Commissioning and Validation of Pharmacy Cleanroom Facilities

1
Commissioning and Validation of Pharmacy
Cleanroom Facilities

• Steve Willis
• Pharmaceutical Business Development Manager
• Daw Technologies

2
Introduction

• Overview of approach
• User Requirement Specification
• Design Qualification
• Installation Qualification
• Operational Qualification Physical and
  Microbiological
• Process Validation
• Specific Problems relating to PFI

3
Overview

• Project must be managed formally from outset to
  maximise the chance of success
• By end user inclusive all disciplines
• Relevant Regulatory Body
• Early contact with potential providers

4
User Requirement Specification (URS)

• This drawn up by the end user detailing exactly
  what the requirements for the facility will.
• Must be as detailed as possible
• Room Data sheets detailing
• Room dimensions
• Construction materials
• Physical Parameters
• Equipment
• Occupancy levels

5
User Requirement Specification cont.

• The URS forms basis of the of the Design
  Qualification (DQ)
• This will in turn dictate how the facility will
  perform
• Even at this stage the commissioning of the
  facility is dictated and difficult to rectify
  later

6
Design Qualification (DQ)

• This can be considered the first stage of the
  validation of a new facility
• Provides documentary evidence complies with all
  parameters set out in URS and complies with cGMP
• Provides technical specification for all fabric
  and equipment to facilitate audit trail
• Details how physical parameters of facility will
  be attained and maintained e.g. temp, RAC etc

7
Design Qualification cont

• All information must be formally agreed by all
  parties
• Large pieces of equipment to be installed e.g.
  Autoclaves need to undergo Factory Acceptance
  Tests and Site Acceptance Tests must be performed
  by the supplier and all relevant data provided
• This activity usually occurs between DQ and IQ

8
Installation Qualification

• Documented demonstration that all systems and
  operations are installed correctly and interface
  with existing systems
• IQ is referenced back to DQ requirements
• Tends to be mainly M E
• Technical, Operational and Maintenance data must
  be supplied for all equipment and formally
  approved by all parties
• Review of (OQ) data may be required to verify
  results

9
Operational Qualification (OQ)

• Documented evidence that the facility meets all
  parameters detailed in the URS and DQ
• Complex activity usually performed by specialist
  provider.
• All testing should be witnessed by appropriate
  designated staff from the end user to ensure all
  tests are performed correctly

10
Operational Qualification Cont

• Tests routinely performed may include
• Room temperature and humidity tests. In use loads
  should be artificially achieved
• Room Pressure Differentials and calibration of
  gauges
• Room Air Change Rates
• Filter integrity tests
• Air flow Patterns
• Airborne particle counts
• Particle decay rates

11
Operational Qualification Cont

• Issues to be wary of
• Particle counts are performed in the unmanned
• All equipment has current calibration
  certificates
• Documentation routinely provided is acceptable to
  the MHRA
• All equipment is in use e.g. isolators

12
Operational Qualification Cont

• Microbiological validation follows
• Usually performed by end user in the unmanned
  state in first instance
• Fully documented plan must be in place detailing
  information such as
• Tests to be performed
• Duration and frequency of tests
• Acceptance criteria
• Exception report and action plan
• Responsibilities of staff

13
Operational Qualification Cont

• After completion all OQ documentation should be
  collated including that for equipment e.g.
  isolators.
• Formal approval must documented by approved
  personnel

14
Summary

• Control must be exerted from the beginning to
  assure greatest chance of success
• The MHRA will go through all documentation from
  URS to OQ, PQ and Process Validation in great
  detail during 1st inspection
• This is of particular importance when involved
  with PFI
• Pharmacy staff may find it difficult to have
  input in the early stages

15
Summary Cont

• Dealing with main contractors who may have little
  or no experience of pharmaceutical projects
• They are working on very tight profit margins
• They may subcontract the project to the several
  different general contractors on site