ISO 13485:For Medical devices – Quality management systems
ISO 11137:Gamma sterilization (Sterile R)
ISO 24988:Petrdish standards
ISO 8655:Accuracy Standards
ISO 6706:Accuracy Standards
DIN 12681:Accuracy Standards
NABL:Graduation Measurement Certification
ISO14001:Environment Management System
GC/MS (Gas chromatography Mass Spectrophotometry Test) Free
635 mm/Hg:Leak Test
95 kpa pressure test:for Storage vial.
Certification -How Valuable Are These
ISO 9001 : Quality Management System
Celebrating 10 years of ISO 9001
ISO 9001:2015 specifies requirements for a quality management system :
A) ABDOS demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.
B) ABDOS aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
Celebrating 10 years of CE
A) ABDOS is authorized CE on its products in trade movement in the European Economic Area.
B) ABDOS Conformity with Europe, demonstrate that the products have been audited/assessed in terms of minimum safety, health and environmental requirements.
C) ABDOS CE marking also indicates fair competition among manufacturers as it enforces accountability and conformity with the same requirements.
C) Whether used alone or in combination, intended to used in vitro for the examination of specimen, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
• concerning a physiological of pathological state of health or disease, or
• concerning a congenital abnormality, or
• to determine the safety and compatibility with potential recipients, or
• to monitor therapeutic measures.
ABDOS Cryo vials , Sample containers, & Storage vials ranges are IVD certified
1. ABDOSis strongly delivering IVDs certified products. IVDs certified & accessories used to perform tests on samples, such as blood, urine, tissue, taken away from the human body to help detect infection, diagnose a medical condition, prevent disease or monitor drug therapies.
2.The first step is to determine if the product is a medical device as defined by the Directive. The In Vitro Device Directive Article 1, point 2b defines an IVD as any medical device which is a
- Cryo product, containers & Storage, Instrument, Apparatus
- Reagent, Reagent Product Calibrator, Control Material
- Equipment, System
ISO 14001 : 2015 Environment Management System
ABDOS Labtech Achieves ISO 14001:2015 Environmental management systems Certification.
A) Based on ISO 14001:2015 specifies the requirements for an environmental management system,ABDOS is committed to enhance its environmental performance.
B) ABDOS is intended to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability.
C) ISO 14001:2015 helps organization achieve the intended outcomes of its environmental management system, which provide value for the environment Sustainability. ABDOS aims to deliver Consistent environmental policy, the intended outcomes of an environmental management system include:
- Enhancement of environmental performance;
- Fulfilment of compliance obligations;
- Achievement of environmental objectives.
ISO 13485 : Quality Management System
Celebrating 10 years of ISO 13485
A) ABDOS accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.
B) ABDOS is committed in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).
ISO 13485:2016 specifies requirements for a quality management system , ABDOS demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
C) ABDOS is committed to empower 5 clauses of ISO 13485 that are numbered 4, 5, 6, 7, 8
4.Quality management system
7.Product /service realization
8.Measurement, analysis and improvement
A milestone in testing and quality validation
DNase RNase & Pyrogen Free
Celebrating 10 years of DNase , Rnase free authentication
A) ABDOSConfirm that all essential range is “DNase/RNase-free”. It can be used for the sensitive applications such as PCR & qPCR.
B) DNase and RNase are ubiquitous in the environment, and in some biological materials. They are present in relatively high concentrations. RNase frequently
DNase degrades DNA and its presence is a threat to many molecular biology experiments.
- A deoxy ribonuclease, or DNase, is an enzyme degrades DNA by catalysing the hydrolytic cleavage of phosphodiester linkages in the DNA backbone.
- DNase contamination can come from contact with human skin, and is often present in the lab environment.
- DNase contamination is of great concern in the medical device and pharmaceutical industries as well as the biotech and research fields, because DNase can cause degradation of valuable DNA samples, which may make it impossible to analyse the DNA via PCR, QPCR or next generation sequencing
Endotoxin And ATP Free Test Report
ABDOS achieved Endotoxin level ≤0.03 EU/ml & Aiming for 0.005 EU/ml .
A). ABDOS achieved the endotoxin level ≤0.03 EU/ml & met the criteria established in ANSI/AAMI ST 72, IP & USP, Bacterial Endotoxins – Test methodologies, routine monitoring & alternatives to batch testing. The acceptance level for product is ≤0.03 EU/ml by LAL test.
B) Endotoxins are bacterial structural components that are released when such a cell is lysed.
• These components are toxic if administered to humans and/or animals, causing a pyrogenic response (rise in body temperature). For this reason it is important it must be tested for their endotoxin content. ABDOS provides endotoxin free products in Liquid , Centrifuge , Cryo & General laboratory category.
Gamma Sterilization : ISO 11137
A) Gamma radiation sterilization is the most popular form of radiation sterilization. Gamma based radiation sterilization has been deemed safe and effective by a number of government and public health agencies including the US Centre for Disease Control and Prevention, the Food and Agriculture Organization, the United Nations and the World Health Organization.
• Gamma rays pass readily through plastics and kill bacteria by breaking the covalent bonds of bacterial DNA.
• They are measured in units called kiloGrays (kGy). (ABDOS kGy is most ideal )
• Gamma irradiation provides a number of benefits in cost and sterility assurance. It can be applied under safe, well defined, and controlled operating parameters, and is not a heat- or moisture generating process.
• Environmental friendly: There is no residual radioactivity after irradiation.
Gamma Radiation dose is validated according to IS. EN. ISO 11137-2 Method 1 to confirm the SAL 10-6. For that routine testing of bioburden & Sterility test carried out at our manufacturing facility.
VALIDITY OF STERILITY
We assure all sterile products have been sterile through Co-60 gamma radiation withvalid certified dose and has been PASSED for all sterility tests. We confirm that the Sterile product would be Sterile until unless the packing pouch is not tampered/punctured/open or 5 yrs from date of Radiation.
Heavy Metal Test Report
A). ABDOS recommends Heavy metal free products. Presence of HM is less than 1PPM(not detectable). The sum of the incidental concentration levels of lead, mercury, cadmium and hexavalent chromium present does not exceed define limit of Coalition of Northeastern Governors (EU CONEG) model Toxics in Packaging Legislation.
B) ABDOS products can be used for storage and analysis tasks that require extremely low levels of most common metals.
ISO 18385 : Forensic DNA grade
A. ISO 18385:2016 directives are for requirements for the production of products used in the collection, storage, and analysis of biological material for forensic DNA purposes.
B. The consumables covered under ISO 18385 includes those used for evidence collection (sampling kits), such as swabs, containers, and packaging, and also products used in the analysis of DNA samples, such as Centrifuge tubes , Pipette tips, Cryo Vials and other plasticware, disposable laboratory coats, gloves, and other consumables.
C. ISO 18385:2016 applies to the production of consumables and reagents which do not require cleaning for continued use. This International Standard does not cover technical product specifications (i.e. product design).
D.ISO 18385:2016 specifies a requirement for manufacturers to minimize the risk of occurrence of detectable human nuclear DNA contamination in products used by the global forensic community.
E. Abdos range of products confirms ISO 18385: Forensic DNA grade for major product range.
GCMS/TOC test report
ABDOS CT, MCT , CRYO VIAL & RIA VIAL RANGE IS GC/MS CERTIFIED.
A). Gas chromatography/mass spectrometer (GC/MS) is a technique useful for detecting and measuring trace organic constituents in a bulk sample. In GC/MS , the components of a mixture are separated in the gas chromatograph (GC) and identified in the mass spectrometer..
B). GC/MS is the analysis method of choice for smaller and volatile molecules such as benzenes, alcohols and aromatics, and simple molecules such as steroids, fatty acids, and hormones. It can also be applied towards the study of liquid, gaseous and solid samples.
C) For next generation analysis GC/MS for compound analysis is imperative, including its ability to separate complex mixtures, to quantify analytes, and to determine trace levels of organic contamination.
D) ABDOS have validated GC/MS report with the guideline of BPOG.