STAT News

AUGUST 15, 2022

communities. Although researchers have known about the impact of these chemicals for years, there has been little guidance available for clinicians.

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Pharma Packaging Solutions

AUGUST 3, 2023

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.

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Packaging Packaging Pharma Packaging Contamination 52

XTalks

MAY 3, 2024

Approximately one in every 25 chicken packages at grocery stores is contaminated with Salmonella. Other food products can also be contaminated with Salmonella. For example, last month, Trader Joe’s recalled specific fresh basil packages from 29 states following a Salmonella outbreak that affected 12 individuals.

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XTalks

DECEMBER 14, 2020

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.

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XTalks

SEPTEMBER 17, 2020

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.

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Production Contamination Cosmetics Bacteria 98

XTalks

MAY 18, 2023

Cornell University researchers have been making strides in the development of a revolutionary tool to combat dangerous pathogens in commercial dry food manufacturing plants. Food manufacturers use steam for tasks like dehydration, distillation, pasteurization and cooking, which helps preserve the taste and texture of their offerings.

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Manufacturing Contamination Production Packaging 52

XTalks

DECEMBER 20, 2021

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.

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Contamination Containment Production Packaging 98

XTalks

AUGUST 25, 2023

These certifications are often sought by food manufacturers to assure consumers about the safety of their products for those with food allergies, intolerances and special dietary requirements. Mitigating Cross-Contamination with MenuTrinfo One of the most pertinent concerns for anyone with allergies is the potential for cross-contamination.

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Roots Analysis

APRIL 15, 2024

Further, the manufacturing of biologics fill finish is a highly complex and cost-intensive process. Notable examples of fill finish manufacturing companies equipped with SA25 aseptic filling workstation include ( in alphabetical order ) Emergent Bioservices, PCI Pharma Services, Singota Solutions and WuXi Biologics.

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Roots Analysis

FEBRUARY 28, 2022

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. Web: [link].

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Pharmaceutical Technology

DECEMBER 13, 2022

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.

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Production Contamination Manufacturing Packaging 130

XTalks

AUGUST 15, 2024

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.

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The Pharma Data

DECEMBER 30, 2020

Made in China, the recalled products are packaged in a white opaque or clear plastic bottle with either a blue, clear, or black cap and are labeled as IMC Wash-Free Hand Sanitizer, Wash-Free Hand Sanitizer, and Thrifty White Pharmacy Hand Sanitizer. ” The recall covers 4-ounce and 1-pint (16-ounce) bottles, NDC Nos.

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Contamination Containment Production Bacteria 52

XTalks

APRIL 11, 2024

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.

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Contamination Branding Production Containment 59

The Pharma Data

DECEMBER 30, 2020

Made in China, the recalled products are packaged in a white opaque or clear plastic bottle with either a blue, clear or black cap and are labeled as IMC Wash Free Hand Sanitizer, Wash Free Hand Sanitizer and Thrifty White Pharmacy Hand Sanitizer, CBS News reported.

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FDA Law Blog

NOVEMBER 22, 2022

coli contamination. On November 15, as part of the Agency’s implementation of the Food Safety and Modernization Act (FSMA), FDA released the f ood traceability final rule , which aims to reduce the occurrence of foodborne illnesses by enabling FDA to more efficiently identify and remove potentially contaminated food from the market.

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The Pharma Data

NOVEMBER 4, 2020

” Type 2 Diabetes Drug Metformin Recalled Due to Contamination with Carcinogen. NDMA is an organic chemical used in the making of liquid rocket fuel and can be a byproduct of manufacturing, including pharmaceuticals. This is the latest in several recalls of metformin due to potentially cancer-causing contaminants, CNN noted.

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Contamination Drugs Packaging Packaging 52

Roots Analysis

JANUARY 17, 2024

They offer several advantages over traditional drug delivery systems ( such as vials and syringes ), including reduced chances of dosing errors, increased patient compliance and decreased risk of microbial contamination. These syringes also have low risk in supply chain and streamlined regulatory process ( when compared to other materials ).

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Drug Delivery Contamination Drugs Production 40

XTalks

MAY 13, 2022

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.

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Packaging Packaging Containment Production 98

XTalks

OCTOBER 26, 2020

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.

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Packaging Packaging Marketing Containment 98

Pharmaceutical Technology

NOVEMBER 15, 2022

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. However, they are not always a first choice. Lowering extractables levels .

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Pharmaceutical Technology

FEBRUARY 3, 2023

CAR T based therapies manufactured with lentiviral vectors are also on the rise, points out Clive Glover, PhD, General Manager, Pall Corporation. Rather, he believes adaptation to suspension-based systems will be an important evolution in AAV manufacturing. Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus.

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Pharma Packaging Solutions

NOVEMBER 8, 2024

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.

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Packaging Packaging Pharma Packaging Compliance 52

pharmaphorum

NOVEMBER 24, 2022

Now, this service-centred model is delivering advantages in the pharmaceutical industry, with costly manufacturing facilities and processes becoming widely available on an on-demand basis. µm per cubic metre – with ISO 9 representing the least stringent measures, while still being significantly cleaner than typical manufacturing facilities.

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Pharmaceutical Technology

MAY 11, 2008

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.

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Drugs Packaging Packaging Production 100

XTalks

MAY 30, 2023

The healthcare industry has one of the heaviest environmental footprints, and manufacturers are increasingly faced with regulations to make more sustainable products,” said Mohammad H. Unfortunately, about 91 percent of this plastic waste from healthcare is not recycled and either ends up in landfills or contaminates natural environments.

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Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

Pharma in Brief

AUGUST 9, 2021

Terms and conditions would be imposed after discussions with the manufacturer and would obligate them to take steps to manage risks and resolve uncertainties. An RMP summarizes the risks of a drug and the pharmacovigilance activities and other measures that a manufacturer puts in place to monitor and manage any identified risks.

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XTalks

FEBRUARY 8, 2024

In 2022, Januvia was flagged for nitrosamine contamination , a potential carcinogen commonly produced as a byproduct during drug manufacturing. The FDA rejected Biocon’s biosimilar in 2023 for the second time over manufacturing concerns at the company’s Malaysia facility and sent Biocon a complete response letter.

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Sales Insulin FDA Approval Drugs 52

Cloudbyz

AUGUST 19, 2024

Medical device safety is a multifaceted discipline encompassing the design, manufacturing, testing, and monitoring of devices throughout their lifecycle. Manufacturers must adhere to a wide array of standards and guidelines that dictate how devices are developed, tested, and brought to market.

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Compliance Manufacturing Regulation Marketing 52

Pharmacy Checkers

DECEMBER 12, 2019

The FDA’s continuing problems with inspections of drug manufacturing plants, as well as the relative comparative strength of other drug regulators, ought to inspire serious reflection, even introspection, among drug safety policy professionals about whether or not, and how, we have the gold standard. Why do I write “exact same”?

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Drugs Manufacturing Medicine Regulation 71

Pharmaceutical Technology

DECEMBER 8, 2022

smart manufacturing is a way of using advanced technology ecosystems to continuously improve product quality, drive savings, and meet demands. In the pharmaceutical industry, this modern approach to manufacturing is increasingly being seen as the best way to meet the high quality requirements demanded of the industry.

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Pharmaceutical Technology

FEBRUARY 3, 2023

Additionally, OSD manufacturing approaches are well developed, with processes that ensure a repeatable distribution of ingredients, uniformity in dissolution, and bioavailability, which verify that the drug product is safe and effective. Compared to other dosage forms, tablets are simpler to manufacture, package, and transport.

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Contamination Manufacturing Containment Production 130

XTalks

JANUARY 28, 2025

It outlines the main touchpoints, including the earliest stages of technical transfer and new product introduction, through formulation development and scalable manufacture, and finally ensuring that these potent products are packaged in a safe environment before global distribution to clinic or market.

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Pharmaceutical Technology

MAY 2, 2023

The pharmaceutical industry is constantly striving for better, cleaner, safer manufacturing, especially when it comes to injectable medicines. 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.

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Packaging Packaging Production Contamination 130

FDA Law Blog

MARCH 9, 2025

John Claud will speak at a session titled Beauty in Developing World Markets: Contrasting Opportunities and Challenges in the Latin American and Chinese Cosmetics Markets, where he will explore two areas of global focus for the cosmetics industry: Latin America and China.

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Cosmetics Compliance Contamination Regulation 59

Pharmaceutical Technology

JANUARY 6, 2023

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. Optimising development and scale-up. Bioburden and microbial testing.

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Production Manufacturing Development Bioequivalency 130

XTalks

NOVEMBER 1, 2024

Sustainable Packaging Solutions Bell Bowls’ Clamshell To-Go Container: Biodegradable Takeaway Bell Bowls tackles single-use waste with a biodegradable clamshell container, crafted from sugarcane-based material. This oven’s AI-driven features also offer insights into temperature regulation and nutrient preservation.

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