Avista Pharma Solutions - your capable, dependable partner – is a contract testing, development and manufacturing organization
Environmental Monitoring. Properly designed and executed sterilization validations are critical to ensuring the sterilization process is capable of achieving the intended sterility assurance level (SAL).
An SAL of 10-6, meaning there is a probability of only 1 non-sterile device in every 1 million sterilized, is most common with today’s sterilization processes. With over 30 years of experience, Avista Pharma offers superior expertise and high quality testing to support your radiation (gamma/e-beam) and gaseous (Ethylene Oxide) sterilization validations and monitoring. Avista Pharma’s experts have years of experience in sterility, bioburden and ethylene oxide residual testing. Avista Pharma has also fostered good relationships with leading industrial sterilizers and work closely with them on clients’ sterilization projects.
This networking makes the sterilization validation process very streamlined. Our testing services include: Bioburden testing: performed per ANSI/AAMI/ISO guidelines. Analytical Testing & Development. Process Chemistry Services. Analytical Testing & Development. Drug Product Research and Development. Pharma Solutions, Testing, Development & Manufacturing. Environmental Monitoring. Mark J. Kontny, Ph.D. Named to Board of Directors of Avista Pharma Solutions. DURHAM, N.C., Dec. 20, 2016 /PRNewswire/ — Avista Pharma Solutions, Inc.
(“Avista Pharma”) is pleased to announce that Mark J. Kontny, Ph.D. has joined its team as a member of its Board of Directors (BOD). Dr. Kontny is a significant voice for the Life Sciences industry and has extensive experience in formulation, pharmaceutical product development and manufacturing. His previous industry roles include President, Pharmaceutical Development Services and Chief Scientific Officer for Patheon, Divisional VP, Global Pharmaceutical and Analytical Sciences for Abbott Laboratories, Senior Director for Pharmacia/Monsanto/GD Searle and nearly ten years at Boehringer Ingelheim Pharmaceuticals.
“We are delighted that Dr. “Avista Pharma has quickly emerged as a leader in the CDMO industry, investing in comprehensive capabilities across multiple locations, and has a very experienced management team,” said Dr. Dr. Avista Pharma Solutions Expands Microbiology, Sterility Testing and Microbial ID Capabilities At Agawam Facility. AGAWAM, Mass., March 21, 2017 – Avista Pharma Solutions, Inc.
(“Avista Pharma”) today announced at the annual Interphex global conference in New York City that the $4 million expansion of its 26,000-square foot contract testing facility in Agawam, Massachusetts is now complete. For over 30 years, the Agawam site has provided superior service to pharmaceutical and medical device clients, and as part of an ongoing initiative, these facility and technology upgrades will enable Avista Pharma to deliver additional microbiology, sterility testing, and microbial ID service offerings. As the result of Avista Pharma’s 2016 capital investment, the improved facility has 4,200 square feet of additional space, featuring a new microbiology laboratory as well as a modular cleanroom area which houses isolator technology and an ISO 6 cleanroom used for sterility testing of medical devices, pharmaceuticals, and biologics.
How Do Pharmaceutical Laboratories Avoid Drug Adulteration? – Microbiological Testing Blog. Cleaning is an essential part of any drug manufacturing process to ensure the validity of its results and prevent adulteration that could potentially harm people or affect testing.
This is why pharmaceutical companies must comply with cleaning validation standards that adhere to Good Manufacturing Practice (GMP) and Quality Systems Regulations (QSR). In addition to that, cleaning validation allows drug companies to bring drugs to market quicker and at a lower cost. Although it may feel time-consuming, cleaning validation is necessary to ensure adulteration doesn’t take place. Basically, adulteration means that there is some semblance of cleaning product or remaining product after the batch has been manufactured. In order to avoid this, pharmaceutical companies will enlist the services of a third-party microbiological testing provider to help them certify validation. Companies will perform the following services to help companies certify their validation: Like this: Like Loading...
What Is a Cleanroom? – Cleanroom Certification 101. A cleanroom is a controlled environment that has the lowest level of small particles to avoid contamination.
These pollutants could include dust, airborne microbes, aerosol, chemical vapors, mold, skin cells, and more. In any environment, there are millions of small particles that are in the air. A cleanroom is designed to control the number of contaminants as much as possible. There are a number of industries where preventing contamination is crucial.
Pharmaceutical companiesMedical device companiesSemiconductor manufacturersBiotechnology firmsAerospace components manufacturersMilitary equipment manufacturersMedical research labs Cleanrooms vary in size, complexity, and layout, but they all are constructed to reduce airborne particles to prevent contamination. Besides filters, all personnel will be required to wear special clothing that traps particles and may be required to wear up to a bunny suit with a mask if the application calls for it. Like this: Like Loading... Cleanroom Services & Compressed Air Testing. How Do Pharmaceutical Laboratories Avoid Drug Adulteration? – Microbiological Testing Blog.
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