EXPERT SERVICES

Our expertise covers the following pharma-engineering service fields:

Expert Services

1

Plant and facility design in compliance with GMP

• sterile/aseptic processes

• oral solid dosage forms

• semi-solid dosage forms

• liquids

• ointments

• nasal sprays

• APIs.

 

Our design executions include all process steps from formulation to finished products,

including specific processes such as freeze-drying

 

• conceptual design, basic design, detailed design, construction and qualification

2

Warehouse design, QC lab design (physico-chemical and microbiological), R&D lab design; all in compliance with GDP,GMP, and GLP

• conceptual design, basic design, detailed design, construction, qualification
3

Clean utilities: purified water (PW), water for injection (WFI), pure steam (PS), clean gasses

• conceptual design, basic design, detailed design, installation (including orbital welding), automation and qualification
4

HVAC

• conceptual design, basic design, detailed design, installation, qualification
5

BMS and EMS process automation

• conceptual design, basic design, detailed design, installation, qualification
6

Cleanroom systems

• conceptual design, basic design, detailed design, installation, qualification
7

Requirements and specifications: URS, FRS and SRS

8

On-site construction project management and start-up support

9

System commissioning

10

Consulting

• idea development, feasibility study, technical solutions, selection of equipment

• GMP, GLP, ISO, FDA and WHO guidelines

11

Qualification: IQ, OQ, PQ, DQ, RA, and master plan validation

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