Contamination Control Audits - Assessment of Existing Operations

Audit of procedures and protocols

Gowning, cleaning, & operating SOPS

Contamination audits - airborne & liquid particle counts, visible vapors, placement of supply & returns, UV light inspection, settle wafers (1246D fallout levels), NVR testing, airborne molecular contamination, microbial testing, etc.

Product handling audits

Cleanroom performance audits

Identify and correct cross-contamination caused by "lean" manufacturing principles

Mock cGMP audits, incl. people, product, material, waste, component flow and directionality of air flow



New Cleanroom Product Introductions

Product Development (Stage/Gate process), Launch & Management, incl. value-engineering

Marketing Communications Program Development incl. Media, P.R., Direct Response Programs, Literature/Collateral & Architectural Specifications

Product Sales Presentations and Distributor Training

Author technical articles & case histories and arrange for premier placement in industry journals

Product testing (particulate, molecular, microbial, etc.) and certification for cleanroom suitability



Project Planning & Basis of Design

Owner Representative and Project Management Services

"Make vs. Buy" Analysis & Identification of Qualified Outsourcing alternatives for cGMP production

Conceptual Design Development incl. barrier isolation technology

Third Party Design Reviews

Vendor/contractor identification & qualification

RFP/RFQ preparation

Scope definition

Bid tabulations

Selection and Contract award

Project management & critical path scheduling

Independent third party design reviews

Design/construction contract claims arbitration

Assessment & Valuation of existing cleanrooms



Cleanroom Conceptual Designs

cGMP floorplan & general equipment arrangement

Sized major process equipment lists

Functionality flow diagrams

HVAC zoning & room classifications

Budget quality cost screening estimates

Scope of Work Matrices

Gantt charting

ESD (electrostatics) criteria

Identification of Regulatory issues



Cleanroom Applications Engineering

Product/component selections and compatibility determination

Sizing, specifying, costing & value engineering

Vendor liason, Owner or contractor representation

Tooling compatibility assessments

Troubleshooting and corrective actions for FDA validation

Cleanroom engineering services are available for extended periods with service contracts.


Process Isolation & Mini-Environments

Enclosure design and specification

HVAC design and specification

Cleanroom re-design for cross-contamination control and implementation of isolation

Designs for Barrier isolation technology - positive pressure or containment

cGMP design reviews

Prototyping



Industrial Sales & Marketing

Business Planning & Strategy, M&A advice

Marketing Planning (Strategy, Positioning, Pricing, Forecasting & Budgeting)

Market Opportunity Analysis and Market Research (incl. Conjoint Analysis)

Sales Distribution Channel Development & Management

Trade Show and Trade Organization Activities & Promotions

High-Level "Key Account" Decision-Maker Identification and Sales Calls to influential, key cleanroom specifiers, contractors, and owners

Lead generation, qualification, and follow-up

e-commerce design and implementation incl. product support

Sales management consultation



Construction Claims Arbitration

Contract, Design documents, specifications and submittals review

Written arbitration opinions

Market Research & preparation of Exhibits

Expert Witness testimony