Microbiological organisms can represent a potential health hazard. Unitec helps you to prevent the biological contamination or presence of undesirable micro-organisms such as Salmonella and E.coli to meet FDA, CPSC and OHSA guidelines and regulations.

• Microbial Enumeration test (USP , JP, BP Appendix XVI B2, EP Ch.2.6.12)

• Microbial Specified Microorganisms (USP , JP, BP Appendix XVI B1, EP Ch.2.6.13)

• Microbial Preservative Effectiveness (USP , JP, BP Appendix XVI C, EP Ch.5.1.3)

• Microbiology Test of Cosmetic ISO /TC 217, ISO 17516 and ISO 11930

• USP/EP/JP Harmonized Chapters <61> and <62>

• FDA Bacteriological Analytical Manual – Chapter 23- Microbiological Methods for Cosmetics

• PCPC (CTFA) Microbial Content (M-1) and Examination for S. aureus, E. coli, and Ps. aeruginosa (M-2)

• The International Harmonization of the Compendial Microbial Limits Tests including 1111 Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use

All tests are accredited and performed in compliance with the main technical standards as USP, EP, BP, JP and ISO.

When you need to verify the safety of cosmetic and children’s products, Unitec’s team of scientists, regulatory specialists and chemists perform a range of safety assessments and toxicity tests from acute through chronic toxicity, sensitivity substances and carcinogenicity studies.

• LHAMA

• Toxicology Risk Assessment

• Carcinogenicity assessment, evaluation of Material and Formulation

• Environmental Toxicology Risk Assessment

• Consultation of SDS and GHS labeling

• Product Label Review and Consultation

Unitec can help you navigate audits to review the efficiency of your operations and improve quality output. Our assessors and training consultants are formally trained with the qualification of either the certified lead assessors internationally. Our team will identify what regulations and criteria apply to your facility, and determine if personnel, setup and operation system are adhering to compliance procedures, requirements and corporate policies.

Other than the specific customized methodology, our assessment would strictly complies with the global assessment criteria and methodologies of of ISO 19011- Guidelines for auditing management systems, ISO 17021 – Conformity assessment & FDA Quality System Regulation Part 820.

Benefits of a Unitec Facility Audit

• Identify and correct compliance issues

• Build the facility's and people knowledge of compliance

• Improve facility safety and to help reduce facility's and personal liability and risk

• Enhance awareness and understanding of regulations and corporate requirements

• Demonstrate the facilitys commitment to compliance

• Improve efficiency and cost-effectiveness of the facility's compliance program

Auditing Standards

• CGMP, GMP, GMPC consultation and assessment

• International recognized social corporate compliance

• Production facility assessment

• Material control and integrity management

• FDA Facility Registration

• Quality assurance and technical audit

• Production capacity and capability assessment

• On-site witness 'inspection and tests

• On-site material and inventory scanning

Most state governments enforce additional standards and regulations beyond federal mandates. At Unitec, we can help you understand state laws and place your products through the required testing methodologies.

• California Proposition 65 (e.g. Lead, Phthalates, Cadmium, Flame Retardants, BPA, toluene etc.)

• Washington Children’s Safe Products Act, CHCC screening and reporting

• Illinois (410 Ilcs 45/) Lead Poisoning Prevention Act

• Formaldehyde (including Minnesota 325F.175 of HF458)

• Flame Retardant – TCEP, TDCPP, TDBPP, PBBs, TCPP (enforced laws in 13 states including New York, Maryland)

• Bisphenol A (enforced laws in 12 states including New York, Nevada, Maine)

Our testing and assessment services cover product safety and health laws of the following states:
Washington, California, Oregon, Minnesota, New York, Massachusetts, Connecticut, New Jersey, Pennsylvania, Illinois, Ohio, Iowa, Vermont, Maryland, Maine, Tennessee, Rhode Island, North Carolina, South Carolina, Delaware, West Virginia, Louisiana, Alaska

Whether it’s product performance, resource usage, scalability or reliability testing, Unitec can help you understand performance issues related to product design, structure and architecture of software.

Reliability Testing

Establish the benchmark for product usage such as environmental, durability and product lifecycle testing.

• ANSI FL1 Standard for Flashlight

• Aging and Life-time Test

• Low Temperature Test

• Environmental Impact Test

• Physical Impact Test

Performance Testing

Test the benchmark and quality standard set for the application.

• Waterproofing Test of IPX/The IP Code (Ingress Protection Rating)

• Customized Protocol

• Anti-corrosion

• Viscosity and Flow Rate Test

• PH Test

Unitec Laboratory Services has international accreditation of ISO 17025 through ANAB, the US.

We offer certification for child resistant packaging following the below international regulations for product containers used in cosmetics, drugs, supplements, personal care and antiseptic products, household chemicals, insecticide, e-cigarettes, cannabis and more.

Unitec Laboratory Services is accredited through ANAB in accordance with ISO 17025 to perform the following certifications for child resistant packaging:

The European Standard

• ISO 8317 - testing reclosable child resistant packaging.

• EN 862 - testing non-reclosable, non-pharmaceutical child resistant packaging.

• BS EN 14375 - testing non-reclosable, pharmaceutical child resistant packaging.

• Tobacco Products Directive (TPD) Standard

• ISO 28862:2018

The US and Canada Standard

• 16 CFR 1700 through 1702 - Poison Prevention Packaging Act

• 16 CFR 1700.20 - testing procedure for special packaging

• EPA Testing Requirements, PRN 96-2: Changes to Child-Resistant Packaging (CRP)

• FDA ENDS standard

• Canada Food and Drug Regultions CRC c.870 Section C01.002 and CAN/CSA-Z76.1-M90

• CAN/CSA-Z76.1-06 (R2016) - Child Resistant Packaging

• CAN/CSA Z76.2-00 - Child Non-reclosable Resistant Packages

• CAN/CSA-Z76.1-99 (R2003) - Child Reclosable Resistant Packages
  

Other than CR/CRP testing, Unitec provides the comprehensive labelling review on child-resistant packaging, cosmetics, household chemical, e-liquid and cannabis products for the particular state regulation and national law including CCCR, CLP, PPPA, FHSA etc.

Unitec is one of very few internationally recognized testing and independent assessment bodies accredited to test to the global testing protocols for child resistant packaging in the Asia Pacific region.