Sterilization of health-care products
Bioburden
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (EN ISO 11737-1)
Sterility (Sterility Assurance Level 10-6)
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (EN ISO 11737-2)
Pyrogen & Endotoxin tests
Rabbit pyrogen test
LAL endotoxin test
|
EN ISO 11135 |
Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (suitable for heat/radiation sensitive materials) |
|
|
Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
|
|
Radiation - Part 2: Establishing the sterilization dose |
|
|
Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
|
|
|
Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
|
|
|
Moist heat - Part 2: Guidance on the application of ISO 17665-1
|
|
|
Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
|
|
|
Biological indicators - Part 1: General requirements |
|
|
Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
|
|
Biological indicators - Part 3: Biological indicators for moist heat sterilization processes |
|
|
Source: |
|
Temperature and temperature/humidity data-loggers
PyroButton-TH
Intrinsically Safe. Sensor and electronics are housed in a 305 ss food grade housing (i.e., FDA approved for use in food processing) of 17
mm diameter and 6 mm height. It is the smallest data-logger on the market.
Self-powered temperature/humidity data-logger
Temperature (-20 to +85°C), ±0.0625°C resolution, ±0.3°C accuracy
Humidity (3.4 – 97.3% RH), resolution ± 0.04% RH, ±2% RH accuracy
Calibrated at 5-temperature points relative to NIST reference and 5-humidity points. Each measurement is corrected relative to the calibration curve.
Data integrity protection for 21 CFR Part 11 requirement.
Source: www.pyrobutton.com/products/dataloggers.asp
Parametric release of sterile products
Parametric release effectively shortens sterilization-cycle time and reduces work-in-process. When process-capability has been shown to remain well within defined specification limits, sterilization-validation documentation allow parametric release of medical devices, without 7 days waiting for growth of biological indicators.
Contact us to shorten your sterilization-cycle time, and/or to validate your sterilization processes according to applicable standards.
Dr. Hekmat CONSULTING
Interim Management & effective Consulting
Regulatory Affairs & Quality Management, Class III Medical Devices & Combination products
25+ years of effective Strategic & Operative expertise in Clinical & Regulatory Affairs plus Quality Management for Medical Devices industry. Market Access, within the medical fields of Arterial implants, Cardiology, open Heart & Vascular Surgery, Ophthalmology, Neuro-stimulation, Orthopedics, Dental Care, Modern Wound Care, Regional Anesthesia, Minimal Invasive Surgery, Navigated Robotic Surgery, OCT, CT & NMR digital Imaging (3D), and in vitro Diagnostics.
Technical Documentation (DHF, DMR, DHR), STED, including Analysis & Evaluation of Product Function & Safety, Biocompatibility, Packaging, Labeling (UDI), Sterilization, Laboratory results, Software & Hardware.
Compliance to applicable Standards (ISO, IEC, EN, MIL).
Certifications acc. current EN ISO 13485 Quality Management Systems,
GMP, GCP, GLP, GDP,
Manufacturing Process Verification, Validation (IQ, OQ, PQ).
Product & Production-process Risk Management from Design to market (Risk Analysis & Risk Control), including Additive Manufacturing.
Clinical Evaluation, Organization of global multicenter Clinical Studies.
Audits of Production Processes & Suppliers.
Medical Device Reporting to Competent Authorities (e.g. BfArM, FDA).
Corrective And Preventive Action (CAPA) / Non-Conformity (NC) / corrective Project.
On site Support in Notified Body audits, and FDA inspections.
Effective management leading to a multitude of marketing approvals in the EU, Americas (FDA), & Asia, including Reimbursement schemes.
Dr. Hekmat CONSULTING
https://www.hekmat-consulting.de/
VAT-ID / USt-ID: DE295239280
Tübingen, Germany (Stuttgart area)
DUNS number 313240073
Email:
hekmat(at)hekmat-consulting.de
secure email: A.Hekmat(at)protonmail.ch
Mobile: +49 170 8530715
Skype: anuschirawan.hekmat
Druckversion 