Chemical, Toxicology, Bio-degradability, GMP, REACH compliances

Welcome to Pertecnica Engineering: Your Trusted Partner in Product Certification for Chemical Excellence

At Pertecnica Engineering, we recognize the paramount importance of chemical safety and compliance in today’s global market. Our specialized product certification services cover a spectrum of crucial areas, including Chemical, Toxicology, Bio-degradability, GMP (Good Manufacturing Practice), and REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) compliances. Partner with us to ensure your products meet the highest standards for safety, environmental responsibility, and regulatory adherence.

Chemical Certification Services

Toxicology Testing

Understanding the potential health hazards of chemicals is paramount. Our toxicology testing services include:

• Acute Toxicity Testing: Assessing the immediate adverse effects of a single exposure to a substance.
• Chronic Toxicity Testing: Evaluating the long-term effects of repeated exposure to a substance.

Bio-degradability Certification

In an era of environmental consciousness, certifying the bio-degradability of your products is essential. Our services cover:

• Aerobic and Anaerobic Biodegradation Testing: Evaluating the product’s breakdown in different environmental conditions.

Compliance Certifications

GMP (Good Manufacturing Practice)

Ensuring your products are manufactured with the highest quality and safety standards. Our GMP certification services include:

• Facility Audits: Assessing manufacturing facilities to ensure compliance with GMP standards.
• Documentation Review: Verifying that manufacturing processes are adequately documented and meet regulatory requirements.

REACH Compliance

Navigating the complexities of chemical regulations in the European Union. Our REACH compliance services include:

• Chemical Safety Assessment: Assessing the risks and safety of chemicals throughout their lifecycle.
• Substance Registration: Assisting with the registration of substances with the European Chemicals Agency (ECHA).

• Chemical Standards:

  1. ISO 14001: Environmental Management Systems – Requirements with guidance for use
  2. ISO 14040: Environmental management – Life cycle assessment – Principles and framework

• Toxicology Standards:

  1. ISO 10993: Biological evaluation of medical devices
  2. OECD Guidelines for the Testing of Chemicals: Series of internationally accepted guidelines for testing chemicals for various purposes

• Bio-degradability Standards:

  1. ISO 14852: Determination of the ultimate aerobic biodegradability of plastic materials in soil
  2. ASTM D6400: Standard Specification for Labeling of Plastics Designed to be Aerobically Composted in Municipal or Industrial Facilities

• GMP Standards:

  1. ISO 22716: Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices
  2. FDA 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals

• REACH Compliance Standards:

  1. Regulation (EC) No 1907/2006: Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH)
  2. ISO 14001: Environmental Management Systems – Requirements with guidance for use (relevant for environmental aspects of chemical management)

Why Choose Pertecnica Engineering?

• Chemical Safety Experts: Our team comprises seasoned professionals with in-depth knowledge of chemical safety standards.
• Environmental Responsibility: We prioritize the bio-degradability of products to ensure a minimal environmental footprint.
• Global Compliance: Our services cover international standards, facilitating market access worldwide.
• Customized Solutions: Tailoring our certification services to meet the specific needs of your products and industry.

Ensure the chemical safety and environmental responsibility of your products with Pertecnica Engineering. Contact us today to discuss how our comprehensive certification services can enhance the marketability and reliability of your chemical products