RXinsider: Pharmaceutical Quality Control Testing

Analytical Research Laboratories (ARL)

Pharmacy Category:
Pharmacy Compound Analyses • Compounding Quality Control • Pharmaceutical Potency Analysis • Microbial Contamination Testing Services • Laboratory Services • Forensic Toxicology

Analytical Research Laboratories (ARL), a division of ARL Biopharma, has been serving the pharmaceutical and health-related industries since 1994. With over 50 years of combined experience in the industry, ARL can meet and exceed your analytical needs. We offer a full range of professional laboratory services, both analytical and microbiological, as well as consulting services, research and development and forensic legal support. ARL’s professional staff can respond to even the most unusual requests. We use state-of-the-art instrumentation, and provide rapid turnaround time and personal service. Contact us for additional information or a detailed quote.

Laboratory Services
Analytical Research Laboratories (ARL) offers complete analytical services utilizing state-of-the-art instrumentation, including Gas Chromatography (GC), Liquid Chromatography (LC) and Mass Spectrometry (MS). ARL also provides compendial testing according to USP/NF, BP, EP, JP, and ACS monographs. In addition to our analytical testing capabilities ARL has a microbiology department for sterility, fungal, endotoxin testing, cell culture tests, bacterial and fungal identification, and preservative effectiveness testing.

ARL is registered with the Food and Drug Administration (FDA) as an analytical laboratory and the Drug Enforcement Administration (DEA). Analytical Research Laboratories operates in compliance with the Good Laboratory Practice (GLP) and Current Good Manufacturing Practice (cGMP) requirements.

Forensics/Legal
As a forensic toxicologist, Dr. Kupiec has provided consultation and expert witness testimony in the field of forensic toxicology and pharmaceutical sciences. He has testified in over 100 cases in municipal, state and federal courts, involving both civil and criminal issues.

Research and Development
ARL works with clients daily, utilizing cutting edge technology to develop products ranging from pharmaceuticals, medical devices and over-the-counter products to take to market. These services range from consultation contract to providing full laboratory services and outsource services for pharmaceutical companies.

There are many services ARL can provide to be a full service laboratory or to compliment your current in-house laboratory to meet your outsourcing needs.

pharmaceutical product testing NDA / ANDA inspection audit services methodology inspectional drug analysis mycoplasmal contamination cell culture biotech outsourcing validation protocols FDA compliance USP 795 797 cGMP consulting Microbial Taxonomy Pharmaceutical Industrial Microbiology Enumeration microorganism testing protocols Medical Device Biotechnology OTC industries biotechnology microbiological drug device home health care pharmacy aseptic manufacturing biological related sterilization manufacturing process design and control quality control quality assurance regulatory affairs engineering process validation method development systems design and implementation management documentation microbiologists sterility assurance and validation Genetic Profiling Bioburden Particulate Analysis Microbial Identification Sterilization Microbiology Antimicrobial Effectiveness (AME) Limulus Ameobocyte Lysate (LAL) USP 795 and 797 compliance USP 71 requirements forensic testimony legal advise

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DynaLabs®

DynaLabs, LLC, is an analytical laboratory specializing in testing for compounding pharmacists. Through it’s innovative use of technology and it’s patented business processes, DynaLabs has changed the way pharmacists interact with their quality control laboratory. As Your Partner in Compounding, ™ DynaLabs will leverage your testing data and work with you to create more accurate, precise and efficient compounding and business processes. By focusing on the needs of the pharmacist, DynaLabs has built a suite of testing and consulting services targeted at convenience, efficiency and cost effectiveness. These services include, but are not limited to:

Potency / Purity*
Sterility (USP <71>)
Endotoxin (USP <85>)
Particulate Matter (USP <788> & USP <797>)
Consulting Services (USP <795> & USP <797>)

We test the following sterile and non-sterile dosage forms: Syrups, injectables, capsules, tablets, creams, gels, toches, lozenges, suppositories, candy, eye drops, triturations, oils, powders and much more.

Treatment categories include, but are not limited to: Pain Management, Respiratory, Chelating Agents, Anesthetics, Erectile Dysfunction, Chemotherapy, Hormone Replacement, Vitamins, Corticosteroids, Ion Analysis, Antibiotics, Hypertension/Heart, Decongestant, Thyroid, Growth, Anxiolytic, Anti-Nausea, Migraine, Dyes, Lipo-Dissolve, Tuberculosis, Seizure Control, Enzyme, Fertility, Diagnostic Aid, Nutritional, Sympathomimetic, Electrolyte, GERD, Anti-Fungal, Anti-Oxidant, Anti-Viral, Anti-Inflammatory, Anti-Histamine, Stimulants, Muscle Relaxant and more.

DynaLabs… Making state-of-the-art technology work for YOU! For peace of mind and to begin experiencing the DynaLabs Difference™ today call 888-396-2522.
DEA licensed. FDA registered.

* Ask us about our stability indicating assays

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The Pipettech Company

Pharmacy Category:
Pipette Repair & Calibration • Compounding Quality Control Quality Assurance • Compounding Equipment Maintenance

PipetTech

Pipette Repair • Calibration • Preventative Maintenance Services

For nearly 20 years, The Pipettech Company has been a regional leader in the repair, maintenance and calibration of all brands of pipettes, including Gilson, Alphapette, Eppendorf and every other brand of pipette available. All pipettes are thoroughly tested gravimetrically using a certified balance. Gravimetric calibration of pipettes is the most established and widespread method used to calibrate pipettes. Testing a pipette gravimetrically assures the pipette is performing correctly. Pipettes should be calibrated and adjusted under the same conditions in which they are used. The performance of the pipettes must be verified using a certified balance to assure that the pipettes are within manufacturer's specifications.

Pipettech also performs preventative maintenance on pipettes by cleaning, replacing seals, and other worn parts. Pipettes are recalibrated after preventative maintenance is completed using a certified balance to assure the pipette is performing correctly. Pipettes are extremely delicate and accurate instruments, and their accuracy must be checked using a certified balance whenever new parts are replaced. As parts wear due to normal use pipettes tend to pipette lower amounts at the same setting. Only by adjusting the pipette will linearity and accuracy be assured. Pipettech can repair broken pipettes as well as pipettes which are tested to be out of manufacturer's tolerances. Repaired pipettes are recalibrated back to the original manufacturers' specifications.

What can you expect from The Pipettech Company?

Extensively trained technicians
Visual inspection for physical damage
Safe removal of corrosion and rust
Replacement of all worn or broken parts
Replacement of seals and o-rings
Complete gravimetric analysis
Certificate of Calibration Accuracy

The Pipettech Company is based in southern New England, and services their regional clients on location, and nationally, through their mail-order repair service. All services are guaranteed and certified. For more information about The Pipettech Company please contact us using the links below.

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Isensix

Pharmacy Category:
Cleanrooms and Refrigeration, Environmental Monitoring

(Old Manual Way)

(Eliminate Manual Paper Methods)

(View Real-time Status On All Equipment)

(Continuous monitoring and alerts)

WIRELESS TEMPERATURE MONITORING

USP <797> and JCAHO Compliant
Be Prepared For Unannounced Inspections
Isensix is the Vendor of Choice for Top 200 Pharmacies and Medical Centers Nationwide

Currently, staff members are required to manually collect data from refrigerators, freezers, and other types of storage units used to store medication, and chemicals, and either record them on daily log sheets, or collect expired rotary charts. Not only is this practice fraught with numerous inherent problems by relying on human memory and staff already working at their upper limitations, but the ramifications of inaccurate reporting, and the potential negligence of a failing unit, can be extremely costly.

But that was then, this is now, and the future is today! Because by utilizing our patent-pending Advanced Remote Monitoring System (ARMS™) technology, Isensix provides customers with a complete end-to-end enterprise solution. We can monitor a single room or an entire campus. Our 24/7, wireless, real-time solutions eliminate the need for any manual temperature monitoring processes—all without costly changes to facility infrastructure.

Isensix technology provides the following:

Peace-of-mind with the most reliable, highest quality system available
Immediate positive return on investment (ROI) from labor savings and avoidance of loss
Continuous monitoring and alerts for temperature, humidity, air flow, door access & more
User-friendly web-browser
Central data collection record keeping on a secured server with Intranet and Internet remote access
Real-time visual, audio, e-mail, paging, and voice notifications to staff, bio-medical engineering, and staff workstations
Complete training, validation, calibration, documentation to meet JCAHO and USP <797> requirements
Fully compliant with FDA 21CFR Section 11 Electronic Signature
Automated compliance reporting, corrective action logs, and back-up

For more information about our products, please use the links below to contact us or visit our website.

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Pharmaceutical Quality Control Labs / Laboratory Testing Services Microbial Contamination Detection & Testing Services