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As of March 7, 2024, LexaMed is actively recruiting for the following positions: Microbiologist, Lab technician, and Chemist.

ISO 17025 Accreditation Certificate

LexaMed’s ISO 17025 Accreditation Certificate has been updated on our Company Document page.  You may also download a copy of it here.

Renewed DEA Registration Form

LexaMed’s DEA Controlled Substance Registration Certificate has been updated on our Company Document  page.  You may also download a copy of it here.

ISO 13485 Certificate

ISO 13485 Certificate

LexaMed’s ISO 13485: 2016 Certificate has been updated on our Company Document  page.  

ISO 13485 Extension

Based on the current extraordinary events related to COVID-19, SIA Global has granted LexaMed with an extension of our current ISO 13485.  The expiration date is now March 31, 2022.  Please click here to download our extension letter for your records.  

Holiday Schedule

As 2021 comes to completion, we would like to thank all of our clients for the continued trust with all their needs.  We look forward to continuing meeting all of you needs in 2022 and beyond.  

LexaMed will be following the following schedule for the upcoming holidays.

Christmas:
LexaMed will be closed Thursday, December 23, 2021 at noon and closed all day Friday, December 24, 2021.  

New Years: 
LexaMed will be closed Friday, December 31, 2021.  We will return to normal operating hours (8:30am EST – 5:00 pm EST) on Monday, January 3, 2022.

Microbial Stability Study

MICROBIAL STABILITY STUDY (MSS) OF RECONSTITUED OR DILUTED DRUG PRODUCTS

Many sterile drug products require reconstitution or dilution prior to use which requires breaching the container closure system. Once a drug product’s container is breached, it is assumed that microbial contamination of the contents may have occurred. Manufacturers of non-preserved drugs, that will not be immediately administered to a patient, must demonstrate that the product will not support microbial growth during the labeled storage period under the stated storage conditions.

ICH Guideline Q8 (R2) Pharmaceutical Development states: “Where relevant, microbial challenge testing under testing conditions that, as far as possible, simulate patient use should be performed during development. Additionally, ICH Guideline Q1A (R2) Stability Testing of New Drug Substances and Products provides the following instruction: “Stability testing of the drug product after constitution or dilution, if applicable, should be conducted to provide information for the labeling on the preparation, storage condition, and in-use period of the constituted or diluted product. This testing should be performed on the constituted or diluted product through the proposed in-use period on primary batches as part of the formal stability studies at initial and final time points”

LexaMed performs Microbial Stability Studies (MSS) to evaluate the microbiological stability of drug products under specified storage conditions following reconstitution and/or dilution with specified diluents to demonstrate the product does not support microbial growth throughout storage in its end-use condition.

Protocol Development

Working closely with the study sponsor a LexaMed project manager will attain an understanding of the drug, diluents for preparation, storage conditions and storage time post reconstitution or dilution. Using this information, a protocol specific to the drug product will be generated. The study sponsor will be asked to review and approve the protocol prior to study initiation.

Study Outline

Test articles are reconstituted and/or diluted with diluents specified in the product labeling and then inoculated with ≤ 100 CFU/mL of the challenge organisms. Challenge organisms include strains listed in USP <51> and typical skin flora associated with nosocomial infection. The inoculated test articles are then stored at the storage conditions (temperature and duration) specified in the proposed label. A positive control prepared in the diluent solutions and a product negative control (without inoculation) are also included.

Test articles are stored for a period exceeding 2-3 times that of the maximum holding time in the proposed label with samples tested at periodic intermediate timepoints during storage to demonstrate that the diluted product does not support microbial growth for at least the maximum storage period under the specified storage conditions. At each sampling timepoint surviving viable microorganisms are enumerated using a qualified neutralization method. The change in log10 values of the microbial concentration at each timepoint are calculated and compared to the initial positive control concentration and expressed in terms of log10 change. A test article is considered to have microbial growth if the population is increased by more than 0.5 log10 units compared to the initial value measured.

If you would like to discuss your project with one of our experts, please fill out our contact form, and we will be with you immediately.

    Special Studies

    Controlled Environments

    Controlled Environments

    LexaMed is an industry leader for designing, testing, validating and monitoring your controlled environment.  We can help you fulfill  International Organization for Standardization (ISO), European Union (EU), and U.S. Food and Drug Administration (FDA) regimens. LexaMed provides a full range of best-in-class Environmental Monitoring Services which include experienced consultants to help with program development, trained microbiologists to conduct environmental monitoring sampling, use of calibrated sampling equipment and complete testing services.  

     

    Our all-inclusive environmental monitoring program includes development of an environmental monitoring master plan for your facility based on guidance provided in USP Chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments or ISO 14698 Cleanrooms and associated controlled environments – Biocontamination control.

    The plan will include outlining sampling site selection and rationale, alert and action limit setting, trending review requirements, investigation of over limits and how to qualify the program’s effectiveness. 

    For those clients who already have an environmental monitoring program in place we offer a plate supply and analysis-only program in which we provide quality control-tested media plates for your sampling use which can be returned for incubation and analysis by our trained staff.

    Our full range of environmental monitoring services include the following:

    • Industry recognized Consultants experienced in Controlled Environment Design and Monitoring
    • Performance of Active Viable and Non-viable Air and Passive Air Monitoring by trained Microbiologists
    • Performance of Viable Surface Monitoring – Contact Plates and Swabbing by trained Microbiologists
    • Rental of calibrated air samplers – viable and non-viable
    • USP <797> Gloved Finger-Tip Analysis
    • Personnel Monitoring
    • Personnel Support
    • In-Process Monitoring
    • Temperature and Humidity Monitoring
    • Water Sample Collection for Laboratory Analysis
    • Incubation, Analysis, and Reporting per USP <797> Specific Incubation Conditions
    • Isolate Characterization and Identification via Biolog™ phenotypic technology

    If you would like to discuss your project with one of our experts, please fill out our contact form, and we will be with you immediately.

      EO Sterilization Validations

      EO Sterilization Validations

      LexaMed has extensive knowledge and experience in all aspects of Ethylene Oxide (EO) Sterilization.  LexaMed consultants have served as co-chairs of the AAMI Sterilization Standards Committee Working Groups for Industrial Ethylene Oxide Sterilization (ST/WG 01), Biological Indicators (ST/WG 04) and Hospital EO Sterilizers (STWG 62) and remain as current members. 

      LexaMed can assist companies with all of the aspects of EO sterilization.   This included firms that currently have or are contemplating purchasing a 3M sterilizer, or companies that just want to utilize the unit’s capabilities for a specific project or requirement.   This support can include but is not limited to following services:

      • Consulting and Technical services
      • Determining most difficult to sterilize product/product location
      • Product & Process Development
      • Product and BI Comparative resistance studies
      • Product Cycle Validation (PQ)
      • Prototype or clinical sample sterilization
      • Material Compatibility
      • Cycle development
      • Packaging
      • BI and CI testing.  PCD development
      • Product Sterility Assurance Program
      • Product aeration characterization
      • EO Residuals

      If you would like to discuss your project with one of our experts, please fill out our contact form, and we will be with you immediately.