Docstoc

Page 1 of 2 - DOC

Document Sample
Page 1 of 2 - DOC Powered By Docstoc
					SSI WIN COVETED SAACE GLENRAND MIB AWARD
- ENGINEERING EXCELLENCE – PROJECT VALUE LESS THAN R5-MILLION
FOR ENVIRONMENTAL CONTROL SYSTEMS FOR BIOVAC INSTITUTE
Congratulations to SSI’s project principal, Deryck Smith and his Cleanrooms team for winning the
―Engineering Excellence – Projects with a value of less than R5-million‖ – category at this year’s
CESA (formally SAACE) Glenrand MIB Awards, held at the Sandton Sun on 6 August.
Deryck entered the Biovac Institute Environmental Control project which beat off entries from other
consultants to take the coveted prize!
SSI also entered the Business Excellence, Projects with a value of more than R5-million (Marion
Island Research base) and Young Engineer categories.

THE PROJECT.
The Biovac Institute is a Public Private Partnership with the South African government through the
National Department of Health, created to develop a hi-tech infrastructure for vaccine research,
development and ultimately, production – the only company in sub-Saharan Africa to do so.
The Cleanroom Division of consulting engineering and project management group, SSI
successfully completed a design and site supervision contract for the environmental control
systems (air conditioning installations) for Biovac Institute’s new quality control laboratories in
Pinelands, Cape Town.
The new Biovac Quality Control (QC) facility was erected on the existing Biovac campus in
Pinelands. The existing buildings on the campus date back to the original State Vaccine Institute,
although some of these buildings have been upgraded over time. The new QC building is a vast
contrast to the existing Public Works style buildings and has brought the campus into the 21st
century. The new QC building is the first part of a long term plan for the complete site
development.

CLIENT BRIEF
The Biovac Institute needed to create a Quality Control laboratory that would comply with local and
international medicines regulatory GMP (Good Manufacturing Practices) requirements. This
entailed complying with the requirements of South Africa’s MCC (Medicines Control Council), and
international GMP guidelines, such as the EU Regulatory Agency, WHO Guidelines and the PIC/s
standards. Although the MCC was not a member of PIC/s at the time the facility was designed in
accordance with PIC/s standards. (South Africa has now become a member of PIC/s, the
Pharmaceutical Inspection Convention/ Pharmaceutical Inspection Co-operation Scheme, and as
such all new pharmaceutical and bio-technology manufacturing facilities and laboratories have to
comply with PIC/s requirements. After passing stringent entry requirements South Africa’s MCC
became a member of PIC/s in July 2007, becoming one of 33 member countries.)
The new facility was to contain all their new lab requirements as well as a two storey office
component linked to the labs. The offices were to face west to maximise the view of Table
Mountain.

SCOPE OF WORK
Deryck Smith, who is a Principal Specialist with SSI’s Industrial Sector and is the country’s leading
specialist in the design of cleanroom Environmental Control Systems (ECS) and mechanical
services, explained that the air handling systems at the Biovac Institute serve a number of different
areas in the facility.
―The systems have been designed to serve five different areas with different functions and
classifications, which refer to cleanroom classes and bio-safety protection levels,‖ he says.




                                                  1
The different zones are:
       general laboratories (Grade D and ISO Class 8 cleanroom classification)
       a sterile suite for carrying out sterility tests (Grade A and B or ISO Class 5 cleanroom
          classifications) The sterility tests are carried out under Unidirectional Airflow (previously
          called laminar flow) protection which is a Grade A condition, while the room background is
          a Grade B condition.
       a Bio-Safety Laboratory (Grade D cleanroom classification and Bio-Safety Level 3
          containment protection).
       a future cell culture laboratory (Grade B and C or ISO Class 5 and 7 cleanroom
          classifications).
       office air conditioning — a variable volume installation designed to meet comfort
          requirements only.
―A Cleanroom is an environment in which bacterial and particulate contamination is limited to
prescribed levels,‖ Smith explains. ―The Grades A, B, C and so on, refer to cleanroom
classifications as stipulated in the European Union Guide to Good Manufacturing Practice (GMP)
and the World Health Organisation (WHO) GMP Guide. The ISO Classes refer to the relatively new
ISO 14644 standards pertaining to the design, construction and testing of cleanrooms. This
standard is supplementary to the EU/EEC and WHO standards.‖
―A Grade A condition would typically be the cleanliness expected under an operating theatre
unidirectional airflow system (laminar flow theatre), while a Grade D condition is the cleanliness
level expected in a pharmaceutical tablet plant.‖ The relationship between the ISO Standards,
EEC Grades and bacterial limits for different classifications is given in the table below. All
cleanroom classifications relate to a number of dust particles of specific size per volume of air.
―A Bio-Safety Laboratory (BSL) is designed to contain hazardous substances, with emphasis on
preventing these substances from escaping into the atmosphere. These labs have various levels of
containment and are classified with protection levels from BSL 1 to BSL 4. The BSL 4 facilities are
those that handle the most hazardous products (such as hemorrhagic viruses), while BSL 1 labs
provide the lowest level of protection.‖
―These different levels of protection are defined by the Centre for Disease Control, in Atlanta, USA,
and the WHO, in Geneva. The Biovac BSL 3 lab is controlled at a negative pressure relative to
ambient to prevent any contaminants from escaping from the lab. All the air exhausted from the lab
is passed through High Efficiency Particulate Air (HEPA) filters to ensure that no contaminants are
liberated to atmosphere.‖
At the Biovac Institute, there are four central air handling units (plus one future unit) serving the
facility, each provided with chilled water as a cooling medium, from an air cooled chiller.

DESIGN CRITERIA
The laboratory areas were to comply with the various regulatory Classes as mentioned above.
However, the achievement of these classifications requires comprehensive design input. In the
cleanroom industry there is very little in the way of design guidelines as how to achieve the
required criteria. GMP standards are constantly evolving and becoming more stringent, but the
evolution of these standards is not necessarily by way of new guidelines. The new requirements
are generally as a result of what regulatory inspectors want and how they interpret the
requirements. New criteria also evolve based on a design concept adopted in a new facility, which
the inspectors then perceive as a new requirement. As a result it is imperative that the design
engineer keep close contact with the various regulatory authorities and also attend international
conferences to keep up with any new trends.
The Cleanrooms design engineers at SSI regularly attend international conferences on
pharmaceutical topics, and also present papers at various conferences. Deryck Smith has written
the GMP Guideline on Environmental Control Systems for the WHO, which is now available on the
WHO website. He has also written a WHO guideline for Environmental Control Systems for
Hormone Manufacturing Plants, which have specific requirements. The BSL 3 labs designed for
Biovac have very similar requirements to a hormone plant where the operators and the
environment need to be protected from hazardous substances.




                                                  2
Creating a clean environment is not achieved by simply adding high efficiency filters to the supply
air to the laboratories. The following factors all contribute to achieving the cleanroom environment,
and they all need to be in balance with one another in order to be effective:
      adequate air filtration to remove any contaminants from the supply air
      high air flushing rates relative to the Class required to dilute internally generated
         contaminants
      directional airflow to contain contaminants and prevent cross-contamination
      correct location of air terminals to ensure adequate air distribution
      correct sequence of air handling components to prevent re-contamination
      room pressure differentials between different rooms to ensure containment and prevent
         cross-contamination. (air typically flows from the cleanest rooms, maintained at a higher
         room pressure, to less clean rooms, at a lower pressure)
      attention to room layout – equipment positions relative to airflow directions
      room finishes – architectural finishes should not liberate particulate matter, should not be
         able to harbour bacteria and should be easy to clean.
      room structural integrity – room pressure differentials place additional design requirements
         on structural integrity.
      production activity – some production and test processes can liberate contaminants which
         need to be contained and extracted
      type of equipment in rooms which could disrupt airflow patterns
      number of staff – staff are one of the greatest sources of contamination in a cleanroom.
      staff discipline
      cleaning SOP’s
      staff flow
      raw materials flow
      temperature and humidity
Cleanrooms are costly installations and can cost anywhere between three and ten times the cost of
a conventional office air conditioning system. In order to achieve an efficient and cost effective
cleanroom, one has to optimise all the aforementioned factors, into an integrated facility.
The air conditioning system for a cleanroom is generally referred to as an Environmental Control
System (ECS) as it is far more complex than conventional air conditioning. The ECS is central to
the design of a facility such as this and architectural layout generally needs to be designed around
airflow, room pressure and containment requirements. For this reason cleanroom engineers
provide a lot of input into architectural layouts, building finishes and structural integrity.
Less complex, but still interesting, was the design of the office block air conditioning. The client
requirement was for a view of Table Mountain, however, this resulted in a west facing orientation
resulting in a conflict between view and sun control. In order to limit high heat loads from the
afternoon sun the architect devised a sun control façade which resembles a magnification of a
tissue sample. Some of the façade panels were left out to give better view of the mountain. The
sun penetrating the façade ―Swiss cheese‖ holes and the missing panels had to be calculated to
determine the sun load on the full height windows. A variable volume system was selected for the
office installation to reduce running costs and allow only sufficient air supply to match the changing
façade heat load.

INSTALLATION VALIDATION AND QUALIFICATION
The ECS of a pharmaceutical facility such as this, needs to be validated and qualified, which is a
regulatory requirement. Validation and Qualification is the process of proving and documenting
that the system performs as per the design specification and the Client’s User Requirement
Specification (URS). Only critical or ―Direct Impact‖ systems and components are qualified, i.e. the
items which could have an impact on test accuracy and product quality.
A risk assessment approach is used to determine the scope and extent of qualification. In-direct
Impact or non-critical components are not subject to qualification, but subject to GEP (Good
Engineering Practice) scrutiny. SSI worked together with Biovac’s qualification team to provide the


                                                  3
necessary test documentation. The OQ (Operational Qualification) report documentation prepared
by SSI in conjunction with the ECS contractor entailed the following aspects:

                   Air balancing
                   Room air change rate calculations
                   Room pressurization measurements
                   Filter integrity (DOP) testing of HEPA filters
                   Room particle count testing
                   Control system software functionality tests
                   Instrument calibrations
                   Room temperature monitoring
                   Room relative humidity monitoring
                   Maintenance procedures

The Operational Qualification process verified and documented that the systems operated within
the required limits and tolerances and that the systems complied with the design requirements.
The ISPE (International Society of Pharmaceutical Engineers), of which SSI is a member,
advocates the use of the V-diagram below. This indicates the ―Qualification approach to HVAC‖
(Heating Ventilation and Air Conditioning) systems, which indicates the checks and balances
between all qualification steps, to constantly ensure compliance at each step. As per GMP
requirements each step of the process must be completed and signed off before the next step can
proceed.




      A Qualification approach for HVAC Systems

           Model for “Direct Impact” systems

       User Requirement                       PQ Test Plan                           Performance

           (ie. What)                                                                Qualification



           Functional Design                  OQ Test Plan               Operational

         (ie. How as schematic)                 (inc.FAT)                Qualification

         Design
      Development                             IQ Test Plan   Installation
                           Detail Design
                        (ie. How to make)                    Qualification
                                                (inc.PDI)

                          Impact
                        Assessment
                                            Implementation
                                                                     ISPE Baseline Guide Vol.5




                                                    4
CLIENT COMMENT
Biovac’s CEO, Selwyn Kahanowitz, comments: ―This has been an impressive project. It ran under
budget and on time. The professional team, including Deryck Smith, displayed a very high
standard of professionalism, careful communication and cooperation throughout its duration. The
building makes a positive and bold statement and the laboratories are modern and spacious. On
the technical side, the service areas are well organised and finished to the very high level of detail
we demand. Anyone would be proud to take an auditor into this space.‖

SSI provides world class cleanroom capabilities to its client base throughout Africa, via a team fully
conversant in the unique requirements of engineering on this continent. These services
complement the offering of SSI’s parent company, DHV, which has a strong cleanroom division
operating in Europe and Asia.
The Cleanrooms division offers an in-depth knowledge of world class, local and international
HACCP (hazard analysis and critical control point) and GMP standards and local and international
regulations and requirements, as well as blue chip credentials in terms of qualifications and
expertise.

These credentials have attracted the attention of global organisations such as the WHO, who
requested Smith to prepare HVAC Guidelines relating to pharmaceutical facilities. Smith and his
team have also presented numerous workshops and assisted with the training of inspectors for the
WHO.

Consulting Team:

Principal Agents & Project Managers: LTS Consulting
Architects: Studiomas Architects & Urban Designers
Mechanical Consulting Engineers: DSCE Cleanroom Division of SSI – a DHV Company
Electrical Engineer: Mapule Consulting – Cape
Structural & Civil Engineers: Kwezi V3
Quantity Surveyors: Davis Langdon
Safety Consultant: Solid State Safety




                                                   5

				
DOCUMENT INFO