Located within the heart of New England we provide onsite cleanroom services through-out the region including the greater Albany area. Our industry experts on cleanroom services recognize the importance of a well-designed program that includes services such as water sampling, viable surface and air testing, particulate testing, and compressed air and gas testing. We work with you to identify your testing needs and establish a risk-based contamination control monitoring program. We have expertise in designing programs specific to manufacturing operations including:
- Aseptic Manufacturing
- Terminally Sterilized Medical Device
- Component Manufacturing
- API Manufacturing and others
Whether you’re looking for routine environmental monitoring or certifications and validations, we offer a wide variety of cleanroom services to ensure your needs are met, such as:
- Routine Environmental Monitoring
- Cleanroom Certifications
- Facility/Performance Qualifications
- In-situ Cleaning Studies
- Compressed Air / Gas Testing
- Water Sample Collection and Analysis
- Gowning Qualifications
- Cleanroom Program Evaluation / Risk Assessment
- Training and Consulting
Validating the cleaning steps of your drug product manufacturing process is a critical component of avoiding an adulterated product. Adulteration can occur if there is any remaining product or cleaning agent in the manufacturing line prior to the start of the next batch. In order to prove your cleaning process is effective, the validation of the process and subsequent monitoring are critical.
At Cambrex, we routinely help clients validate their cleaning processes by performing the following services:
- Method development and validation of analytical assays (HPLC, TOC)
- Performing swab recovery studies using the client’s swabbing instructions, drug product, and coupons of materials used in the manufacturing line
- Performing routine testing of post-cleaning samples (HPLC, TOC)
- Development of equipment specific cleaning validation protocols and reports
- Development of protocols and sample testing to support qualifying technicians in swabbing
- Performing viable and particulate focused cleaning studies
We utilize Total Organic Carbon (TOC) methodology as well as High Performance Liquid Chromatography (HPLC) in cleaning validation assays. TOC is a great method for cleaning validations because it is a non-specific method that will measure organic compounds. It is useful in cleaning validations because it is able to detect numerous compounds at very low limits in a single measurement. A drawback of TOC is that, because it is a non-specific method, the source of the measured result is not known. It must be assumed that all of the TOC measured is from a single source. This understanding is very important when a cleaning validation is performed, as multiple limits may need to be applied against a single measured TOC result. If a component in the drug product is of particular concern and its presence or absence needs to be known, a specific assay (such as HPLC) is recommended over the TOC assay.
We have the equipment and knowledgeable scientists available to help develop, validate and apply these methods for assessing your cleaning results.
ISO 14644 Cleanroom Certification
Our GMP-trained analysts provide cleanroom certification services, like HEPA Filter Integrity Testing and Room Recovery, with unmatched quality and integrity. Our CETA-Accredited Cleanroom Services Supervisor provides technical oversight of our program for full cleanroom qualification.
We offer a full range of ISO 14644 testing services for cleanroom certification and cleanroom qualification, including:
- ISO 14644-1 Cleanroom Certification by Particle Concentration
- Laminar Flow Hood Certification to manufacturer specification and certified to ISO 5 per request.
- Biological Safety Cabinet Certification to manufacturer and/or NSF specifications.
- Recommended Cleanroom Testing Services to include:
- HEPA Filter Integrity Testing
- Room Pressurization Measurements
- Airflow Volume / Velocity Profiling
- Calculated Room Air Exchange Rates
- Airflow Visualization Studies
- Room Recovery Studies
- Temperature and Humidity Monitoring
- Chemical Fume Hood Performance Verification
- Other cleanroom tests as per IEST, NEBB, or ISO
As well as this, we also offer Compressed Gas Monitoring to support your organization’s compliance with GMP regulations on cleanroom qualifications. Compressed gases within controlled environments are expected to meet the viable air and particulate levels of the controlled environments, and those considered to be a raw material that have direct and/or indirect product contact, should be subjected to a more rigorous testing and monitoring program.
Our experienced cleanroom certification services staff can assist with establishing the correct testing program and parameters based on your needs. Our testing capabilities include:
- Viable Air and Surface Monitoring (Aerobic and Anaerobic)
- Total Air Particulate Monitoring
- Compressed Air Viable and Total Air Particulate Monitoring
- Drager Analysis for Moisture, Hydrocarbon, Carbon Monoxide (Other indicators may be available upon request)
- USP Nitrogen Identity Testing (Flame and Odor Test)
- USP Nitrogen Content (GC Analysis)
- USP Oxygen Content (GC Analysis)
Cleanroom Services and Environmental Monitoring
We are the industry leader to test, validate and monitor your controlled environment! We are your cleanroom ally from start to finish. We can help you fulfill all International Organization for Standardization (ISO), European Union (EU), and U.S. Food and Drug Administration (FDA) regimens.
We offer an all-inclusive support service to provide ongoing, routine environmental monitoring for the intended purpose of the products being manufactured and the existing resources you have in place. Our total support service provides trained and gowning qualified analysts with scientific degrees, calibrated equipment, and quality control tested media, validated incubation methods, validated transportation of samples, analysis and reporting. Alternatively, we can provide trained staffing to supplement your existing environmental monitoring program during start-ups or qualification activities.
Our analyst can provide a number of environmental services, including USP <797> services, microbial identification through MicroSEQ (rapid 16S rDNA sequencing) and Vitek® (MALDI-TOF), or even temperature and humidity monitoring. In addition, we can provide quality control tested media for your use with a courier pick up upon request to ensure samples are put on test within 24 hours to minimize potential impact on recovery of organisms. Samples will be incubated within our validated chambers and analyzed by our trained microbiologists.
Finally, we have a plate analysis-only program in which we provide quality control-tested media for your use which can be returned for incubation and analysis by our trained staffing.
Water System Validation & Monitoring
Process water is the single most important raw material used in pharmaceutical and medical device manufacturing processes. We have been among the most experienced and capable laboratories for United States Pharmacopeia (USP) and European Pharmacopeia (EP) purified water testing. Our experts can also advise you on how to set up your pharmaceutical/medical device water testing programs and system validations to ensure they meet specific regulatory requirements. Our microbiology and analytical testing labs offer a wide range of methods for water analyses to support your validation and routine monitoring needs.
Purified water requires a specific panel of testing be performed as per USP and EP requirements. We are fully outfitted with state of the art equipment and highly trained experts to perform these tests in a timely and accurate manner ensuring the highest quality results.
The Cambrex purified water testing services include:
- Bioburden testing: used to establish the microbial load in water. Bioburden testing is offered using mHPC, R2A and mENDO agars offering a wider range of options to suit your specific needs.
- Conductivity testing: used to establish the sample’s ability to conduct electricity. This measurement relates to the number of dissolved salts (ions) in the sample, which can indicate a potential processing problem.
- Total Organic Carbon (TOC) testing: used to establish whether the level of carbon present in the sample is below the mandated limit. High TOC levels, which are above the mandated levels, are a reliable indicator of sample contamination.
- Heavy Metals and Nitrates testing: if your water also needs to meet EP requirements, Cambrex is fully equipped to perform Heavy Metals and Nitrates testing. These analyses are used to establish the level of metallic impurities and nitrates in the sample, both of which can lead to significant water quality problems.
If your water is being used for injection or internal applications, USP and EP requires that testing for endotoxins be added to the purified water testing panel. Endotoxin testing is designed to detect specific toxins (lipopolysaccharide) that are found as a structural component of the cell wall of Gram negative organisms. If these toxins are released from the cells, they can elicit a pyrogenic (fever) response in the patient. We are fully capable and experienced in performing endotoxin testing using various methodologies, including gel clot, chromogenic and turbidimetric methods.
USP <797> with MicroSEQ Temperature & Humidity Monitoring
We work with you to identify your USP <797> environmental monitoring with MicroSEQ microbial identification and other testing needs based on the use of your cleanrooms and critical utilities, the intended use of the products being manufactured and the existing resources in place. Current regulatory requirements specify that monitoring programs be established based on risk.
Full Range of Environmental Monitoring Services
We provide a full range of best-in-class Environmental Monitoring Services including:
- Active Viable Air Monitoring
- Passive Air Monitoring
- Viable Surface Monitoring – Contact Plates or Swab Methods
- Anaerobic Monitoring
- Absence of Specified Microorganisms USP/EP
- Total Air Particulate Monitoring
- USP <797> Specific Incubation Conditions
- USP <797> Gloved Finger-Tip Analysis
- Personnel Monitoring
- Personnel Support
- In-Process Monitoring
- Temperature and Humidity Monitoring
- Pressure Differential Monitoring
- Water Sample Collection for Laboratory Analysis
- Data Analysis and Trending Services
- Incubation, Analysis, and Reporting
- Isolate Characterization and Identification via MicroSeq or MALDI-TOF
Get in touch with Cambrex
If you’d like further information, don’t hesitate to contact us.