Analysis and control

 

PHYSICAL-CHEMICAL ANALYSIS

 

Control of physical-chemical parameters

  • Assay
  • Impurities
  • Residual solvents
  • Viscosity
  • Heavy metals
  • Humidity
  • Others required by the product specification

 

Methods of analysis

  • Start-up of physical-chemical analysis methods
  • Validation of analytical methods according to ICH guidelines.

 

Stability studies for cosmetic products

    • Protocol drafting for stability studies
    • Storage of samples in climatic chambers under ICH conditions
    • Analytical control
    • Drafting of stability study report.

 

Chemical Analysis (Environmental)

    • Chemical characterization of waste and drinking water
    • Analysis for specific contaminants in natural and waste waters both municipal and
    • industrial.
    • Analysis for contaminants in focal points of industries’ atmospheric emissions
    • Analysis for contaminants in soil and sediments

 

Metal Analysis

    • Atomic absorption –Flame - Hydride generation
    • Atomic absorption - Graphite

 

Industrial Hygiene

    • Environmental quality in the work place
    • Determination of chemical contaminants: solvents, metals, particles
    • Determination of physical contaminants: temperature, noise, vibration, radiation
    • Determination of biological contaminants: pathogens

 

Product Safety

    • Biodegradability test of commercial products according to official regulations (OECD, ISO)
    • Toxicity and ecotoxicity test
    • Metal content and toxic organic compounds content

 

Instrumental Techniques

    • Gas Chromatography flame ionization detector (GC-FID)
    • Gas Chromatography mass spectrometry (GC-MS)
    • Gas Chromatography, head space
    • HPLC, ultraviolet
    • HPLC, mass spectrometry
    • Atomic absorption spectrometry, flame-hydride generation
    • Atomic absorption spectrometry, graphite chamber
    • Infrared spectrometry, FT-IR
    • Molecular absorption spectrophotometry, UV-visible
    • Nuclear magnetic Resonance (400 MHz)

MICROBIOLOGY

    • Microbiological control of foods
    • Microbiological control of beverages
    • Microbiological control of packaged foods
    • Microbiological control of prepared meals, precooked meals, cold meals or sterile packaging.
    • Microbiological control of surface areas
    • Food handling control
    • HACCP evaluation
    • Evaluation of bactericidal and fungicidal activity of antiseptic and disinfectants according to ISO and UNE-
    • EN regulations.
    • Control of drinking water
    • Control of swimming water
    • Microbiological characterization of waste waters and drinking water
    • Microbiological control of raw materials and finished products
    • Validation of microbiological control methods
    • Challenge test
    • Microbiological assessment of vitamins (B12, biotin)
    • Bacterial endotoxins (LAL) in raw materials, finished products, purified waters and production water by the
    • Gel Clot method
    • Ames Test

MICROBIOLOGICAL CONTROL

  • Microbiological control of foods
  • Microbiological control of beverages
  • Microbiological control of packaged foods
  • Microbiological control of prepared meals, precooked meals, cold meals or sterile packaging.
  • Microbiological control of surface areas
  • Food handling control
  • HACCP evaluation
  • Evaluation of bactericidal and fungicidal activity of antiseptic and disinfectants according to ISO and UNE-EN regulations.
  • Control of drinking water
  • Control of swimming water
  • Microbiological characterization of waste waters and drinking water
  • Microbiological control of raw materials and finished products
  • Validation of microbiological control methods
  • Challenge test
  • Microbiological assessment of vitamins (B12, biotin)
  • Bacterial endotoxins (LAL) in raw materials, finished products, purified waters and production water by the Gel Clot method
  • Ames Test 

PHYSICOCHEMICAL CONTROLS

 

Control of physicochemical parameters

• Assay

• Impurities

• Residual solvents

• Viscosity

• Heavy metals

• Water content

• Others specified by the product

Methods of Analysis

•Start-up of physicochemical analysis methods

•Validation of methods for analysis according to ICH guidelines.  

Stability studies for cosmetic products

  • Protocol drafting for stability studies
  • Storage in climatic chambers under ICH conditions
  • Analytical control
  • Drafting of stability study report.

Chemical Analysis (Environmental)

  • Chemical characterization of waste and drinking water
  • Analysis for specific contaminants in natural and waste waters both municipal and industrial.
  • Analysis for contaminants in focal points of industries’ atmospheric emissions
  • Analysis for contaminants in soil and sediments 

Metal Analysis

• Atomic absorption –Flame

• Atomic absorption - Hydride

• Atomic absorption - Graphite

Industrial Hygiene

• Environmental quality in the work place

• Determination of chemical contaminants: solvents, metals, particles

• Determination of physical contaminants: temperature, noise, vibration, radiation

•Determination of biological contaminants: pathogens 

Product Safety

  • Biodegradability test of commercial products according to official regulations(OECD, ISO)
  • Toxicity and ecotoxicity test
  • Metal content and toxic organic compounds content

Instrumental Techniques

  • Gas Chromatography flame ionization detector (GC-FID)
  • Gas Chromatography mass spectrometry (GC-MS)
  • Gas Chromatography, head space
  • HPLC, ultraviolet
  • HPLC, mass spectrometry
  • Atomic absorption spectrometry, flame
  • Atomic absorption spectrometry, graphite chamber
  • Infrared spectrometry, FT-IR
  • Molecular absorption spectrophotometry, UV-visible
  • Nuclear magnetic Resonance (400 MHz)

 

 

 

 

 

PHARMACEUTICAL MANUFACTURING UNDER CONTRACT

Manufacturing and control services for pharmaceutical products

InKemia IUCT group is authorized by the Subdirección General de Inspección y Control de Medicamentos de la Agencia Española de Medicamentos y Productos Sanitarios as a medicine manufacturer (4155-E). For this purpose it counts with a manufacturing plant of approximately 200 m2 and control laboratories that allow for:

Batch production

The pharmaceutical pilot plant of InKemia IUCT group is suitable for the elaboration of non sterile liquid, semisolid and solid forms under a GMP environment. All this in a biobacth scale for clinical trials, stability studies and validation of industrial processes.

 

Manufacturing and analysis under contract

InKemia IUCT group offers their facilities and technical equipment at the service of companies so they can manufacture and analyze pharmaceutical products under contract, along with design and galenic development.

Active Pharmaceutical Ingredients Production

APIs production or pharmaceutical intermediaries by means of classical synthesis methods from grams to kilograms scale

APIs production or pharmaceutical intermediaries by means of fermentation and biocatalytic process in a scale from milliliters up to 5L

Consultancy

QUALITY CONSULTING

Assessment in the implementation of GMP in your organization

  • Manufacturing of API
  • Manufacturing of medicines

Assessment in the implementation of GLP in a chemical-pharmaceutical laboratory 

  • Research and development laboratories
  • Routine laboratories in pharmaceutical companies (GMP chapter 6)
  • Certified routine laboratories (ISO 17025) for biological and physicochemical tests

Assessment in the implementation of ISO 9000/2000

  • Physicochemical industry
  • Food industry

Assessment in the implementation of HACCP

  • Food industry
  • Catering
  • Food additives

 

SCIENTIFIC AND TECHNICAL CONSULTANCY

Our research and technological experience over the last years gives us the knowledge to asses in:

  • Patent Drafting
  • Drug Master File
  • Intellectual Property
  • Technical reports: competence, SWOT analysis, bibliographical research
  • Expert reports, scientific abstracts

 

OCCUPATIONAL SAFETY AND HEALTH/ENVIRONMENT

  • Environmental diagnosis and processing of grants
  • Auditing of the Environmental Management System
  • Environmental management and assessment
  • Evaluation of environmental risks
  • Processing of permits and resources
  • PDG and PGR execution
  • Assessment in environmental legislation
  • Waste management

 

LEGAL AUDITING FOR OCCUPATIONAL RISK PREVENTION

InKemia IUCT group has up to date accreditation (A-025-B) to perform audits of the occupational risk prevention system of companies.

 

The main areas in which the auditing by InKemia IUCT group is divided are:

  • Management of the occupational risk prevention system
  • Work safety
  • Work hygiene
  • Health monitoring
  • Applied ergonomics and psychology

The auditing of the occupational risk prevention system includes:

  • Documentation request
  • Study of the documentation
  • Visits to the work center
  • Conclusions and final report drafting

Applicable normative:

The execution of the prior described activities is based on the following legislation:

  • Law 31/95 of Occupational risk prevention
  • RD 39/97 of prevention services
  • Other legal documents derived from the previous lists
  • Procedures elaborated by the InKemia IUCT group.

INDUSTRIAL SAFETY

 

Occupational Safety and Health /Environment

•    Environmental diagnosis and processing of grants
•    Auditing of the Environmental Management System
•    Environmental management and assessment
•    Evaluation of environmental risks
•    Processing of permits and resources
•    PDG and PGR execution
•    Assessment in environmental legislation
•    Waste management

 

OCCUPATIONAL RISK PREVENTION

 

Legal auditing for occupational risk prevention

InKemia IUCT group has up to date accreditation (A-025-B) to perform audits of the occupational risk prevention system of companies.

The main areas in which the auditing by InKemia IUCT group is divided are:
•    Management of the occupational risk prevention system
•    Work safety
•    Work hygiene
•    Health monitoring
•    Applied ergonomics and psychology

The auditing of the occupational risk prevention system includes:
•    Documentation request
•    Study of the documentation
•    Visits to the work center
•    Conclusions and final report drafting

Applicable normative
•    The execution of the prior described activities is based on the following legislation:
•    Law 31/95 of Occupational risk prevention
•    RD 39/97 of prevention services
•    Other legal documents derived from the previous lists
•    Procedures elaborated by the InKemia IUCT group.

 

SCIENTIFIC AND TECHNICAL CONSULTING

 

Scientific and Technical Consulting

Our research and technological experience over the last years gives us the knowledge to asses in:
•    Patent Drafting
•    Drug Master File
•    Intellectual Property
•    Technical reports: competence, SWOT analysis, bibliographical research
•    Expert reports, scientific abstracts

 

 

QUALITY

Quality Consulting

Assessment in the implementation of GMP in your organization
o    Manufacturing of API
o    Manufacturing of medicines

Assessment in the implementation of GLP in a chemical-pharmaceutical laboratory  
o    Research and development laboratories
o    Routine laboratories in pharmaceutical companies (GMP chapter 6)
o    Certified routine laboratories (ISO 17025) for biological and physicochemical tests

Assessment in the implementation of ISO 900/2000
o    Physicochemical industry
o    Food industry

Assessment in the implementation of HACCP
o    Food industry
o    Catering
o    Food additives

Events

News

Contact

  •   info@inkemia.com
  •  +34 93 579 34 32
  •  +34 93 570 57 45
  •  C\ Àlvarez de Castro, 63, 08100
    Mollet del Vallès (Barcelona)