Pharmaceutical & Cosmetic Review May 2020

Page 34

FACILITIES MANAGEMENT & DESIGN

Design your facility with quality in mind In line with the principles of GMP, adequate consideration of facility design is key to enabling facility management. Dershana Valla of the CTFA expands on the design principles included in regulatory guidelines relevant to South Africa, to ensure quality and consistency in cosmetics manufacturing.

C

onsumers and regulators

operating in South Africa. This standard

is established, the design layout can

alike demand quality

provides, amongst other aspects, a

be planned.

cosmetic products that

good guideline to the physical design

promise innovation, efficacy

aspects of premises which facilitates

Hygiene and sanitation

and safety. There are many factors

the management of such facilities as a

It is imperative that the material used

that influence these attributes, yet few

defined and uniform practice.

for floors, walls, ceilings and windows

consider the factors behind the scenes, which are paramount to ensure product performance, safety and brand loyalty. Today we see and hear about world-

Materials and area management

in the production area are designed and constructed for ease of cleaning, sanitisation and to allow these to be kept

Prior to the design of a manufacturing

clean and in good repair. The surfaces

class production facilities, which house

facility, it’s imperative to consider the

should be smooth and resistant to

state-of-the-art and technologically

location and construction material that

potentially corrosive and harsh cleaning

advanced systems and ergonomic

will be used. These materials must be able

and sanitising agents. Windows should

designs, but these are only as good as

to be efficiently cleaned, sanitised and

be non-opening and if they are required

the premise of the principles that have

maintained while ensuring the protection

to be opened for ventilation reasons,

been consulted and implemented during

of finished products. There should also

they should be adequately screened to

the design stage. The principles of good

be clear separation of the various

prevent foreign material and pests from

manufacturing practices, or GMP, are a

activities that make up the elements of

entering the facility. Adequate lighting

good example.

the production process, taking place in

is important to enable operations within

designated areas.

the facility. However, lighting should be

The South African Bureau of Standards (SABS) has adopted the international

Sufficient space and separation of

standard ISO 22716:2007 first edition,

spaces is key to follow the principles of

SANS 22716:2017 Cosmetics – Good

GMP. These areas include a receiving

Manufacturing Practices (GMP) – Guideline

area, storage areas for raw materials and

be suspended from or supported by

on Good Manufacturing Practices.

packaging materials, sampling areas,

brackets to allow thorough cleaning.

Cosmetic, Toiletry and Fragrance

production areas, an area for quality

Drains must be kept clean and should

designed and installed to contain debris from potential breakages. Overhead pipework and ducts should

CTFA continues to promote the need for cosmetics manufacturing facilities to follow the principles of the GMP standard SANS 22716:2011

be designed to prevent backflow. In raw

Association of South Africa (CTFA) has

control testing, storage areas for bulk

system works by ensuring simultaneous

promoted this standard as best practice

and finished goods, a quarantine area,

opening and closing of interleading

within the self-regulated environment.

washing area, an equipment holding area,

doors, so that the doors are never open

The intent of the Department of

and washing and toilet facilities etc. These

at the same time. This will prevent pests

Health (DoH) to reform the industry by

are dependent on the product being

and other contaminants from entering the

publishing draft Regulations relating to

manufactured and the complexity of the

storage area.

Labelling, Advertising and Composition

processing and supply chain process.

of Cosmetics, R. 1469, 22 December

Once the space is defined, the design

material and packaging receiving areas where the opening and closing of doors is inherent to the activity and process, a dual-door system is recommended. This

Equipment design and cleaning

2017, confirmed the relevance and has

must consider the flow of processes and

Included in the design elements of a

mandated the principles of this standard

personnel through the facility, so that

manufacturing facility is the aspect of

for cosmetic manufacturing facilities

errors are prevented. Once this

equipment design, especially where

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| MAY 2020 | P C Review


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