Berkshire Sterile
Berkshire Sterile
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Reaching the Patient: Optimizing Labeling, Packaging, and Distribution
This webinar offers a comprehensive exploration of the process of getting your product to the patient following fill finish. We cover essential topics such as how your product is labeled, packaged, shipped, and distributed, with a focus on requirements for labels and packaging, and options to best suit you and your patients' needs.
We cover clinical technologies that optimize clinical trial inventory management and provide solutions for patient randomization.
00:00 - Intro
01:12 - Process
02:30 - Labelling
05:45 - Distribution
09:02 - Clinical Trial Technologies
15:00 - Conclusion
zhlédnutí: 223

Video

Navigate the FDA and Annex 1: Essential Rules & Regulations for Quality Fill-Finish
zhlédnutí 556Před 2 měsíci
This webinar offers a comprehensive exploration of critical topics within parenteral drug product manufacturing, including regulatory guidelines, essential analytical and microbial testing, and phase-specific considerations. We delve into emerging trends such as Pre-Use Post-Sterilization Integrity Testing (PUPSIT) and Container Closure Integrity Testing (CCIT), as well as highlight common pitf...
Pharmaceutical Manufacturing: Solving Common Fill-Finish Challenges
zhlédnutí 895Před 3 měsíci
This video focuses on strategies to enhance fill quality, manage drug product sensitivities, and minimize product loss. This event will offer useful information for any sponsor of a parenteral drug product, but especially for those that require special equipment or container closure systems, lyophilization, or mitigation strategies to manage product sensitivities. What you'll learn: - How to op...
Discover Aseptic Fill-Finish - A Critical Step in Parenteral Manufacturing
zhlédnutí 2,6KPřed 4 měsíci
Transform your understanding of the pharmaceutical manufacturing world with our latest episode, "Introduction to Fill Finish," streamed live on March 6, 2024. Dive into the critical process of aseptic fill-finish, a cornerstone in the production of high-quality parenteral drug products. Perfect for newcomers in the field of parenteral drug manufacturing, this webinar is designed to equip you wi...
2024 Holiday Party at BSM
zhlédnutí 89Před 5 měsíci
Last weekend marked our annual holiday party, and we celebrated a great year! With raffle prizes, Christmas gifts, and awards for employees hitting their five-year anniversary, we enjoyed delicious food, drinks, and dancing. Almost 70% of our 230 team made it. BSM isn't just a place to work; it's where life-long friendships are formed. We caught a few snaps towards the end - even our photograph...
Filling challenges for intravitreal and intraocular drug products
zhlédnutí 344Před 8 měsíci
Intravitreal (IVT) drug products assume a pivotal role in treating retinal disease often used to prevent or reverse damage that could lead to blindness. The production of these drugs present unique challenges and involve specific requirements. Join our webinar as we dive into the unique aspects of manufacturing IVT drugs, explore strategies to minimize volume loss during the fill-finish process...
A Vial's Journey - the 360° VR Journey of Injectable Drug Production
zhlédnutí 46KPřed 8 měsíci
Step into the captivating world of parenteral production, packaging, and distribution with our 360° virtual reality video. Witness the entire lifecycle of an injectable drug, from concept to manufacturing to disposition. From the cleanrooms in Lee, Massachusetts, to Sharp's clinical facility in Bethlehem, Pennsylvania, explore the intricate processes that bring life-saving medicines to patients...
Thank YOU for 1,000 Youtube Subscribers!
zhlédnutí 51Před 9 měsíci
We just wanted to hop on here to say thank you for following our channel and watching our videos! What started as an initiative to share more about our automated filling line has developed into a place to share in-depth information about the exciting world of parenteral manufacturing! Our goal with this channel is to make information in this field more accessible so that sponsors can make bette...
Berkshire Sterile Manufacturing & Sharp describe their shared offering
zhlédnutí 875Před 9 měsíci
Berkshire Sterile Manufacturing and Sharp describe how they work together to deliver an end-to-end service for injectable drug products with a focus on quality. To learn more about Berkshire Sterile Manufacturing, please visit our website: berkshiresterilemanufacturing.com/ To learn more about Sharp, please visit their website: www.sharpservices.com/
The ABC's of Formulation Development for Parenteral Drug Product Manufacturing
zhlédnutí 2,6KPřed 10 měsíci
For many pharmaceutical and biotech companies entering preclinical and clinical studies, their formulation is still in development. While most have prepared the formulation in their own lab, developing a formulation for sterile fill finish is a different challenge requiring different information. How do you scale up your formulation? Can your product be sterile filtered? How do you maintain hom...
Automated Vial Filling
zhlédnutí 1,1KPřed 10 měsíci
Automated Vial Filling
Semi-Automated Visual Inspection of Vials
zhlédnutí 2KPřed rokem
Semi-Automated Visual Inspection of Vials
Clinical Scale Lyophilizer Loading at Berkshire Sterile Manufacturing
zhlédnutí 653Před rokem
Clinical Scale Lyophilizer Loading at Berkshire Sterile Manufacturing
Unique Challenges of Specialty Container Sterile Filling
zhlédnutí 703Před rokem
Unique Challenges of Specialty Container Sterile Filling
Aseptic filling of unstable drug products
zhlédnutí 2KPřed rokem
Aseptic filling of unstable drug products
10 women describe working at Berkshire Sterile Manufacturing
zhlédnutí 207Před rokem
10 women describe working at Berkshire Sterile Manufacturing
Advice from 10 Women in STEM
zhlédnutí 140Před rokem
Advice from 10 Women in STEM
Fully automated sterile filling line at Berkshire Sterile Manufacturing
zhlédnutí 2,8KPřed rokem
Fully automated sterile filling line at Berkshire Sterile Manufacturing
Why your container closure choice matters in sterile fill finish
zhlédnutí 1,7KPřed rokem
Why your container closure choice matters in sterile fill finish
Introducing the Future of Sterile Filling - Berkshire Sterile Manufacturing
zhlédnutí 11KPřed rokem
Introducing the Future of Sterile Filling - Berkshire Sterile Manufacturing
Reducing loss in fill finish for high-value drug products
zhlédnutí 1,3KPřed rokem
Reducing loss in fill finish for high-value drug products
Low Loss Fill Process
zhlédnutí 782Před rokem
Low Loss Fill Process
Automated Vial Filling & Lyophilization
zhlédnutí 26KPřed rokem
Automated Vial Filling & Lyophilization
Berkshire Sterile Manufacturing marches in the 2022 Lee Founders Day Parade
zhlédnutí 86Před rokem
Berkshire Sterile Manufacturing marches in the 2022 Lee Founders Day Parade
Aseptic filling techniques for highly viscous drug products
zhlédnutí 2,1KPřed rokem
Aseptic filling techniques for highly viscous drug products
Robotic Filling of Syringes at Berkshire Sterile
zhlédnutí 7KPřed rokem
Robotic Filling of Syringes at Berkshire Sterile
Sterility Isolator Ribbon Cutting
zhlédnutí 92Před rokem
Sterility Isolator Ribbon Cutting
Take a Tour of Berkshire Sterile Manufacturing!
zhlédnutí 1,2KPřed 2 lety
Take a Tour of Berkshire Sterile Manufacturing!
Enhancing sterility assurance in isolator-based aseptic filling
zhlédnutí 1,9KPřed 2 lety
Enhancing sterility assurance in isolator-based aseptic filling
Engineering Runs in Fill Finish - What are they and are they necessary?
zhlédnutí 1,6KPřed 2 lety
Engineering Runs in Fill Finish - What are they and are they necessary?

Komentáře

  • @STARBOY-ko4kb
    @STARBOY-ko4kb Před 11 hodinami

    💀

  • @fishingologist5074
    @fishingologist5074 Před 2 měsíci

    Thank you! This was very helpful.

  • @allenmorales959
    @allenmorales959 Před 3 měsíci

    😍 'Promosm'

  • @reddyshivuprakash1752
    @reddyshivuprakash1752 Před 4 měsíci

    Very nice presentation

  • @sivateja2022
    @sivateja2022 Před 5 měsíci

    Thank You!! Excellent presentation.

  • @happyandhealthy888
    @happyandhealthy888 Před 5 měsíci

    What Nature wants to know through AI

  • @narayananr2982
    @narayananr2982 Před 6 měsíci

    Do you know the price of this machine?

  • @omofolawaalimi-adeniran631
    @omofolawaalimi-adeniran631 Před 6 měsíci

    It is indeed the future of sterile manufacturing! well done team!

  • @faraazYNV
    @faraazYNV Před 6 měsíci

    great explanation, good for my interview

  • @sivateja2022
    @sivateja2022 Před 7 měsíci

    Great Video on Media Fill

  • @traininintern007
    @traininintern007 Před 8 měsíci

    what happened to your hair.. you look completely different

  • @a-aron2276
    @a-aron2276 Před 8 měsíci

    I know it's sterile but how it particulate free with all those moving parts is impressive. The sheer volume of airflow through that room must be insane. 60+ acph ?

  • @user-us7yy2lq8i
    @user-us7yy2lq8i Před 8 měsíci

    Excellent subjective presentation.

  • @user-us7yy2lq8i
    @user-us7yy2lq8i Před 8 měsíci

    Excellent subjective presentation.

  • @faraazYNV
    @faraazYNV Před 8 měsíci

    Thank you for the presentation. very helpful for my interview

  • @kishoresahu836
    @kishoresahu836 Před 9 měsíci

    Thank you for this information

  • @rakeshnayek
    @rakeshnayek Před 9 měsíci

    Any contact no for third party manufacturing

  • @roja622
    @roja622 Před 9 měsíci

    Very energetic from continuous presentations and valuable information ..all the best..

  • @TheGeneralinTheBunker
    @TheGeneralinTheBunker Před 9 měsíci

    First

  • @PeterHarket
    @PeterHarket Před 10 měsíci

    Hi there. I've been trying to reach out to BSM through the contact form, but to no avail, so I'll try my luck with a nudge here.

  • @bharathgoud8409
    @bharathgoud8409 Před 11 měsíci

    god videos very informative, god job

  • @pantin_enrique
    @pantin_enrique Před 11 měsíci

    is the top of the rubber stopper and the bottom of the hard external plastic cover sterile?

  • @howtoget65556
    @howtoget65556 Před rokem

    good leanrnings, thank you.

  • @manishgupta3996
    @manishgupta3996 Před rokem

    what is BI?

  • @manishgupta3996
    @manishgupta3996 Před rokem

    Hi..its a nice video... At 41.28, if I may ask what is the difference between sanitization and sterilization process?

  • @benekcik
    @benekcik Před rokem

    Very useful information. Thank you...

  • @wasimabbasi2664
    @wasimabbasi2664 Před rokem

    nice presentation

  • @jamesmackenzie5074
    @jamesmackenzie5074 Před rokem

    All the videos in this series have been excellent. Thanks for being so transparent. J

  • @jamesmackenzie5074
    @jamesmackenzie5074 Před rokem

    I'm not new in the Pharmaceutical industry having worked in OSD for almost 30 years, but I am new in parenterals. This Webinar was super helpful. Thank you.

  • @meriemsanaakhelif4462

    thank you for this presentation

  • @jessen00001
    @jessen00001 Před rokem

    Very nice. Thanks

  • @jessen00001
    @jessen00001 Před rokem

    Very interesting. Thanks

  • @KiranReddyPippirada

    Do you have risk assessment for vhp isolator

  • @KiranReddyPippirada

    Good explanation

  • @Victoriawakeup
    @Victoriawakeup Před rokem

    I've heard that geobacillus is now not acceptable and in turn bi's are not ideal indicators of activity - what the heck do regulators expect people to use!!??

  • @jessen00001
    @jessen00001 Před rokem

    Great webinar Sarah 👍 Thanks 😊

  • @jessen00001
    @jessen00001 Před rokem

    Great video. Thanks

  • @vilassawant6266
    @vilassawant6266 Před rokem

    Excellent Presentation......

  • @ariel_monzon
    @ariel_monzon Před rokem

    Very impressive! I appreciate the production behind this video and have shared it with colleagues.

  • @ariel_monzon
    @ariel_monzon Před rokem

    great video!

  • @Ranjan1315
    @Ranjan1315 Před rokem

    Nice slides… good info …

  • @Pharma_Education_by_Sameer

    Very valuable information

  • @Chandrahas.Parihar
    @Chandrahas.Parihar Před 2 lety

    During vial filling and PFS filling movement should be avoid, linear lines are the best line for filling operation with minimum movement

  • @johncronin2999
    @johncronin2999 Před 2 lety

    Thank you for the wonderful presentation! I've worked on different types of filing lines, from enclosures, to RABs and isolators. I really appreciate this. 👍👍

  • @mahinhossain6559
    @mahinhossain6559 Před 2 lety

    How sealing integrity checke

  • @deporlover
    @deporlover Před 2 lety

    Nice presentation 👍👍

  • @allenhayes3001
    @allenhayes3001 Před 3 lety

    Awesome!! Glad I found your videos. You should think about using SMZeus . c o m!!! It’s a handy tool to help grow your channel.