WO2018025126A1

WO2018025126A1 - A plant for producing cosmetic products, in particular for producing wet wipes

Info

Publication number: WO2018025126A1
Application number: PCT/IB2017/054528
Authority: WO
Inventors: Guerrino GNAGNARELLI; Giuseppe Marone
Original assignee: Fater S.P.A.
Priority date: 2016-08-05
Filing date: 2017-07-26
Publication date: 2018-02-08
Also published as: IT201600082954A1

Abstract

A plant for producing cosmetic products, in particular for producing wet wipes, comprising: - an isolation structure (18) installed inside a building (10) and having an internal environment (20) controlled in accordance with reference standards for producing cosmetic products, - an air treatment assembly (38) for filtering and sanitizing a flow of air introduced into the isolation structure (18), configured to maintain a positive pressure difference between said internal environment (20) and the external environment (12), - an apparatus for producing cosmetic products (22) and a primary packaging apparatus of the cosmetic products (24) installed inside the isolation structure (18), and - a secondary packaging apparatus (26) installed outside the isolation structure (18).

Description

"A plant for producing cosmetic products, in particular for producing wet wipes"

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TEXT OF THE DESCRIPTION

Field of the invention

The present invention relates to a plant for producing cosmetic products. The invention has been developed in particular for constructing plants for producing wet wipes, but it is understood that the invention is not limited to this particular sector and is applicable, in general, to plants for producing cosmetic products of various types.

Description of the prior art

The EC Regulation 1223_2009 "New Regulation for Cosmetic Products" published on 22 December 2009 in the Official Journal of the European Union aims to guarantee the safety of cosmetic products and to protect the health of consumers. Among the various aspects, EC Regulation 1223_2009 envisages that the activities of production and packaging of cosmetic products are carried out according to Good Manufacturing Practice (GMP) standards. The reference standard that describes the specific requirements of Good Manufacturing Practice (GMP) for the cosmetic industry is UNI EN ISO 22716_2008 "Cosmetics - Good Manufacturing Practice (GMP) - Good Manufacturing Practices Guidelines". This standard, specially designed for the cosmetic industry, provides guidelines for producing, controlling, preserving and shipping of cosmetic products. As of 11th July 2013, compliance with GMP requirements has become mandatory, and manufacturing companies of cosmetic products must demonstrate compliance with the EC Regulation 1223_2009 by adopting the harmonized standard EN ISO 22716_2008. In order to ensure compliance with this standard, manufacturing companies of cosmetic products are forced to adapt or build ad hoc buildings within which to install machines and equipment for producing and packaging cosmetic products. The construction or adaptation of buildings in accordance with the GMP regulations is a significant cost for companies intending to start a new production of cosmetic products, as well as a notable complexity regarding implementation and management of the project. Indeed, the construction and modification of buildings are subjected to various national and local standards, laws and regulations. Often, lengthy periods of time are required to obtain authorizations, opinions and the clearance needed to carry out the work of construction or modification of buildings.

Upon adaptation of the buildings, all production processes within the buildings are subject to the high standard prescribed by the GMP regulation, both processes that have an actual risk of microbiological contamination, and processes that do not present this risk, such as secondary packaging and/or storage of raw materials and finished products. The fact that the entire building is adapted to GMP standards is also a potential source of environmental contamination, given that within the building there are contamination factors that are inevitably difficult to control.

The production of aqueous solutions, such as lotions or other water-based solutions or mixtures, used in the process of producing cosmetics is usually carried out in separate and dedicated environments within the same building. These environments must, however, also meet the requirements imposed by the GMP standards. This forces manufacturers to equip other areas in accordance with GMP standards, as well as those strictly necessary for the production and packaging equipment, which entails a further increase in the costs of plant construction and management.

Object and summary of the invention

The present invention aims to provide a plant for producing cosmetic products that overcomes the problems of the prior art

In particular, the invention aims to provide a plant for producing cosmetic products that allows compliance with GMP regulations and standards without the need to modify the buildings and centralized plants of a manufacturing plant.

According to the present invention, this object is achieved by a plant having the characteristics forming the subject of claim 1.

As will be apparent from the following description, the plant according to the present invention allows the requirements of the EC Regulation 1223_2009 and the GMP UNI-ISO 22716_2008 standard to be met, within a standard industrial building that does not comply with these standards, such as buildings used for the producing consumer goods or processing intermediaries (diapers, textiles and non-woven fabrics, plastics, detergents, etc.), which are not subject to the application of specific GMPs, or they are subject to less restrictive GMP requirements, without the need to adapt the building structures and facilities .

An advantageous aspect of the present invention envisages a new system for preparing the raw materials needed for producing lotions and similar aqueous solutions, which allows the preparation of these aqueous solutions directly in the area dedicated to the preparation and packaging of the cosmetic products, without the need to equip separate areas for producing the lotions.

The claims form an integral part of the disclosure provided here in relation to the invention.

Brief description of the drawings

The present invention will now be described in detail with reference to the attached drawings, given purely by way of non-limiting example, wherein:

- Figure 1 is a schematic plan view of a building containing a plant according to the present invention,

- Figure 2 is a plan view of the plant indicated by the arrow II in Figure 1,

- Figure 3 is a schematic diagram (not to scale) illustrating the air treatment system indicated by the arrow III in Figure 2,

- Figure 4 is a cross-section along the line IV- IV of Figure 2 showing an entrance area for material and personnel in the plant of Figure 2,

- Figure 5 is a plan view of an area for preparing lotions indicated by the arrow V in Figure 2,

- Figure 6 is an elevational view according to the arrow VI of Figure 5,

- Figure 7 is a cross-section along the line VII- VII in Figure 2, and

- Figure 8 is a detail of the outlet area of the packages, indicated by the arrow VIII in Figure 2.

Detailed description

With reference to Figure 1, numeral 10 designates an industrial building having an internal volume 12 that does not comply with the standard UNI EN ISO 22716_2008, hereinafter indicated, in brief, by cosmetics GMP standard. Within the building 10, a plant 14 is installed for producing cosmetic products in compliance with the cosmetics GMP standard. Other plants 16 can be installed inside the building 10, which do not require compliance with the cosmetics GMP standard .

With reference to Figure 2, the plant 14 comprises an isolation structure 18 installed inside the building 10. The isolation structure 18 has an internal environment 20 controlled in compliance with the cosmetics GMP standard.

Inside the isolation structure 18, an apparatus is installed for producing cosmetic products 22 and a primary packaging apparatus 24. Outside the isolation structure 18, a secondary packaging apparatus 26 is installed. The primary packaging apparatus 24 forms the packaging that is in direct contact with the cosmetic products, and must therefore operate in compliance with the cosmetics GMP standards. The secondary packaging apparatus 26 packages the packages coming from the primary packaging apparatus into packs or boxes. The materials used in the secondary packaging apparatus 26 are not in direct contact with the cosmetic products. Therefore, the secondary packaging apparatus 26 can be located outside the isolation structure 18.

The plant 14 comprises a loading and pre-mixing area 28 of raw materials for preparing solutions, mixtures or aqueous emulsions, located inside the isolation structure 18, and a mixing and storage area 30 for storing solutions, mixtures or aqueous emulsions located outside the isolation structure 18. The storage area 30 comprises at least one tank 32 for mixing and storing solutions, mixtures or aqueous emulsions prepared in the loading and pre-mixing area 28.

The isolation structure 18 has a plurality of entrances 34 for the passage of raw materials and/or personnel, and an outlet section 36 for the exit of primary sealed packages. The isolation structure 18 is made of materials that enable the isolation of the internal environment 20 from the external environment 12. All the inner surfaces of the isolation structure 18 can be washed and sanitized by liquid or gaseous chemical agents. The isolation structure 18 can be equipped with transparent walls to allow the visibility of the apparatuses from the outside and the passage of light from outside the isolation structure 18. The isolation structure 18 can be installed directly in contact with the floor of the building 10, or could be provided with a raised floor with respect to the floor of the building 10.

With reference to Figures 2 and 3, the plant 14 comprises an air treatment assembly 38 for filtering and sanitizing the air introduced into the isolation structure 18. The air treatment assembly 38 is configured to maintain a positive pressure difference between the internal environment 20 and the external environment 12. The air treatment assembly 38 comprises a casing 40 having an air intake 42 that draws air from the external environment 12. The air flow is drawn by a fan 44. A filter system 46 is provided between the inlet 42 and the fan 44. Optionally, downstream of the filters 46, a conditioning module 48 and a UV irradiation module 50 can be provided. The air flow is sent inside the isolation structure 18 via a duct 52, possibly through a series of HEPA filters 54. A duct 56 draws a recirculation air flow from the internal environment 20 and sends the recirculation air flow to the inlet 42 of the treatment assembly 38. A flow control valve 58 and a HEPA 60 filter can be provided on the recirculation duct 56. The air treatment assembly 38 is controlled via pressure sensors, which provide information on the pressure inside and outside the isolation structure 18. The air treatment assembly 38 has the ability to modulate the air flow introduced into the isolation structure 18, so as to maintain a constant positive pressure difference between the internal environment 20 and the external environment 12. The UV irradiation module 50 may optionally be provided with modules that can be activated sequentially depending on the amount of air treated. The treatment assembly 38 can be interfaced with the equipment for producing cosmetic products 22 to stop the device 22 in the case of breakdown or failure to observe the process parameters established to ensure the pressure of the internal environment 20. The conditioning module 48 can be used to carry out heating/cooling and humidification/dehumidification of the air flow if the environment 12 in which the plant 14 is installed is not already provided with environmental conditioning systems or these do not provide the same environmental conditions required within the internal environment 20.

With reference to Figure 4, each entrance 34 can comprise an inlet section for material 62 and/or an entrance section for personnel 68. The inlet section for material 62 comprises a double door with shutters or roller blinds 64 with automatic alternate opening, and an intermediate chamber in which the materials 66 are positioned. The two doors 64 never open simultaneously and are controlled so that the outer doors can only be opened if the inner doors are closed, and vice versa, so that a pressure is established in the intermediate chamber that is intermediate between the pressure of the internal environment 20 and the pressure of the external environment 12. The intermediate chamber can be provided with a UV irradiation system or a cleaning system of the air of the chamber. The UV irradiation or cleaning system is activated with both doors closed at each entrance of material into the intermediate chamber. The UV irradiation and air-cleaning systems can be omitted in some low-risk contamination productions.

The entrance systems of the people 68 are made up of chambers with automatic or manually-opening double doors 70, with an intermediate chamber containing cabinets 72 for disposable clothing to be worn in the internal environment 20 and applicators of disinfectant solutions for personal hygiene.

With reference to Figures 5 and 6, the mixing area 28 located in the internal environment 20 can comprise a storage area 74 for the raw materials, scales 76, at least one mixing tank 78 and an emulsifier 80. In the example illustrated, two mixing tanks 78 are provided, consisting of small tanks equipped with agitators and vertical slots for loading solid raw materials (powders, salts, etc.) to be mixed with sanitized water. The mixtures prepared in the tanks 78 are sent via pumps 82 to the storage tanks 32 (Figure 7) located outside the isolation structure 18. The outer tanks 32 are provided with agitators and are closed because they do not require opening, in the normal manufacturing process, for checking the process and loading the materials. The outer tanks 32 have the upper part connected through an air intake pipe 84 to the internal environment 20 of the isolation structure 18. The aqueous solution contained in the outer tanks 32 is sent by means of pumps 86 and pipes 88 to the internal environment 20 to the apparatuses 22 for producing cosmetic products

With reference to Figures 5 and 6, in the mixing area 28, a suction hood 90 can be provided, located in the area dedicated to the opening and loading of the solid/liquid materials used for preparing aqueous solutions. The air flow coming from the suction hood 90 can be conveyed in special filters (EPA and activated carbon) located outside the isolation structure 18 and can be re-introduced into the environment 12 outside the isolation structure 18. Alternatively, the air flow coming from the hood 90 can be conveyed in other air treatment plants already present in the building. The connecting pipes between the hood 90 and the external filters can be equipped with valves for automatic closing when the hood is not active.

In one embodiment of the present invention, the plant 14 is intended for producing wet wipes. The packets of wet wipes are basically composed of three elements :

- a layer of absorbent, synthetic or natural fabric, cut into sheets,

a mixture or aqueous emulsion of various detergent, emollient, preservative components etc., commonly referred to as "lotion", which imbues the substrate, and

- a primary packaging that hermetically seals a pack of lotion-imbued sheets.

Within the isolation structure 18, all the processing steps for producing packages of wipes take place up to the closure of the primary packaging in direct contact with the wipes.

The reels of absorbent fabric are deposited by external transport systems into the intermediate chamber of an inlet section 62. An operator working outside the isolation structure 18 removes the reels of rolls that have been exposed to the external environment during the various steps of transport and storage from the producer to the user, and are therefore contaminated. Then, the operator places the reels of substrate into the entrance chamber. The operator exits and activates a sanitizing process by UV irradiation or air-cleaning, if provided, with both doors of the entrance section closed. At the end of the process, the inner door opens and an operator collects the material from the inside and loads it onto the unwinders of the apparatus 22. The fabric that is unwound from the reels reaches the former or converter and is folded and layered. The fabric is soaked with the aqueous solution (lotion) and finally cut to size.

At the outlet of the production apparatus 22, the packs of wet wipes are sent to a flow-pack packaging machine 24, which encloses the packs of wet wipes into respective wrappings of hermetically-sealed primary packaging. Figure 8 illustrates the exit area 36 through which the primary packages C exit the internal environment 20. A movable wall 92 can be provided, which closes the outlet opening in the event that there is no transit of finished products C. The positive pressure in the controlled environment 20 guarantees an air flow that leaves from the passage opening of the finished products C and prevents contaminated air entering from the outside. Once the products are sealed in the primary packaging, they are no longer susceptible to environmental contamination. Therefore, the sealed packages C can be packaged into packs or boxes (secondary packaging) outside the isolation structure 18.

The aqueous solution used for producing the wet wipes is prepared in the mixing area 38 located inside the isolation structure 18. The solid or liquid chemical compounds are mixed with purified and sanitized water coming from a special water purification and sanitizing plant. The opening of the primary packages of the chemical compounds used for producing lotion, the weighing and the addition of water to the chemical compounds are carried out in the internal environment 20 under microbiologically controlled conditions. In the small loading tanks 78, pure chemical compounds are premixed with purified water within the isolation structure 18. Purified water is used as a means of transport of the raw materials, as well as the basic ingredient of the solution. Suitable pumps with respective pipes transport the mixtures into the outer tanks 32. The outer tanks 32 are always closed and do not need to be opened for loading the compounds, and are also kept under positive pressure by being connected through air intakes 84 to the internal environment 20. In this way, there is no risk of contamination during the loading steps of the materials for preparing the lotion, during the subsequent mixing and storage steps of the finished lotions, and also during the periodic or occasional steps of cleaning and sanitizing the tanks and their pipes and related equipment, carried out with superheated water, steam or chemical sanitation solutions. In this way, it is not necessary to enclose the storage tank 32 in a microbiologically controlled area. This allows considerable volume reduction with controlled hygienic conditions. The manual weighing and loading operations of the base products for the lotions are carried out by operators within the controlled volume, without having to leave or go to other areas of the plant. The mixing containers 78 can even be washed after each batch of lotion.

Once the lotion preparation steps are completed in the outer tanks 32, the lotion is sent by means of pumps and pipes to the production line located in the internal environment 20, where it is sprayed in controlled quantities with flow meters and nozzles onto the sheets of substrates of the wipes under production. Outside the isolation structure 18, all the operations of controlling the finished packaged product (weighing of the full packs and external quality controls) and secondary packaging are performed, such as preparation of multiple packages, stacking into cardboard cases or boxes of various material, and finally possible palletization. Machines for these activities are located outside the isolation structure 18, in an environment that does not comply with the cosmetic GMP standards because they do not require specific measures to minimize the risk of microbiological contamination. Operators working in the area outside the isolation structure 18 can also perform the unpacking operations of the raw materials, as described above, and usually do not have to enter the isolation structure 18. This avoids indirect contamination due to the transit of people for operational or process reasons, and eliminates the operational costs and time for preparation at the entrance and exit of the isolation structure 18.

Of course, without prejudice to the principle of the invention, the details of construction and the embodiments can be widely varied with respect to those described and illustrated, without thereby departing from the scope of the invention as defined by the claims that follow.

Claims

1. A plant for producing cosmetic products, in particular for producing wet wipes, comprising:

- an isolation structure (18) installed inside a building (10) and having an internal environment (20) controlled in accordance with reference standards for producing cosmetic products,

- an air treatment assembly (38) for filtering and sanitizing a flow of air introduced into the isolation structure (18), configured to maintain a positive pressure difference between said internal environment

(20) and the external environment (12),

an apparatus for producing cosmetic products

(22) and a primary packaging apparatus of the cosmetic products (24) installed inside the isolation structure

(18), and

- a secondary packaging apparatus (26) installed outside the isolation structure (18) .

2. A plant according to claim 1, comprising a loading area (28) of raw materials for preparing solutions, mixtures or aqueous emulsions located within said isolation structure (18) comprising at least one pre-mixing tank (78) for loading and pre-mixing raw materials with purified water, wherein said at least one pre-mixing tank (78) is connected to at least one mixing and storage tank (32), located outside the isolation structure (18) and at least one delivery pipe (88) for feeding the aqueous mixture to said apparatus for producing cosmetic products (22) within said isolation structure (18) .

3. A plant according to claim 2, wherein said mixing and storage tank (32) includes an air intake

(84) connected to said internal environment (20) and which brings the air pressure in the mixing and storage tank (32) to the same value of the air pressure of the internal environment (20) .

4. A plant according to claim 1, wherein said isolation structure (18) comprises at least one entrance (34) for materials and/or personnel, comprising an intermediate chamber with double doors.

5. A plant according to claim 2, wherein said apparatus for producing cosmetics products (22) comprises a formation line of wipes imbued with aqueous solution.

6. A plant according to claim 1, wherein said primary packaging apparatus comprises a flow-pack packaging machine configured to form sealed packages of said cosmetic products.