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The PharmaKo’s professionals are qualified to
perform multi-disciplinary engineering services, covering:
1. Basic Engineering
 Conceptual
and Basic Designs
Technical
and economical feasibility studies
2. Process Engineering
Process
Development
Process
Focused Plant Layout
Debottlenecking
studies
Batch and
Continuous Processing
Clean Design
and cGMP Compliance
Work Flow Optimization
3. Executive Engineering
Detailed
Design
Detailed
design on architecture, civil, piping, electrical, automation, HVAC
and other engineering disciplines..
4. Supply Chain and Procurement Services
Suppliers
selection
Duty book
preparation
Bid Process
Equipment
inspection
Test follow-up
5. Regulatory Agency Compliance
Process
Safety Studies (ANVISA requirements)
Fire Marshal
Compliance
Compliance
to the Requirements of Municipalities
ANVISA,
FDA, EPA, EMEA, ISO
6.Qualification & Validation
Preparation
of documents and protocols
Factory
& Site Acceptance Tests (FAT/SAT)
Design Qualification
(DQ), Installation Qualification (IQ), Operational Qualification (OQ),
Process Qualification (PQ)
Validation
on process and systems
7.Construction Management
Pre-qualification
of service suppliers
Bid process
package preparation
Proposal
equalization
Negotiation
and contract support
Construction
and erection supervision
Construction
and erection progress control
Payment
control (cash-flow)
Safety control
Cost control
Test supervision
Start-up
assistance
Hand over
procedures
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Rua Mário Enzio Pasqualucci, 300 - CEP 04711-090 - São Paulo - SP - Brazil |
Phone: (+55 11) 3467-8003 / Fax: (+55 11) 3467-6070 |
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