Sterilization injectable products

Antimicrobial preservatives are added to multiuse nonsterile liquids, ointments, and ereams, and sterile injectable products to protect them from microbial contamination that may be introduced inadvertently during use of the product (postmanufacturing). 

This can be used as an alternative to routine release testing of the drug product. The most common example is sterility testing of terminally sterilized injectable products, whereby the release of a batch is based on monitoring certain parameters during the manufacturing cycle, such as temperature and pressure. 

The plant is designed to produce oral solid dosage forms as well as liquid dosage forms, ointments, creams, suppositories, and sterile injectable products. 

FDA recommendations have advised limits for ophthalmic and sterile injectable products. These limits include ethylene glycol from the hydrolysis of ethylene oxide and epichlorhydrin which results from the interaction of chloride ions with ethylene oxide. Flowever, significantly lower levels are currently being advised, i.e. down to 2 ppm in Europe. 

Small Volume Parenteral A sterile injectable product intended for administration under or through the skin with a nominal fill volume of 100 mi or less. It may be packaged in glass or suitable plastic material. 

As the innovation literature has pointed out since the work of Von Hippel, firms also learn from the users of their products (Von Hippel, 1982). Some producers have stressed the importance of the feedback collected by their marketing teams. A firm selling sterile injectable products stated that important knowledge was learned from nurses who used their products, and changes were implemented following the nurses feedback. 

The first official injection (morphine) appeared in the British Pharmacopoeia (BP) of 1867. It was not until 1898 when cocaine was added to the BP that sterilization was attempted. In this country, the first official injections may be found in the National Formulary (NF), published in 1926. Monographs were included for seven sterile glass-sealed ampoules. The NF and the United States Pharmacopeia (USP) published chapters on sterilization as early as 1916, but no monographs for ampoules appeared in USP until 1942. The current USP contains monographs for over 500 injectable products [1]. 

It has been only in the past 25 years that filters have become sufficiently reliable to use them on a wide scale to sterilize injectable solutions. Even now it is prudent to use filtration to sterilize only those products that cannot be terminally sterilized. 

Sterility, freedom from pyrogens, and acceptably low level of extraneous particulate matter are critical quality attributes of all injectable products. Additional critical quality attributes depend on the clinical use of the product. For example, for IV, IM, and SC routes, isotonicity and physiological pH (7.4) are always desirable in order to minimize potential irritation upon injection. Other factors may preclude this, however. If the required dose of drug must be administered in a small volume, it may not be feasible to formulate an isotonic solution. Likewise, solubility or stability considerations may preclude formulation at physiological pH. This explains why formulation pH for injectable drugs varies from about pH 2 to about pH 11. 

Class II recalls are those in which the use of or exposure to a product found in violation of the law may cause a temporary health problem that is reversible, or in which the situation would not cause serious adverse health consequences. Examples of this type of recall would include uncertainty of the sterility of an injectable product, Salmonella contamination of various types of oral dosage forms, inadequate directions for use, and improper buffering of solution for injection [20]. 

Dosage form Ceredase is a sterile solution for injection, supplied in 5ml bottles containing alglucerase 80 units/ml. Cerezyme is supplied as a sterile lyophilized product for injection. Each vial contains imiglucerase 212 or 424 units. Amost all patients with Gaucher s disease use Cerezyme for enzyme replacement therapy. Ceredase is only available in limited supplies for the treatment of patients who do not tolerate Cerezyme. 

Category I la. Injections, other parenterals including emulsions, otic, sterile nasal products, and ophthalmic products made with aqueous bases or vehicles... 

This is not an anabolic steroid nor is it even an anabolic chemical except as a food. These were reported popular injectable products that contain a sterile (bacteria free and pure) medium chain triglyceride (MCT), an acid, and usually Procain or lidocaine (all of which have been made inert). The oil was injected deep into a muscle to add size. Usually this was done to smaller muscle groups such as biceps, triceps, delts, calves, and smaller round back muscles. 

Synthol has become popular site-injection product both for chemically assisted and natural bodybuilders as of late. This is actually an illegal practice in many countries so the products are sold as topical "posing oils". The products contain an inert MCT oil which has been put through a series of processes to create a sterile product. Sometime back I was introduced to another but far more effective topical posing oil from a gray market supplement company called Hazardous Materials located in California. 

Sterile Injectable Pellet Implant Solution or Ointment for Ophthalmic Administration Inhalation Products Oral Dosage Forms... 

Most freeze-dried pharmaceuticals—and, of course, all injectable products—need to be sterile. Until now, the usual rule to achieve that goal has been to start with a sterile solution and, from there on, to carry out an entirely sterile process. Indeed, the time is over when the manufacturers could add a 1/10,000 merthiolate to get rid of an accidental contamination. Today all freeze-dryers have their cabinets opening within a sterile room while the machinery is sitting behind the wall in the engine room. Moreover, the drying chambers are all equipped with clean-in-place (CIP) systems and can be sterilized by pressure steam before each operation. Finally, those products that are prepared in vials are sealed directly within the chamber thanks to moving pressure plates that drive the stoppers tight into the neck of the vials. 

The most widely used solvent for SVIs is water for injection (WFI), USP. As a solvent, WFI is used in preparing the bulk solution (compounding) and as a final rinse for equipment and packaging preparation. WFI is prepared by distillation or reverse osmosis, although only distillation is permitted for sterile water for injection, USP. Sterile water for injection is used as a vehicle for reconstitution of sterile solid products... 

This chapter is a comprehensive review of the excipients included in the injectable products marketed in the United States, Europe, and Japan. A review of the literature indicates that only a few articles that specifically deal with the selection of parenteral excipients have been published. However, excipients included in other sterile dosage forms not administered paren-terally, such as solutions for irrigation, ophthalmic or otic drops, and ointments, will not be covered. 

Water used in manufacture of sterile parenteral products must comply with pharmacopeial limits for endotoxin of no more than 0.25EU/ml (limits in the USP and PhEur for water for injection). In principle water complying with this limit can be produced by... 

Injectable products, ophthalmic products, and inhalation solutions Pharmaceutical ingredients Purified water Manufacturing environment Products As above Loop and taps daily Every shift in critical aseptic processing areas Every batch with the exception of terminally sterilized products approved for parametric release... 

Sterile aqueous solutions prepared with high purity ascorbic acid and pyrogen-free distilled water in glass-lined equipment under absolute sanitary operations and filled into ampules are necessary for injectable solutions for parenteral use in humans and animals. For all injectable products, it is important to select container, stopper, preservative, and other ingredients that are compatible. 

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