Stability Storage and Testing Services

Product Description

Pace analytical life sciences llc offers wide range of services which includes stability testing and storage service. It provides secure long- and short-term (accelerated) storage and stability testing to support cgmp stability programs. It offer a broad range of conditions—temperature only, temperature and humidity, photostability, cycling and freeze/thaw—that supports ich guidelines. Its custom storage conditions are available to support your specific procedures and timelines—whether it require storage only, storage and testing, testing only, and/or project management assistance. Plus, stability reports can be tailored to meet the needs. Contact us for more information.

Pace Analytical Life Sciences, LLC

  • US
  • 2017
    On CPhI since
  • 4
    Certificates
  • 250 - 499
    Employees
Contract Service
Specifications
  • Selling Points
    Quality Service
  • Supplied from
    United States

Pace Analytical Life Sciences, LLC

  • US
  • 2017
    On CPhI since
  • 4
    Certificates
  • 250 - 499
    Employees
Contract Service

More Products from Pace Analytical Life Sciences, LLC

  • Pharmaceutical / Biopharmaceutical Testing Services

    Product Pharmaceutical / Biopharmaceutical Testing Services

    Pace analytical life sciences llc offers wide range of services which includes product release testing for pharmaceuticals service. It provides pharmaceutical product release testing for both qa pharmaceutical release testing and clinical release testing. It offer quality assurance/quality control product release testing services that provide fast, timely and accurate analyses of time sensitive products that are to be released and distributed to the commercial marketplace. It has an experience in testing all types of pharmaceutical products, including solid dosage forms (tablets, capsules), liquid and semi-solid products, as well as aerosol and transdermal products. Contact us for more information.
  • Raw Materials Testing Services, Compendial

    Product Raw Materials Testing Services, Compendial

    Pace analytical life sciences llc offers wide range of services which includes raw materials testing service. It provides raw material testing services to the pharmaceutical, biopharmaceutical and medical device industries. It offer excipient testing to support usp/nf, ep, bp, jp, fcc and acs monograph testing requirements. It also test following client-supplied or vendor supplied methodology. The raw material testing supports formulation development within research and development, excipients and active pharmaceutical ingredients used in finished product manufacturing and supports the qualification. Contact us for more information.
  • Microbiology Testing Services

    Product Microbiology Testing Services

    Pace Analytical Life Sciences microbiology laboratory services support the pharmaceutical, biopharmaceutical and medical device industries. Testing is performed in compliance with current UPS/NF, EP, JP and client-supplied methodology. Custom protocols can be created to support product development, investigations, and unique testing needs. Microbiology testing services include:Microbial Limit Tests (Harmonized), Bacterial Endotoxins/LAL, Sterility Test, Particulate Matter in Injections, Biological Indicator Testing, Antimicrobial Effectiveness Test, Bioburden Testing, General Enumeration Testing, Microbial Identification, Water Testing, Clean Room/Controlled Environment Monitoring, Surface samples, Viable air particulates, Total air particulates, Compressed gases, On-Site Sampling, Client-collected samples, Disinfectant Efficacy Testing, Custom protocols.
  • Antimicrobial effectiveness test

    Product Antimicrobial effectiveness test

    Pace analytical life sciences llc offers wide range of services which includes antimicrobial effectiveness test service. It is performed to demonstrate if added preservatives, or the inherent antimicrobial properties of a product, are effective. This test is required for all multidose products and single dose products with added preservatives. It has methods in place that meet the requirements for the aet test and the recovery method suitability required by usp <51>. Contact us for more information.
  • Bioburden testing

    Product Bioburden testing

    Pace analytical life sciences llc offers wide range of services which includes bioburden testing service. It is done to determine the population of viable microorganisms in or on a pharmaceutical product, medical device or component prior to sterilization. It has methods in place to perform bioburden testing in accordance with iso 11737-1. It can also test according to client-defined methodology or according to usp <61><62> when appropriate. It has experience testing a wide variety of pharmaceutical dosage forms, medical devices and combination products. Its experienced microbiologists work directly with the client to determine the appropriate sample preparation/extraction procedures to ensure the bioburden test results meet the requirements. Contact us for more information.
  • Biological indicator testing

    Product Biological indicator testing

    Pace analytical life sciences llc offers wide range of services which includes biological indicator testing service. It provides testing, for the pharmaceutical, biopharmaceutical and medical device industries. The test, according to usp <55>, is designed to support: sterilization testing, sterilization validation, sterilization monitoring. Steam sterilization effectiveness, ethylene oxide (eo) sterilization effectiveness, sterility cycle lethality, lot release for compliance with testing requirements. The test consists of spore strips impregnated with several organisms’ spores. The biological indicators' viability is then an indication of the sterilization process effectiveness. Since spores are especially difficult to sterilize, their absence assures the process is validated and the testing is capable of providing accurate results. The number of strips used during the testing should be based on the usable chamber volume of the sterilizer or on the product load size. Contact us for more information.
  • Elemental metals / elemental impurities

    Product Elemental metals / elemental impurities

    Pace analytical life sciences llc offers wide range of services which includes elemental metals / elemental impurities service. It offers full-service gmp analytical laboratory capabilities for assessing levels of elemental metals / elemental impurities in raw materials, in-process formulations and finished pharmaceutical and medical device products. It provides analytical services to support compliance with quality control requirements whether monitoring label-claim or demonstrating control of trace-level elemental impurities. It has recently completed construction of a dedicated laboratory space for the testing of inorganic analytes including elemental metals, anions and cations. By dedicating laboratory space to this area of testing, is in-step with the upcoming and changing regulations and ready to help clients comply with more stringent testing requirements. Contact us for more information.
  • Endotoxin testing

    Product Endotoxin testing

    Pace analytical life sciences llc offers wide range of services which includes endotoxin testing service. It provides endotoxin testing for the pharmaceutical, biopharmaceutical and medical device industries. This test is also known as the limulus amebocyte lysate, or lal, test. It follow usp <85> bacterial endotoxins test and ep 2.6.14 as the methods to detect or quantify endotoxins that may be present in or on the sample. The test consists of two different techniques, the gel clot lal method and the photometric methods. Both techniques require preparatory testing to verify that the sample solution does not inhibit or enhance the detection of endotoxins. Its kinetic endotoxin laboratory personnel are highly trained in both techniques and laboratory procedures to ensure any test glassware or apparatus used is endotoxin free or non-pyrogenic. Contact us for more information.
  • Environmental monitoring services

    Product Environmental monitoring services

    Pace analytical life sciences llc offers wide range of services which includes environmental monitoring services service. It covers a range of areas requiring microbiological testing to detect changing trends of microbial counts and micro-flora growth within the manufacturing environments. In aseptic manufacturing the most challenging part of the process is producing a sterile product. The services cover sampling and testing in any controlled manufacturing environment from process water systems to compressed air and gas systems for pharmaceutical and medical devices. Contact us for more information.
  • Extractable and leachable testing

    Product Extractable and leachable testing

    Pace analytical life sciences llc offers wide range of services which includes extractable and leachable testing service. It has developed a comprehensive approach towards extractable and leachable testing. Its study identify extractables, compounds that can be extracted from a component under extreme conditions, and leachables, compounds that leach into a drug product from a component in direct contact with it under normal conditions. It may be composed of both organic substances and inorganic substances typically coming from plastic components, elastomers, coatings, accelerants, antioxidants, inks and vulcanizing agents. It is particularly relevant to pharmaceutical and medical device packaging where safety and packaging toxicology is being scrutinized. Testing is also important in the medical device industry when biocompatibility testing and material toxicology is being evaluated. Contact us for more information.
  • Facility validation support

    Product Facility validation support

    Pace analytical life sciences llc offers wide range of services which includes facility validation support service. It provides with a comprehensive range of analytical services to support the validation of pharmaceutical facilities. Its analytical testing services provide support for the validation of purified water systems, clean steam systems, compressed gases and clean rooms. It can help new facilities, perform on-going qualification services, as well as decommission existing facilities. All of this work is performed in strict compliance to cgmp requirements following usp, ep, jp, iso requirements. Contact us for more information.
  • Method development and validation

    Product Method development and validation

    Pace analytical life sciences llc offers wide range of services which includes method development and validation service. It provides senior level, highly experienced scientists dedicated to performing method development and validation services. Areas of expertise include: stability-indicating assays / impurity profiles, drug release / dissolution / elution methods, residual solvents methods, elemental, impurities methods, specific and non-specific cleaning verification / validation methods. Contact us for more information.

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