Analysis and control

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

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

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

- 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

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

- 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

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

- 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)

- 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

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:

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.

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.

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

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

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

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

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

Sectors

PHYSICAL-CHEMICAL ANALYSIS

Control of physical-chemical parameters

Methods of analysis

Stability studies for cosmetic products

Chemical Analysis (Environmental)

Metal Analysis

Industrial Hygiene

Product Safety

Instrumental Techniques

MICROBIOLOGY

Manufacturing and control services for pharmaceutical products

Batch production

Manufacturing and analysis under contract

Active Pharmaceutical Ingredients Production

QUALITY CONSULTING

SCIENTIFIC AND TECHNICAL CONSULTANCY

OCCUPATIONAL SAFETY AND HEALTH/ENVIRONMENT

LEGAL AUDITING FOR OCCUPATIONAL RISK PREVENTION

Events

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