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Sharp Sterile
เข้าร่วมเมื่อ 17 มี.ค. 2020
Sharp Sterile (formerly Berkshire Sterile Manufacturing) provides the safest sterile drug products for clinical use and small scale requirements through the use of modern technology, 100% isolator-based filling lines, and a skilled staff.
We offer sterile filling of syringes, vials (RTU and bulk), cartridges, custom containers, and lyophilized product. We also provide onsite analytical support, stability programs, and development services.
Sharp Sterile will always be a customer-focused, quality-driven contract manufacturer of sterile injectables. We meet your changing requirements and critical deadlines. Reach out to us today for a free quote.
We offer sterile filling of syringes, vials (RTU and bulk), cartridges, custom containers, and lyophilized product. We also provide onsite analytical support, stability programs, and development services.
Sharp Sterile will always be a customer-focused, quality-driven contract manufacturer of sterile injectables. We meet your changing requirements and critical deadlines. Reach out to us today for a free quote.
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
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
มุมมอง: 668
วีดีโอ
Navigate the FDA and Annex 1: Essential Rules & Regulations for Quality Fill-Finish
มุมมอง 1.8K8 หลายเดือนก่อน
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
มุมมอง 2.7K10 หลายเดือนก่อน
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
มุมมอง 8K11 หลายเดือนก่อน
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
มุมมอง 111ปีที่แล้ว
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
มุมมอง 590ปีที่แล้ว
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
มุมมอง 49Kปีที่แล้ว
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!
มุมมอง 53ปีที่แล้ว
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
มุมมอง 1.2Kปีที่แล้ว
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
มุมมอง 4.5Kปีที่แล้ว
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...
Semi-Automated Visual Inspection of Vials
มุมมอง 3.3Kปีที่แล้ว
Semi-Automated Visual Inspection of Vials
Clinical Scale Lyophilizer Loading at Berkshire Sterile Manufacturing
มุมมอง 1Kปีที่แล้ว
Clinical Scale Lyophilizer Loading at Berkshire Sterile Manufacturing
Unique Challenges of Specialty Container Sterile Filling
มุมมอง 1.1Kปีที่แล้ว
Unique Challenges of Specialty Container Sterile Filling
Aseptic filling of unstable drug products
มุมมอง 3.2Kปีที่แล้ว
Aseptic filling of unstable drug products
10 women describe working at Berkshire Sterile Manufacturing
มุมมอง 245ปีที่แล้ว
10 women describe working at Berkshire Sterile Manufacturing
Fully automated sterile filling line at Berkshire Sterile Manufacturing
มุมมอง 3.4K2 ปีที่แล้ว
Fully automated sterile filling line at Berkshire Sterile Manufacturing
Why your container closure choice matters in sterile fill finish
มุมมอง 2.5K2 ปีที่แล้ว
Why your container closure choice matters in sterile fill finish
Introducing the Future of Sterile Filling - Berkshire Sterile Manufacturing
มุมมอง 17K2 ปีที่แล้ว
Introducing the Future of Sterile Filling - Berkshire Sterile Manufacturing
Reducing loss in fill finish for high-value drug products
มุมมอง 1.5K2 ปีที่แล้ว
Reducing loss in fill finish for high-value drug products
Automated Vial Filling & Lyophilization
มุมมอง 36K2 ปีที่แล้ว
Automated Vial Filling & Lyophilization
Berkshire Sterile Manufacturing marches in the 2022 Lee Founders Day Parade
มุมมอง 952 ปีที่แล้ว
Berkshire Sterile Manufacturing marches in the 2022 Lee Founders Day Parade
Aseptic filling techniques for highly viscous drug products
มุมมอง 2.8K2 ปีที่แล้ว
Aseptic filling techniques for highly viscous drug products
Robotic Filling of Syringes at Berkshire Sterile
มุมมอง 9K2 ปีที่แล้ว
Robotic Filling of Syringes at Berkshire Sterile
Take a Tour of Berkshire Sterile Manufacturing!
มุมมอง 1.6K2 ปีที่แล้ว
Take a Tour of Berkshire Sterile Manufacturing!
Enhancing sterility assurance in isolator-based aseptic filling
มุมมอง 2.6K2 ปีที่แล้ว
Enhancing sterility assurance in isolator-based aseptic filling
Engineering Runs in Fill Finish - What are they and are they necessary?
มุมมอง 1.8K2 ปีที่แล้ว
Engineering Runs in Fill Finish - What are they and are they necessary?
Feni Bangladesh Precedent in world Shyful Islam 2015 uffical
I would like to know more about what it takes to be compliant with part 11 and e-signatures. Is the relevant personnel signing off on the document with a typed signature enough or should a more involved system such as docusign be implemented?
That was quite interesting to watch, our production line is made from 2005, so waiting to renovate it when it will be possible.
Thanks, that was very delightful.
great
great
H
What an awesome video!!! I have been working in this industry for 11 years. Great synopsis of the business.
💀
Thank you! This was very helpful.
😍 'Promosm'
Very nice presentation
Thank You!! Excellent presentation.
What Nature wants to know through AI
Do you know the price of this machine?
It is indeed the future of sterile manufacturing! well done team!
great explanation, good for my interview
Great Video on Media Fill
what happened to your hair.. you look completely different
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 ?
Excellent subjective presentation.
Excellent subjective presentation.
Thank you for the presentation. very helpful for my interview
Thank you for this information
Any contact no for third party manufacturing
Very energetic from continuous presentations and valuable information ..all the best..
I would offer him a glass of water, if I was in the live section.
First
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.
god videos very informative, god job
is the top of the rubber stopper and the bottom of the hard external plastic cover sterile?
good leanrnings, thank you.
what is BI?
Biological Indicators
Hi..its a nice video... At 41.28, if I may ask what is the difference between sanitization and sterilization process?
Very useful information. Thank you...
nice presentation
All the videos in this series have been excellent. Thanks for being so transparent. J
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.
thank you for this presentation
Very nice. Thanks
Very interesting. Thanks
Do you have risk assessment for vhp isolator
Good explanation
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!!??
Great webinar Sarah 👍 Thanks 😊
Great video. Thanks
Excellent Presentation......
Very impressive! I appreciate the production behind this video and have shared it with colleagues.
great video!
Nice slides… good info …
A¥. ¥.
Very valuable information