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Catalogue: Standard cleanroom POD
G-CON’s standard POD maximises efficiencies in production, qualification and cost and eliminates the complexity of cleanroom construction projects.
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Freeze Drying
webinar
A holistic strategy to ensure container closure integrity of sterile vials
11 February 2021 | By Lighthouse Instruments
Watch our on-demand webinar where we describe a more science-based holistic approach to ensure CCI; a framework that includes robust design and qualification of the process and the implementation of appropriate process controls is required.
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Brochure: G-CON cleanroom POD
G-CON cleanroom PODs. Reliable, flexible prefabricated cleanrooms for the biopharmaceutical industry. On budget and on time.
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Article: CCI test method development using headspace gas ingress
Update your blue dye ingress test and generate robust analytical CCI data in all stages of the product life cycle.
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Article: Regulatory guidance in designing a CCI testing strategy
A summary of the current state of container closure integrity testing in the pharmaceutical industry.
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Case study: Challenges in manufacturing high value lyophilised oncology drugs
Key features of a custom-made freeze-drying integrated solution.
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Case study: Upgrade of an existing sterile production room of freeze-dried vaccines to comply with the requirements of the new GMP annex 1
Challenges in day to day operations. The battle of performance in production.
news
Importance of sublimation tests when freeze-drying HPAPIs shown in study
Researchers have shown that sublimation tests should be conducted if new components are added to the freeze-drying process of HPAPIs.
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Russia’s Sputnik V COVID-19 vaccine safely elicits an antibody response, reports paper
Preliminary data from Phase I/II trails evaluating the vaccine reveal 100 percent of participants had a humoral and cellular response, with no serious adverse events reported.
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Telstar develops a new laboratory freeze dryer operating with natural gases
Specially designed for R&D laboratories, Telstar's LyoQuest Arctic is a bench-top environmentally friendly lab freeze dryer. Unlike conventional freeze dryers using HFC cooling gases, the Lyoquest Arctic reduces the GWP impact more than 1,000-fold.
webinar
A 360 overview of data integrity in life sciences
7 February 2020 | By OSIsoft
Trustworthiness in data is critical for operations within the pharmaceutical and life sciences industries, whether it is for compliance, operational excellence, reporting or development. Hear the latest findings from OSIsoft’s research in our on-demand webinar.
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Case Study: Controlled Nucleation: more than just a homogenization tool
Optimizing the freeze-drying pharmaceutical process.
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Telstar promotes aseptic technology developments for pharma production
At CPhI (Frankfurt, November 5-7 2019), Telstar will be promoting the latest solutions in isolation technology systems, sterilisation and pharmaceutical freeze-drying applications, designed to ensure an aseptic and efficient production of pharmaceutical processes.
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Expert View: Reaching for the (lyo) stars – the unmatched development and scale-up platform for freeze drying
This article focuses on how formulation data can be utilised to create optimal freeze-drying cycles for a specific product based on the unique process analytical technology (PAT) tools and technologies available in SP Scientific’s LyoStar™ 3, a leading freeze dryer for cycle development.
