NARD Institute technical keywords

Contract manufacturing

NARD Chemicals,ltd.

NARD Chemicals,ltd. With its system of high-quality assurance, NARD Chemicals has the flexibility to offer an optimal response over a wide range of contract manufacturing scenarios, from initial development to final product.

·Specialization in job-shop manufacturing: small quantities of many products
·Utilization of each employee's high technical expertise
·Quality assurance that lives up to your expectations (GMP, ISO9001)

Reaction Examples

We have the experience and equipment to handle a wide variety of reactions.

Low-/high-temperature reactions, water sensitive reactions

Below -100℃, reactions possible up to 400 L
Above 200℃, reactions possible up to 500 L

Applicable Reactions (example)

·Organic lithiation
·Inhibited decomposition of unstable intermediates
·Grignard reaction, etc. (activation of organometallic reagents)
·LiAlH4, Et3Al, etc. (flammable and pyrophoric reagents)

Handling odorous reagents

Extraction systems for odor management of sulfur-based reagents

Applicable Reactions (example)

·Swern reaction, etc. (odorous reactions)
·Use of various thiols

Oxygen sensitive reactions

By controlling oxygen contamination, we deliver reliable results for sensitive reactions.

Applicable Reactions (example)

·Oxygen concentration management for Pd(0) catalyzed reactions
(Suzuki, Negishi coupling, etc.)

Safety checks for potential risks

The risk of thermal runaway, explosion, etc. is evaluated in advance to determine feasibility.

Applicable Reactions (example)

·Use of peroxides in oxidation reactions, etc.
·Management of polymerizations

Oxygen sensitive reactions

Nucleophilic substitution and addition of nitrile anions under basic conditions

Production Facilities

With a small trial reactor, test runs of plant-production are performed.
Reproducing laboratory conditions as closely as possible, the reactions are scaled up.

Reactor (up to 400 L)

Reactor p to 400 L

·Modular reaction vessel
·Highly flexible reactions equipment
·Variety of stirring blades
·Simple cleanup
·Wide range of reaction temperatures (-100 –+250℃)

Reactor (over 500 L)

Reactor over 500 L

·Standard plant-production equipment
·Glass-lined and SUS equipment
·Suitable for high-pressure hydrogenation

SUS Reactors

Up to 400 L:

400, 260, 200, 100, 30 L (total: 11)
Suitable temperature:–100 –+250℃

Over 500 L:

1600 (max. 9.9 atm), 1500, 500 L (total: 4)
Suitable temperature: -15 –+120℃

Glass-lined Reactors

Up to 200 L:

200, 100, 50 L (total: 13)
Suitable temperature: -40 –+200℃

Over 500 L:

3000, 1500, 1000, 500 L (total: 8)
Suitable temperature: -5 –+120℃

Reactors

Other Equipment

Chromatography Equipment:

Chromatography Equipment:

50, 100, 200, 260 L columns
SUS with visualization slit
Temperature control jacket
Pressurized flushing possible
Many gels available
(various silica gels, ODS, adsorption resins, etc.)

Usage Examples:

·Precision preparative purification
·Desalting and purification by ion exchange and adsorption gels
·In cases where development-stage column chromatography cannot be avoided

Concentration Equipment

Concentration Equipment

100L 100 L evaporator (explosion-proof) x4
Capable of drying up to 30 kg

Usage Examples:

·Viscous oil isolation
·Dry product crystal isolation

Thin-film evaporation equipment

Thin-film evaporation equipment

Used for concentration of heat-sensitive materials

Application Examples:

·Concentration of fermentation products
·Processing extracts of natural products, herbal medicines, etc.
·Concentration of samples for food product development
·Other thermally unstable materials

Capacity:

Concentration capacity: 200 L / h (aq. solution)
                                 Heater contact time: 1 sec

GMP Compliance

Cleanroom

Class 10000 managed
Glass-lined filtration machine
Glass-lined reactors (100, 200 L)
Jet pulverizer
SUS-shelving vacuum desiccator (5.5 m2)

Clean booth

Class 100k managed
Clean space for use with general equipment(16 m2)
e.g. 400 L reactor, portable centrifuge, etc.

GMP Compliance

Analysis Equipment

Process Management

Production Department:

HPLC x10, GC x3

Technical Department:

HPLC x9 (two units with integrated PDA detector), LC/MS x1, GC x3

Quality Assessment

Quality Control Department:

HPLC (UV, PDA, RI, GPC), GC (FID)
Karl Fischer titrator (volumetric, coulometric), IR spectrometer, UV-Vis spectrometer, polarimeter, autotitrator, particle-size distribution analyzer, atmospheric control system

Process Development Service

Development of synthetic procedures that may be rapidly adapted from laboratory application to plant production.

Process Development Service

Examples of Implementation

·Development of GMP-compliant production processes
·Optimization of parameters and verification of threshold values
·Proposals of new production methods for mass-production

·Process safety verification
·Investigation and validation of reasonable manufacturing costs

As well as the product sample, a detailed study of the manufacturing process is also included with the final report.

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