Lyophilization/Freeze
Drying Technologies
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We have extensive
knowledge and expertise in the utilization of lyophilization (freeze
drying) technologies for the development, manufacture, quality control and
productivity improvements of many products, especially for the medical
device and pharmaceutical industries.
Lessons Learned.
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Here are some hot
tips for you gained through our many years of experience:
- Establish the claims,
features and benefits that the freeze dried product needs to satisfy.
Among them is re-hydration, solubility and/or dissolution rates;
pharmaco-kinetic efficacy rates; potency and stability; shelf life,
etc.
- Develop and optimize the
chemical composition of the solution or mixture to be
lyophilized.
- Establish the proper
conditioning of the utilized materials before preparation of the final
solution or mixture. In depth, scientific understanding of the
chemical, physical properties of each material and any possible
interactions thereof is an absolute requirement to proactively
eliminating major quality, performance and cost problems.
- Have full knowledge of
the physical and chemical properties of the bottle, tray or any other
container where the lyophilized solution or mixture will be stored
from raw materials to finished, packaged product. Incomplete cleaning
or surface preparation as well as contamination, all are capable of
creating major headaches for any manufacturer.
- Have thorough
understanding of the current state of the employed manufacturing
equipment and process, i.e. lyophilizer; liquid dispenser;
solution/mixture preparation equipment; training and work load
of engaged personnel. Timely conducted audits of both the process and
personnel are a "must."
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403 Christie Ct.,
Stewartsville, NJ 08886 USA
Costas B. Chantzis,
CEO
Tel.:
908.387.9276
Fax: 908.387.0447 Email
Home
Home
Who We Are
Unique Strengths
Our Services
Projects Resume
Your Next Step
Write Us
What's New
Articles
Ask
SolvWizSM For FREE
TechnoBusiness
Solutions
403 Christie Ct.,
Stewartsville, NJ 08886 USA
Costas B. Chantzis, CEO
Tel.:
908.387.9276
Fax: 908.387.0447 Email
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