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Equipment used in aseptic processing of food and beverages must be sterilized before processing and remain sterile during processing. [1] When designing aseptic processing equipment there are six basic requirements to consider: the equipment must have the capability of being cleaned thoroughly, it must be able to be sterilized with steam, chemicals, or high-temperature water, sterilization ...
So SAL is used to express the probability of the survival. For example, medical device manufacturers design their sterilization processes for an extremely low SAL, such as 10 −6, which is a 1 in 1,000,000 chance of a non-sterile unit. SAL also describes the killing efficacy of a sterilization process.
BFS-packaged eye drops for single use. Blow-Fill-Seal, also spelled as Blow/Fill/Seal, in this article abbreviated as BFS, is an automated manufacturing process by which plastic containers, such as bottles or ampoules are, in a continuous operation, blow-formed, filled, and sealed.
These are specifically designed for non-medical applications. Research autoclaves often use a “jacketless” design where steam is generated directly in the pressure chamber using heating coils (rather than relying on a “steam jacket” and independent steam generator, as is the case in high-throughput medical autoclaves).
Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations , such as milling , granulation , coating , tablet pressing , and others.
Direct systems have the advantage that the product is held at a high temperature for a shorter period of time, thereby reducing the thermal damage for sensitive products such as milk. There are two groups of direct systems: [15] Injection-based, where the high-pressure steam is injected into the liquid.
A form-fill-seal process means that the blister pack is created from rolls of flat sheet or film, filled with the pharmaceutical product and closed (sealed) on the same equipment. Such equipment is called a blisterline. There are two types of blister machine' design: rotary and flat-plate, depending on the mechanism for sealing the lidding foil.
Grand River Aseptic Manufacturing (GRAM) is a clinical and commercial sterile manufacturing contractor to the pharmaceutical industry. It has lyophilization , terminal sterilization, analytical, microbiological testing services.