Dyes, antioxidants agents, toxic inorganic substances are a few examples of contaminants that can enter into a finished drug. These contaminants might enter into the medicinal product through machinery employed or materials used for the production. It can also enter through the packaging materials. These contaminants can be called extractable and leachable substances.
Extractable are compounds that are extracted from a component material (materials used for production or delivery) into the medicinal product. While leachable are compounds that leach themselves into the medicinal product through the packaging materials, closure system, or manufacturing processes. Both substances are dangerous and can have an adverse effect on the biological product. As a result, many manufacturers ensure that they follow strict procedures that will make a product free from contamination.
A good contract manufacturer will conduct extractable and leachable evaluations on each batch of drugs produced. This is to ensure that pharmaceutical firms release drugs that wouldn’t harm others. So if you own a pharmaceutical company, make sure that the manufacturer you hire follows a strategy that won’t expose your products to contamination.
Having knowledge on how a drug can be at risk of exposure to extractable and leachable substances is vital. It is also necessary to know how to avoid these compounds. In that vein, let us discuss what can cause each of the contamination and how to avoid it.
Causes of Extractable Substances
Extractable is generated by the reaction of drugs with their packaging after a long period. These substances can be present through artificial means. Under harsh temperature, solvent, and time conditions, the contaminants are formed when they interact with a closure system. The compounds can be additives added to the closure material to modify its polymeric properties. It might also be by-products of the polymeric substance like a residual catalyst, unreacted monomers, degradants, or processing aids.
Extractable is extracted into a drug by solid to liquid or solid to gas interface. This interaction relies on the solubility of the substance in the medicinal product, the temperature, and the pressure of the closure material.
Causes of Leachable Substances
Leachable are a subset of extractable that are present due to the steps in manufacturing procedures. Leachable can also be chemicals from both primary and secondary packaging. These have the potential to enter into a finished medicinal product without being extracted by harsh conditions, like the extractable.
The primary packaging materials are those that have direct contact with the finished drug product or have the potential to come in direct contact with it. These include the bottle, ampule, or vial. They can even include the closure lines, the bottle caps and seals, and the metering valves.
Secondary packaging materials are related to the final marketing package. They are not in close contact with the drugs but still, they can leach into the product and pose risks. Some of these secondary packaging include cartons, shipping containers, administration accessories, and container labels.
How to Prevent Extractable and Leachable Contamination of Pharmaceutical Drugs
Now that you have known how these substances enter into medicinal products, it is vital to know how to prevent and evaluate these substances. Here are some ways to accomplish this:
Managing Production Personnel
The first line of contamination is from the personnel handling the production processes. This workforce must be highly qualified in handling the procedures. They should also be professionally trained in maintaining cleanliness and hygiene. They should always wear protective gear and avoid touching the products with their bare hands.
There must be a set rule in place to regulate how they behave in the production unit. There mustn’t be eating or drinking in the production unit and workers should be mandated to wash their hands before touching any material. These rules can be called general manufacturing practices. To read more about these rules and how to adopt them in the pharmaceutical industry, you can check here:https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps
Disinfect Machinery Regularly
Regular sanitizing and cleaning of the machines used during manufacturing is necessary. Apart from thoroughly disinfecting and cleaning them, the hygiene and cleanliness of work wear are vital too.
Regulate Water Source
Some contaminants can come from water sources. If the manufacturers use a poor source of water in production, you cannot expect great quality from the end-product. So ensure that the organization only uses distilled water during the manufacturing process.
The facility must be compliant with regulatory standards. It must not be humid and its temperature must be optimized. Some contaminants like extractable can be worsened with harsh conditions. The right facility will reduce the risk of these substances.
Conducting Tests on Products
Before bringing a drug to the market, it is necessary for it to undergo extractable and leachable testing (E&L testing). This testing is to ensure that the medicinal drug does not contain any of these compounds. It is also important to conduct this test on the package or closure to use on the drugs. This ensures that you choose the right package for the drugs.
Methods employed for this testing must be related to the contaminants. There are various analytical testing to follow. They include IR spectrometry, liquid chromatography-mass spectrometry (LC-MS), and inductively coupled plasma (ICP). A good manufacturer will make sure that their drugs undergo each of the tests before releasing them to consumers. If you would like to know how these tests are conducted, you can read this article.
Contaminants like extractable and leachable pose risks to the health of drug consumers. They can also damage the reputation of the pharmaceutical industry. Identifying the causes of these issues and taking the necessary steps to prevent them can help to maintain the premium standards of a company and its compliance with regulations.
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