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As the nitrosamine scandal continues, we explore the advancements in parenteral packaging materials that are reducing the risk of this contaminant in modern injectables.
The glass used to package, store, and deliver drugs today was created in 1881 — just 16 years after the Civil War ended — and has changed very little since then, and it’s these vials that drug companies, who are creating ever-evolving, more complex drugs, are beholden to use.
MIT engineers have designed a food sensor , made from an array of silk microneedles, that can pierce through the plastic packaging of foods to sample for bacterial contamination and spoilage. The Velco-like device pierces the packaging and the food via silk microneedles that suck in material through capillary action.
Manufacturers are actively looking at ways they can improve drug delivery through well-designed parenteral packaging systems, and the choice to deploy prefilled syringes for more and more injectable drug products is a key part of this push. Prefilled syringes offer a number of advantages over the more traditional glass vial.
Compared to other dosage forms, tablets are simpler to manufacture, package, and transport. This heightens the risk of cross contamination, requiring effective containment solutions, especially when handling highly potent powders. As with any pharmaceutical manufacturing, challenges can be many, and processes are highly regulated.
Datwyler is a leading provider of parenteral packaging components and is helping the industry put quality first through the invention of the FirstLine® manufacturing standard. This whitepaper discusses the issue of nitrosamine contamination since 2018 and the response from regulators and industry.
The US Food and Drug Administration (FDA) announced a voluntary phase-out of certain types of grease-proofing agents on paper and paperboard food packaging. These chemicals help prevent grease and oil from seeping through the packaging. Why PFAS in Food Packaging Is a Problem. Yet PFAS are finding their way into our bodies.
These days, it’s hard to find food, especially processed food, that isn’t encased in some form of packaging. Modern food packaging has allowed for safer, cleaner, more reliable, shelf-stable food – but at what cost? Discarded food, and the packaging it comes in, accounts for nearly 45 percent of waste in US landfills.
At the same time, Purdue University introduced a paperbased, loopmediated isothermal amplification biosensor that detects fecal contamination in produce fields in under an hour. While in Europe, TraceOne and Citeo launched an automated recyclabilityscoring integration for packaging with seven French brands in pilot.
A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. They provide specific guidance on packaging requirements for closed closure integrity (CCI) and general integrity testing. Container Closure Systems. Container closure systems are highly regulated by health agencies.
Rather, they are specific packages of the “Gummies” variety of these products. Since metal contamination is a common issue in food production, resulting in expensive recalls and lawsuits, the FDA has implemented metal detection standards to ensure the same principles are followed for all companies. And any foreign object less than 0.3
Aluminum is a popular choice for food packaging because of its superior recyclability and unique properties for product brands over other materials like plastics and glass – it is endlessly recyclable compared to plastic and paper, while being lighter and studier than glass. Availability. Environmental Sustainability. Versatility.
AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. According to AvKARE, the error occurred at a third-party bottle filling facility.
There are a variety of materials that are used for food packaging, and they serve some very important functions in the food industry. Many of the foods purchased by consumers today are contained in packaging made from materials such as paper, plastic, metal or glass. One of the hallmarks of food packaging is the single-use design.
Packaging plays a critical role in the pharmaceutical industry, ensuring that medications remain safe, effective, and stable throughout their shelf life. At Tjoapack, we are your trusted provider of pharmaceutical packaging services , dedicated to maintaining the integrity and efficacy of your products from production to patient use.
I'm talking about Good Manufacturing Practice (GMP), a set of guidelines that govern the production, testing, and packaging of generic drugs. GMP is more than just a regulatory requirement; it's a mindset that prioritizes patient safety and product quality above all else.
Medical device packaging plays a key role in ensuring the safety, efficacy, and integrity of medical devices from the point of manufacture to the end-user. At Tjoapack, we are a premier provider of top-tier medical device packaging services. The packaging must adhere to guidelines set by authorities such as the FDA and EU GMP.
In the context of generic drugs, QA involves a range of activities, including: Conducting regular audits and inspections of manufacturing facilities to ensure compliance with regulatory requirements Testing finished products for purity, potency, and stability Verifying the accuracy of labeling and packaging Monitoring the supply chain to prevent contamination (..)
That’s why the drug packaging process is so important, and must be carried out correctly. Primary packaging is the first step in the drug packaging process. Packing materials that come in direct contact with pharmaceutical products—such as blister packs, bottles, vials, and ampules—are all examples of primary packaging.
Medical device packaging plays a vital role in the public health sector, ensuring that medical devices make it to consumers without being damaged or compromised. With such an important job to do, medical device packaging must meet several strict requirements. We look forward to assisting with all of your packaging needs.
From packaging errors and contaminants to serious adverse effects, there are many reasons why products in the life sciences industry get recalled. Here’s a look at some of the latest drug and medical device recalls.
AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. According to AvKARE, the error occurred at a third-party bottle filling facility.
Related: FDA Announces Slow Phase-Out of Certain PFAS Chemicals Used in Food Packaging. Sprouts can carry a risk of foodborne illness if they are contaminated, and unlike other fresh produce, the warm, moist conditions required to grow sprouts are ideal for the rapid growth of bacteria, including Salmonella , Listeria , and E.
Both the Minute Maid and Coca-Cola beverages are set to expire in 2022, which means consumers might still have products that contain the unspecified contaminants. coli , listeria or salmonella contamination in raw produce and meat, this is not the first beverage-related recall this year. While recalls tend to address E.
The Rethink Plastic alliance, in collaboration with a coalition of 81 organizations, is advocating for the integration of effective reuse systems into the European Union’s (EU’s) Packaging and Packaging Waste Regulation. This push aims to mitigate waste produced by single-use plastic takeaway packaging.
These tiny particles, primarily from environmental contamination, can infiltrate the food supply. Plastics are ubiquitous in consumer and industrial products, ranging from packaging to automotive parts. Microplastics and nanoplastics primarily contaminate food through environmental exposure where crops and livestock are raised.
Data has long been incorporated into drug packaging to accomplish these goals, but only to a partial degree with embossed lot numbers, expiry dates and even Braille identification in addition to linear bar codes. For example, Turkey will require track and trace by 1 January 2009 and California is requiring the technology by 1 January 2011.
Considering patient’s health and safety, the drug products are expected to be free from microbial contamination and should be safe for use throughout the drug’s life cycle. One of the stages that require quality assurance is packaging of the drug product, as compromised packaging could have serious consequences.
Cleanrooms are critical in the development of pharmaceuticals, offering a controlled environment free from contamination to test new drugs and therapeutic devices. Each room is developed to deliver a specific environment to unique ISO standards to avoid contamination. But with a single dedicated cleanroom environment costing around $2.5
These tiny particles, primarily from environmental contamination, can infiltrate the food supply. In this episode of the Xtalks Food Podcast, Sydney talks about how microplastics and nanoplastics primarily contaminate food through environmental exposure where crops and livestock are raised.
The US Food and Drug Administration (FDA) estimates that nearly 48 million people are sickened by food contaminated with harmful germs each year, with produce being the culprit in many cases. Proper produce washing methods may not be pressing to most outside of professional kitchens, but the PD100 is making the case that it should be.
In order to reduce the amount of packaging waste, the zero-waste trend (bying food in bulk) has recently developed. Sciensano, as a center of excellence in evaluating potential risks of known and emerging contaminants in food contact materials ( FCM ), designed a survey to address this gap. But is this trend safe?
Under SB 343, a product or packaging is not recyclable in California if: It includes components, inks, dyes, adhesives, or labels that prevent its recyclability; It contains intentionally added chemicals identified pursuant to regulations implementing section 42370.2(g)(4) g)(4) of the California Public Resources Code; or.
MenuTrinfo’s certification scheme covers an exhaustive list of over 100 manufacturing points for a consumer packaged goods (CPG) brand to earn the seal for their products. Mitigating Cross-Contamination with MenuTrinfo One of the most pertinent concerns for anyone with allergies is the potential for cross-contamination.
It also found detectible levels of phthalates in food handling gloves, which researchers said could be a source of contamination. Related: FDA Announces Slow Phase-Out of Certain PFAS Chemicals Used in Food Packaging. What are Phthalates?
Raw flour is prone to contamination in the field by birds and animals as well as during harvest, transportation and processing. Flour doesn’t seem like a raw food, but most bagged flour that can be purchased from the grocery store is actually raw, meaning that it hasn’t been treated to kill the germs that cause food poisoning.
Why Cinnamon is Prone to Higher Lead Levels Cinnamon can become contaminated with lead through various pathways. One primary source is environmental contamination. Additionally, the processing of cinnamon, including drying, grinding and packaging, can introduce lead if the equipment or materials are contaminated.
XTALKS WEBINAR: Drug Delivery — Addressing Global Regulatory Challenges in Co-Packaged, On-Body Systems Live and On-Demand: Thursday, June 15, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn about on-body drug delivery systems and addressing their complex global regulatory requirements.
Secondary drying removes adsorbed residual moisture until the target value is achieved, at which point the material is secured in a moisture-free package. Protecting products from microbial contamination is also critical, especially when it comes to aseptic freeze drying of pharmaceuticals.
Approximately one in every 25 chicken packages at grocery stores is contaminated with Salmonella. The Centers for Disease Control and Prevention (CDC) estimates that Salmonella is the leading cause of foodborne illnesses, with chicken being a significant contributor.
The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. Bioburden and microbial testing. an antibiotic).
Requirements relating to biologics’ starting and auxiliary materials, controlling the contamination of biologics, and biologics’ storage and transportation requirements would be replaced with more flexible conditions which apply more broadly. Manufacturing Controls. On-site Evaluations.
Relevant software packages may offer you options to track down a sample by project, origin, date of collection (or use), to name just a few options. If you find out a sample was contaminated at the source, you can alert all relevant personnel within a matter of seconds before confirming they all received the alert in person.
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