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ACTA Laboratories provides leading-edge consulting and analytical testing services to the pharmaceutical industry. Services include:
| Sterilant and Disinfectant Residue Testing | Biological Tests and Assays |
| Leachability Studies | Microbiological Testing |
| Drug Compatibility Studies | Stability Studies |
- Ethylene Oxide
- Ethylene Chlorohydrin
- Ethylene Glycol
- Gluteraldehyde
- Formaldehyde
ACTA analyzes for evidence of leaching of Polymer additives into drug products using chromatographic techniques.
ACTA performs similar Leachability Studies for elemental impurities down to ultra-trace levels using an Inductively Coupled Plasma Mass Spectrometer (ICP-MS).
ACTA performs studies to validate the compatibility of specific drugs with drug infusion systems using various Instrumentation.
ACTA performs testing for validation and routine monitoring of water systems
- USP <643> Total Organic Carbon
- USP <645> Water Conductivity
- USP <788> Particulate Matter
- Wet chemical analyses for packaged water in accordance with USP monographs
- Total Aerobic Microbial Count
- Total Coliforms Count
- Screening for Pseudomonas aeruginosa
- USP <85> Bacterial Endotoxins Test
- Autoclave Feed Water and Steam testing for conformance with ISO 11134
ACTA performs the following Biological Tests and Assays
- USP <85> Bacterial Endotoxins Test
- USP <87> Biological Reactivity Tests, In-Vitro
Agar Diffusion Test
Direct Contact Test
Elution Test
- ISO 10993-5 tests for In-Vitro cytotoxicity
Agar Diffusion Test
Direct Contact Test
Test on Extracts
- Inhibition of Cell Growth (ICG) test on aqueous extracts per FDA Guidelines
ACTA performs Bioburden testing of medical devices and components.
ACTA performs Validation of Bioburden recovery by exhaustive extraction or product innoculation
ACTA performs the following test from USP <55> Biological Indicators-Resistance Performance Tests
- Total Viable Spore Count
ACTA performs the following test from USP <71> Sterility Tests
- Validation Tests for Bacteriostasis and Fungistasis
ACTA generates Stability Protocols
for the study and tracks your samples carefully to ensure that they are tested in a timely manner.
ACTA has a standby generator that maintains power to the stability chambers in the event of a power failure and an alarm system that will page the Director of QA/QC in the event that any stability chamber fails to maintain its humidity or temperature setpoints. These controls ensure that stability samples will be stored as required.
ACTA has a stability chamber maintained at the ISO accelerated storage condition for Medical Devices (45° C / > 40% RH)
ACTA develops methods for non-compendial products and for compendial products that need stability indicating methods. ACTA’s staff is experienced with method development for all types of dosage forms. Using various Instrumentation, ACTA develops rugged and accurate methods to meet your requirements.
ACTA validates methods in accordance with USP and ICH requirements. ACTA prepares Validation Protocols for the study and will furnish you with a Validation Report that will meet the FDA’s expectations.
ACTA generates Stability Protocols for the study and tracks your samples carefully to ensure that they are tested in a timely manner.
ACTA has a standby generator that maintains power to the stability chambers in the event of a power failure and an alarm system that will page the Director of QA/QC in the event that any stability chamber fails to maintain its humidity or temperature setpoints. These controls ensure that stability samples will be stored as required.
ACTA has a stability chamber maintained at the ISO accelerated storage condition for Medical Devices (45° C / > 40% RH)