HBW Solutions believes in providing our clients with CQV teams that consist of cross trained engineers who also have design experience. It is important that when our clients hire HBW, we provide them with a smart project team that has experience working together. This ensures that the facility production systems are qualified against appropriate standards and validated as efficiently as possible.
DELIVERING
VALIDATED
SYSTEMS
HBW Solutions can provide:
- Engineering Support Throughout Construction (Includes Monitoring of Mechanical and Electrical Systems During Construction and Issues Tracking/ Resolution, Passivation Planning/Monitoring, and Turnover Package Review)
- Automation Checkout and Operational Start-up Immediately Following Handover of Systems from Construction
- Systems Qualification Document Generation and Execution
- Operations Subject Matter Experts (Process, Cleaning, Sterilization, Utilities)
- Validation Master Planning
- Validation Document Generation and Execution
- Factory Acceptance Testing (Document Preparation and Execution)
- Site Acceptance Testing (Document Preparation and Execution)
- Quality Risk Assessments
Unit operation/
Process Parameter
Biological,
Chemical, Physical
Hazard
Description
Control
Measures
Control
Limits
Monitoring
System/Procedures
Dismantling of parts and accessories of the soiled equipment
B
C
P
Drying of product on the surfaces
of parts/equip
Engineering Controls
Quality Controls
Dirty Hold Times (TBD)
SOP, PCS, Change Management System
Biological contaminents parts and equipment on personnel clothing
SOP, PPE
N/A
SOP, Visual Inspection
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Damage to equipment during removal
Dropping of parts
onto the floor
SOP
JHA analysis
SOP, Visual Inspection
Item No.r
CIP Operational
qualification Testing
Acceptance
Criteria
Results
1.2.12
Confirm the EP_AIR_BLOW Phase initiates and
the following
Key Actions are performed:
- Client Tank device sequence is set to Air Blow Sequence.
EP_AIR_BLOW initiates and the following Actions Occur:
-
Client Tank device sequence is
set to Air Blow Sequence.
EP_AIR_BLOW initiates.
Client Tank device sequence is set to Air Blow Sequence
and the sequence and steps through in accordance with
the Client Tank Device Sequence Chart.
1.2.13
Confirm the EP_GRV_DRN Phase initiates and
the following Key Actions are performed:
-
Client Tank device sequence is set to Gravity
Drain Sequence.
EP_GRV_DRN initiates and the following Actions Occur:
-
Client Tank device sequence is
set to Gravity Drain Sequence.
EP_GRV_DRN initiates.
Client Tank device sequence is set to Gravity Drain
Sequence and the sequence steps through in
accordance with the Client Tank Device Sequence Chart.
1.2.14
Confirm the EP_AIR_DRY Phase initiates and the following Key Actions are performed:
- Client Tank device sequence is set to Air Dry Sequence.
EP_AIR_DRY initiates and the following Actions Occur:
-
Client Tank device sequence is
set to Air Dry Sequence.
EP_AIR_DRY initiates.
Client Tank device sequence is set to Air Dry Sequence
and the sequence steps through in accordance with the Client Tank Device Sequence Chart.