Quality Assurance and Control

Downing Labs LLCQuality Assurance and Control

New Quality Assurance Program Implemented
Downing Labs has invested heavily in a Quality Management Program that consists of both Quality Assurance and Quality Control. Working under FDA, State Board of Pharmacy and DEA jurisdiction, our pharmacy ensures patient safety and product quality at its highest level. Below are just few examples of systems implemented.

 

01

Equipment Validation

Downing Labs ensures quality control through the validation of all of its equipment that is currently used production by meeting the installation, procedural, and operational qualifications, to ensure that each piece of equipment in its facility is functioning to the highest standards.

02

ISO-Certified Clean Rooms

Downing Labs has re-certified all its ISO-5, ISO-7, and ISO-8 clean rooms before the bi-annual due date.  We are also happy to announce that we’ve achieved an ISO-2 rating for our clean room hood, surpassing its ISO-5 level requirements.

03

New Cleaning Equipment

Our state-of-the-art Sanosil Halo Fogger cleaning system dispenses a sanitizing fogafter each day’s production.  The fog consists of a sporicidal agent which includes a  hydrogen peroxide / silver nitration solution that provides  a 99.99% kill rate of microorganisms. In addition to cleaning, the Sanosoil is used for monitoring the sanitation of the non-sterile lab to validate the cleanliness of the entire environment.

04

Environmental Monitoring

Downing Labs has developed new environmental monitoring procedures that involve the following: continuous 24×7 non-viable air sampling, daily viable air sampling, daily surface sampling, daily fingertip testing, and continuous pressure, temperature and humidity monitoring, exceeding current USP requirements.

This includes the use of facility monitoring software that provides real-time event monitoring, alerting, and reporting of current lab conditions, e.g. pressure, temperature, relative humidity, non-viable air particulate data, etc.

05

New Water Filtration Process

Downing Labs has updated its water source for all compounding production  by utilizing a deionized carbon filtered system.  This water is tested quarterly by a 3rd party vendor.  In addition, the water system utilizes a  monitoring system to alert if water is out of specification.

06

New Laminar Flow Hoods

We have also purchased new state of the art flow hoods for the weighing, mixing, encapsulating, and packing of chemicals. All hoods have been custom designed- according to both our inventory type and the quantity of chemicals used  for non-sterile production.  This equipment also undergoes an annual 3rd party recertification process.

07

High Performance Refrigeration Systems

All refrigerators used in the storage of our compounded products now leverage  high-performance refrigerators.  This equipment also utilizes an environmental monitoring \ alarm system, for 24×7 coverage, in the event the temperature varies above or below a predefined range.  All refrigerators and monitoring system have also been validated by a third party vendor.

08

FPC-50 Automatic Filling/Stoppering/Capping Machine

Downing Labs has recently purchased a state-of-the-art filling device for all sterile compounded orders.  The process begins by the liquid first being sterilized by passing through a .2 micron filter which is automatically dispensed into vials via gamma irradiated tubing and peristalsis.  The machine then automatically seals the vial with sterilized and depyrogenated stoppers, including a sterilized cap.

Downing Labs is committed to the highest standards of integrity and customer service. We pride ourselves on our record of providing exceptional customer service and delivering high quality customized medications. CLICK HERE to contact us.

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P. 800 914 7435
P. 214 347 4008
F. 888 839 0241

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