Heavy Metal Testing in Pharmaceuticals is a Must
Heavy metal toxicity poses a real and serious threat to consumer safety in the pharmaceutical industry. Using a professional-grade pharmaceutical metal detector as part of your quality control operations can help greatly reduce the likelihood of contamination and prevent compromised products from reaching pharmacy shelves.
Today, we are going to discuss the importance of metal contamination prevention and cover some essential facts about pharmaceutical metal detectors. Let’s start with how heavy metals can compromise a product’s integrity.
How Do Heavy Metals Get into Pharmaceutical Products?
Heavy metals enter into pharmaceutical products through three primary causes: Deliberate additives, residue from production equipment, and impurities in source ingredients.
Deliberately Adding Metals to Formulas
Some metals are added to pharmaceutical formulas to serve as an active ingredient. For example, an iron supplement does purposely contain metal, as it is an essential nutrient for the body. However, with approved metal supplements like these, they are added in industry-regulated amounts.
Residue from Production Equipment
Metal residue from your pharmaceutical manufacturing equipment mixing in with your product is a natural phenomenon that can happen at any time. This can stem from a variety of factors like rust, heat, and friction that might cause pieces of the machinery to break off into the mixture it is processing.
How can one prevent this from happening? While there is no way to completely eliminate the likelihood of this occurring at some point in time, there are a few steps that you can take to ensure that frequency is limited as much as possible. These include:
- Using high-quality production equipment
- Regularly and thoroughly cleaning your machinery and system components
- Inspecting your equipment at the start and end of the workday for any signs of damage
- Identifying and treating rusted portions of your equipment
- Replacing pieces of equipment that have cracked or rusted beyond repair
- Using pharmaceutical metal detectors in your quality control process
- Having your equipment serviced by professionals on a regular basis
Source Ingredient Impurities
Both refined and unrefined source ingredients may contain natural impurities within them, including various metals. While a refining process will attempt to rid as many impurities as possible, contaminants might still persist.
What Are the Effects of Heavy Metal Contamination?
Heavy metal toxicity can cause severely painful symptoms in the human body. In some severe cases, this can also lead to a person’s death. Heavy metals like arsenic are notoriously lethal to consume even in small doses.
Heavy metal poisoning’s life-threatening potential should never be underestimated. It is the responsibility of pharmaceutical companies to implement extensive quality control practices to prevent metal-contaminated products from reaching store shelves as much as humanly possible and to quickly recall any that might have been accidentally shipped to retailers.
If a pharmaceutical brand does not take steps to mitigate the damage of unintentional heavy metal contamination in their products, this can open up vulnerability to future legal action. This reality reminds us once again why quality control remains of the utmost importance.
Heavy Metals to Look Out For During Quality Control
The National Organization for Rare Diseases identifies the following heavy metals as ones to monitor for:
A-L: Aluminum, antimony, arsenic, barium, bismuth, cadmium, chromium, cobalt, copper, gold, iron, led, and lithium.
M-Z: Manganese, mercury, nickel, phosphorus, platinum, selenium, silver, thallium, tin, and zinc.
What is an Acceptable Limit for Heavy Metals in Pharmaceuticals?
The acceptable thresholds for the presence of heavy metals in pharmaceuticals varies by the type of metal, medium of consumption, and its concentration within a product formula. Refer here for the full list of USP elemental impurity limits for heavy metals.
How Do You Know if Your Pharmaceuticals are Contaminated by Heavy Metals?
Unfortunately, the human eye cannot detect heavy metal contamination. Instead, using a pharmaceutical metal detector is the best way to assure a product’s quality and safety. These metal detectors can be purchased in many different sizes to handle quality control processes at varying unit quantities. Most often, these devices are constructed in a tabletop or cart form.
How Do Pharmaceutical Metal Detectors Work?
Depending on the manufacturer, a pharmaceutical metal detector may function differently from one designed by a competing brand. However, most operate in a similar fashion to these steps here:
- Capsules, pills, softgels, or gummies are loaded into a funnel at the top of the machine
- The metal detector rapidly moves units through a small passage with a cowbell-shaped swivel at the bottom
- If impurities are detected by the metal detector, the swivel moves rapidly removes the rejected units into a separate container for future disposal
Most metal detectors also allow the operator to adjust various settings to account for regulation limits, detecting ferrous or non-ferrous metals, and other similar concerns.
Get a Pharmaceutical Metal Detector for Your Production Facility Today
At CapPlus, we share the same commitment to product integrity and consumer safety that you do at your production facility. Our mission is to connect pharmaceutical manufacturers with leading packaging, production, and quality control equipment that perfectly aligns with their needs. To learn more about our current lineup of pharmaceutical metal detectors, contact us anytime.