The science that underpins steam sterilization is well known and has been long established. It is the preferred method of sterilization in the pharmaceutical industry it is used for sterilization of aqueous products in a wide variety of presentations, for sterilization of equipment and porous materials required in aseptic manufacture, in microbiology laboratories for sterilizing media and other materials, and for sterilization of massive systems of vessels and pipework [steam-in-place (SIP) systems]. Numerous rules and guidelines have been published on the topic, yet steam sterilization and particularly bio-validation of steam sterilization is still a subject for controversy and debate. [Pg.325]

Although gelatin has been used by the pharmaceutical industry for mainly producing soft and hard gelatin capsules, some commercial products use a hydrated gel form. The sterile product, H.P. Acthar Gel (Rorer),... [Pg.1883]

At present, the pharmaceutical industry regulatory requirements refer to isolators specifically in the context of the manufacture of sterile products. There is no reference to their role in broader areas of crosscontamination and operator safety control. Within Europe, the current EU GMP clearly states that isolators might produce improvements in sterility assurance of sterile products, and that aseptic processing manufacturing isolators should be placed in at least a Grade D surrounding environment. The Food and Drug Administration (FDA) requirements are less well defined, but it is likely that in equivalent circumstances, they would like to see an isolator located in a class 100,000 or M6.5 environment In Operation. ... [Pg.2134]

Products made in the pharmaceutical industry today must meet high microbiological specifications, i.e. if not sterile, they are expected to have no more than a minimal microbial population at the time of product release. [Pg.263]

Membrane-based separation processes are recognized as environmentally friendly alternatives to conventional separation techniques such as distillation or extraction. The field of large-scale applications covers the range of drinking water processing, potable water production, waste-water treatment, application in the food and pharmaceutical industries, recovery of aroma and active substances as well as sterile filtration of pharmaceuticals and clarification of beverages. [Pg.282]

Ultrafiltration processes are used to recover or concentrate a particular species in the retentate, as is exemplified by latex concentration, or to obtain a purified permeate as in sewage treatment. Ultrafiltration is a means of cold sterilization for many heat-sensitive liquids whose sterilization could not be carried out earlier. Thus, in the food industry draft beer provides an interesting example of a product whose feasibility as a commercial beverage has been an outcome of ultrafiltration cold sterilization by ultrafiltration retains the esters on account of which the beer has its draft flavour. Similarly, ultrafiltration plays a key role in the pharmaceutical industry for the commercial-scale preparation of sterile water and antibiotics. [Pg.390]

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