XTalks

MAY 19, 2022

According to the company, products were manufactured by a third party and subsequently distributed across North America. Rather, they are specific packages of the “Gummies” variety of these products. So why is metal contamination such a common reason for launching voluntary recalls? And any foreign object less than 0.3

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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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XTalks

FEBRUARY 5, 2021

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.

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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

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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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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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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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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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Pharmaceutical Technology

JANUARY 12, 2023

That would not allow sufficient time to manufacture, package and distribute before half of the content was degraded. For more information about how Baxter BioPharma Solutions manufacturing expertise can support your project, dow nload the paper below. . Solid state reactions occur much more slowly than liquid interactions.

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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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