GB2566552A

GB2566552A - Flexible enclosure

Info

Publication number: GB2566552A
Application number: GB1715097.0A
Authority: GB
Inventors: Ryder Martyn; Cocker Neil
Original assignee: Solo Containment Ltd
Current assignee: Solo Containment Ltd
Priority date: 2017-09-19
Filing date: 2017-09-19
Publication date: 2019-03-20
Anticipated expiration: 2037-09-19
Also published as: GB2566552B; GB201715097D0

Abstract

A flexible enclosure adapted to form a controlled environment having a flexible body 1 and an inlet filter 3 and outlet filter 2. The enclosure may be in the form of a cube or cuboid into which air may be passed through filter 3 at a high rate to provide a unidirectional airflow and a positive pressure. The body 1 may be supported in a frame 6. The enclosure is transportable and disposable with the integral filters and may be erected and assembled for use in a convenient manner without specialist tools or training.

Description

SYSTEM CONDENSED FOR SHIPPING

FLEXIBLE ENCLOSURE

This invention relates to an apparatus and methods for use in handling materials in a controlled environment enclosure, in particular apparatus and methods for aseptically preparing and filling pharmaceutical containers for example vials, under positive pressure. The invention particularly relates to a collapsible enclosure adapted for use in a uni-directional air flow system in a controlled environment.

Controlled environment enclosures are known and used for a wide range of applications to protect an operator and the environment against the contents of the controlled enclosure and to ensure the enclosure provides a suitable environment for processing or manipulation of equipment or materials within the enclosure.

Controlled environment enclosures are typically equipped with inlet and outlet air filters and may be equipped with transfer and arm access ports or access sleeves for transfer of equipment, materials and the like into and out of the enclosure. These ports/sleeves are adapted so as to enable external manipulation of equipment, parts or materials inside the enclosure. The ports/sleeves may typically comprise gloves or glove sleeves for manual manipulation of equipment or materials within the enclosure. External equipment for example automated equipment may be employed to enable manipulation of equipment or materials within the enclosure. The enclosure typically also an access and an exit port by which the equipment, parts or materials may be moved into and out of the enclosure.

Rigid isolator type clean area enclosures are known for providing a controlled environment in which the level of particulates does not exceed a pre-determined level according to the desired grade of environment required for the particular use. In fixed systems, high efficiency particulate air (HEPA) filters are typically employed to provide a positive pressure, uni-directional air flow system to remove air-borne particles to a requisite degree. By contrast, in flexible enclosures, negative air pressure systems are known which employ small breather-type or small flow capacity HEPA filters.

Such controlled environment enclosures may be used for a range of applications including hazardous compound or agent containment and aseptic processing of biological materials, for example, cell cultures and for the manufacture of biopharmaceutical products, medical devices, and the like. Such enclosures may also be used in the production or assembly of equipment or components which require a sterile environment such as medical products and equipment for example prefilled syringes and the like and products in other fields of use, for example in electronics.

Conventionally, controlled environment chambers are typically fabricated from stainless steel and include HEPA filters which are fixed in a pre-determined location. A typical large-scale vial filling system may involve multiple steps and apparatus or zones including a vial washer, a depyrogenation station, filler infeed to a controlled environment, a filling operation and a closure operation. Conventionally, air is passed though the controlled environment enclosure through HEPA filters to reduce the level of particulates to a suitably low level. Between batches, the enclosure is typically subjected to a cleaning or decontamination technique such as vaporised hydrogen peroxide (VHP) gassing to destroy microorganisms between batches or different procedures. Such cleaning or decommissioning and recommissioning processes may take a number of days to complete, leading to significant down-time.

The significant capital expenditure for such fixed isolation systems or enclosures and the significant down-time between batches may render smaller volume or value batches or runs economically unviable and utilisation of fixed controlled environment enclosures for low volumes or value of products is not feasible.

Flexible controlled environment enclosures are also known and enable a single use of the contaminated enclosure. Such systems typically have low air-flow ratings and provide, at best turbulent air flow. Flexible enclosures are convenient and may be quickly assembled and ameliorate some disadvantages of fixed enclosures. Conventionally, air filtration is provided by a filter for example a breather-type filter or by a small flow capacity HEPA filter, for example a cylinder filter, well known in the field, so as to create a negative air pressure within the enclosure. Typically, such arrangements enable airborne particle levels to be reduced to the desired level within a period of several hours. However, negative air pressure systems typically are not able to reach as low a level of particulates as air-flow systems.

In order to satisfy FDA and other global regulatory authorities it is a requirement to operate controlled environment chambers for aseptic filling at positive pressure and within a strictly controlled particle count limit. However, achieving a low particle count in a positive pressure environment in a reasonable timeframe is problematic, even when employing ultra low clean airflow devices.

We have now developed a flexible controlled environment enclosure having a positive pressure air-flow system including high flow-rate filters which is compact, transportable and disposable.

In a first aspect, the invention provides a flexible enclosure adapted to form a controlled environment, comprising a flexible body adapted to be configured into a threedimensional volume, a gas inlet filter adapted to transmit gas flow into the body and a gas exhaust filter for transmission of gas from within the body to externally of the body, the enclosure being configured so as to provide a pressure within the body greater than the external ambient pressure, that is a positive gas pressure within the enclosure.

The controlled environment is suitably defined by the body forming a volumetric space.

In a second aspect, the invention provides a method of providing an environment in which to carry out a process comprising:

i) providing a flexible enclosure adapted to form a controlled environment comprising a flexible body adapted to be configured into a three-dimensional volume, a gas inlet filter adapted to transmit gas flow into the body and a gas exhaust filter for transmission of gas from within the body to externally of the body;

ii) erecting the body so as to form a three-dimensional volume;

iii) connecting the gas inlet filter to an external air supply;

iv) feeding gas into the volume via the inlet filter so as to provide a pressure within the body greater than the external ambient pressure, that is a positive gas pressure within the enclosure; and

v) monitoring the level of particulate material within the volume so as to determine when the volume provides an aseptic environment.

The enclosure and method according to the invention may be employed in a wide range of fields including bio pharma, environments in which a “clean” environment is required, for example in assembling electronic equipment or components. The invention is especially suitable for providing an aseptic environment and for use in bio pharma or medical applications.

In a third aspect, the invention provides a method of carrying out a process in an aseptic environment which comprises providing a flexible controlled environment enclosure according to the first aspect of the invention, erecting the enclosure and providing an aseptic environment according to the second aspect of the invention, carrying out the process in the aseptic environment and disconnecting the inlet filter from the air supply, disconnecting the body from the support structure and disposing of the enclosure comprising the inlet and outlet filter.

The gas employed may be air, nitrogen or any other type of gas suitable for the intended use, preferably air. Preferably, the enclosure is configured to provide a uni-directional gas flow.

Advantageously, the enclosure of the invention is easily transportable, may be irradiated readily to sterilise the enclosure and is collapsible whilst providing a uni-directional airflow in a positive pressure environment. The present invention combines the high quality performance capabilities of costly and inflexible fixed enclosures through providing a positive pressure uni-directional air-flow through the enclosure with ease of use, lower cost and speed of changeover from operation to operation. This enables short term use, and safe disposability, free from contamination of the user or the environment in which the enclosure is used.

The enclosure of the invention is disposable and enables an operation, for example a batch processing operation, to be carried out and the enclosure to be readily replaced for the next operation. The enclosure of the invention advantageously does not require cleaning or decommissioning and recommissioning as with fixed controlled environment enclosures thereby avoiding significant downtime as well as the cost of capital investment. The present invention accordingly allows smaller runs or operations or lower value operations to be carried out that otherwise may not have been economically viable with fixed enclosures. This enhanced flexibility and economically viable field of use is also particularly advantageous for smaller laboratories or operations due to the lower economic demands than fixed controlled environment enclosures.

Suitably, the flexible body and the filters, for example HEPA filters, are permanently bonded into a single entity which is readily transportable. The collapsed enclosure and filters may be readily deployed, suitably manually without tools or engineering know-how and be ready for use in relatively short time.

The inlet filter may comprise an air distribution screen, a large HEPA filter or other similar device that enables passage of air whilst removing particulate materials of a specified size to a desired level. Suitably, the inlet and outlet filter has a surface area of at least 90000 mm², preferably at least 250,000mm², more preferably at least 350000 mm² especially at least 600,000mm², yet more preferably at least 750,000mm² and desirably at least 1,500,000mm². The filter assembly may be of any shape but preferably presents a square or rectangular filter area. In one embodiment, the filter is suitably 300mm x 300mm and especially 500mm x 500mm. Multiple filters may be grouped together to form a large arrangement whilst still being in the form of a non-rigid collapsible enclosure, suitably up to approximately 3000mm x 3000mm and preferably not more than 2000mm x 2000mm where required..

Suitably the inlet filter and outlet filter has an air flow capacity of at least 200m³/hr, preferably at least 300m³/hr, desirably at least 500m³/hr and particularly 1,000m³/hr in order to provide a positive air pressure in the body. The material employed in the filters and the area of the filter determines the rate of air flow in to the body of the enclosure. The material is selected to ensure that particulate material may be filtered out of the airflow to a desired specification. The maximum number of particles in a cubic metre to provide an aseptic environment for small-scale vial filling specification is as set out in Table 1 below:

Table 1

Gmdo	AS p®
65 pm	S.S pm	65 pm	§.0 pm
\| A	3526	20	3526	20
I ^&	3..S2O
I ^c:	'332.606	2.006	3526,606	20,060
I D	35W00	30.01X2	Not dofimto	Not d«<6ned

We have now found that by employing filters of larger size than previously considered feasible with a flexible enclosure, a positive air pressure system with a uni-directional airflow may now be employed within a flexible enclosure.

The filter is suitably housed in a filter assembly and suitably comprises a filter material able to remove particles of 5 microns and 0.5 microns to as to achieve the specifications set out in Table 1 as may apply for the intended use of the enclosure. Preferably, the filter comprises a 0.5 micron, preferably a 0.3 micron and more preferably a 0.2 micron air filter. Suitably the filter has a filter area of such a size as to enable an air flow rate of at least 10m³/hr, preferably at least 50m³/hr and desirably of at least 200m³/hr. In other embodiments, the air flow rate is at least 300 m³/hr for example 1,000m³/hr, enabling removal of particles to the desired specification.

Airflow distribution screens, HEPA filters and similar devices are known to be prone to accidental damage during handling. By mounting the filter in a housing, the filter is protected and the risk of accidental damage is correspondingly reduced.

In a preferred embodiment, the filter comprises a large panel HEPA filter permanently bonded to the flexible body of the enclosure. Suitably, the filter housing is releasably securable to apparatus external of the body, for example a fan housing to provide a source of air or an exhaust manifold, without the requirement for tools or specialist training. Preferably, the filter housing and the external apparatus are equipped with complementary inter-engagement means to enable rapid and simple connection and release, for example using a snap-fit or one-click fitting.

In a further aspect, the invention provides for the use of a filter assembly comprising a housing and a filter in a flexible controlled environment enclosure which comprises a flexible body adapted to define a three-dimensional volume adapted to receive gas via the filter assembly and a gas exhaust for transmission of gas from within the body to externally of the body so as to provide a uni-directional gas-flow, wherein the filter enables an air flow rate of at least 10m³/hr, preferably at least 50m³/hr and desirably of at least 200m³/hr.

The filter assembly is suitably adapted for sealed mounting in the body of the enclosure or in fluid communication with an aperture in the body of the enclosure. The filter assembly is in fluid communication with an external air supply, preferably a fan for example a high flow fan. The filter assembly preferably comprises mating parts adapted to engage with the air supply apparatus to allow quick and convenient connection of the enclosure to the air supply. Preferably the mating parts and the air-flow apparatus may be connected manually.

Advantageously, the filter and its housing are integral with the body of the enclosure such that the enclosure including the filter is disposable at the end of a run or batch operation. This configuration allows a rapid replacement of the flexible enclosure with integral filter whilst ensuring the contents of the enclosure remain within the enclosure thereby enabling safe handling disposal without contamination of the environment or operative.

Suitably, the enclosure including its filter assembly is sufficiently robust to be subjected to a sterilisation process prior to use. Preferably, the enclosure is subject to gamma radiation treatment. Conventionally, gamma irradiation is carried out by passing the apparatus to be irradiated through a tunnel. Desirably, the enclosure and its filter assembly is of such a size and configuration to be readily able to pass through a conventional gamma irradiation tunnel. Suitably, the filter assembly is shaped so as to be stackable with other filter assemblies. In a preferred embodiment, the enclosure comprises multiple filter assemblies, for example 4, and the multiple filter assemblies together with the flexible enclosure are stackable and of such size and configuration as to be able to pass through a conventional gamma irradiation tunnel.

Advantageously, by providing the filter assembly as an integral part of the enclosure, the enclosure may be tested at the manufacturing suite to enable appropriate quality control, collapsed into a transportable configuration thereby enabling efficient transportation. The enclosure may then be rapidly assembled at the point of use, preferably without a requirement for tools or specialist training, and be ready for use.

The body of the enclosure is preferably at least in part, and desirably wholly transparent to facilitate ease of use. The body is suitably configured that in use it forms a generally cube or cuboidal shaped body. Preferably, the gas inlet and inlet filter will be located on the top surface and the exhaust filter at the bottom surface. Suitably, the user will gain access to the enclosure using gloves or other means formed in the side panels. Preferably the body is constructed of flexible film material, for example transparent plastics material and is able to withstand a pressure of at least 50 Pa, preferably at least 100 Pa, more preferably at least 200 Pa for example at least 300 Pa. The filters are suitably mounted in the body and any seals between the body and filters or other components that are mounted in or in communication with apertures in the body are sufficiently robust to maintain a seal under the intended operating pressure.

The body is suitably manufactured from a roll of plastics film, preferably transparent and meeting regulatory compliance for contact with bio pharma products, for example sterile vials. The roll of film suitably provides flat panels of film which may be formed into a box shape and apertures formed at pre-determined locations as required and a filter assembly mounted and fixed in place with a gas tight seal. The body may define one chamber or volume or may define multiple chambers or volumes and the body may then be constructed accordingly. Where multiple chambers are formed, the dividing wall between the chambers may comprise openable and closable means, for example a zip of suitable construction and grade for use in an aseptic environment. Construction of the body of the enclosure advantageously may employ well-known techniques for forming plastics structures and utilise readily available materials, thereby providing benefits as regards the cost of production.

Preferably, the body is transparent.

Suitably, the body is made of FDA compliant polyurethane and contains bonded H14 HEPA systems.

The body suitably comprises gloves, preferably one or more pairs of gloves to allow manual manipulation of the contents of the body by an operator and/or may be adapted to allow externally located equipment to be employed in manipulating the contents of the enclosure.

The body is suitably supportable by fixing to a support structure which may be fixed to a solid surface for example a wall, floor or table, but is preferably a frame, for example a free-standing frame.

In a further embodiment, the invention provides a flexible controlled environment enclosure comprising a flexible body having a wall defining a hollow three-dimensional volume supported by a fixed structure, a gas inlet filter integral with the wall of the body for transmission of a gas flow into the volume and a gas exhaust filter integral with the wall for transmission of gas from within the body to externally of the body, the gas inlet filter being adapted for fluid communication with an air supply, the arrangement being such as to enable a uni-directional air flow to pass through the volume from the inlet filter to the outlet filter and providing a volume capable of being pressurised relative to the external ambient pressure.

The enclosure is suitably configured to be mounted on a tray. The tray is preferably a moulded plastics tray and may comprise a monitor or particle detector. The enclosure may comprise a spill tray or the filter assembly may be shaped so as to provide a spill tray within the enclosure that is disposable with the enclosure and the filters.

The enclosure is suitably used with a detector, preferably to allow monitoring of the contents of the environment in the body of the enclosure. In one embodiment, a detector for detection of the level of particulates, for example a particle counter with an isokinetic probe is located in a tray upon which the enclosure is mounted so as to monitor the particle levels in the air passing through the exhaust filter.

The enclosure will suitably be equipped with means to support the detector and, as appropriate, an aperture to allow connection of the detector to external equipment or services

The enclosure may further comprise one or more outlet apertures into which contents of the enclosure, for example, vials filled with product, waste materials and other equipment, parts or materials within the enclosure which need to be removed from the enclosure prior to completion of the operation and dismantling and disposal of the enclosure.

In one embodiment, the enclosure may provide a store chamber comprising a waste sleeve in communication with the enclosure via an outlet aperture. A store chamber may further comprise a sterilisation aperture to allow inflow of a sterilising material, for example vaporised hydrogen peroxide (VHP).

In another embodiment, the enclosure may provide a “fill” chamber in which a product which is to be loaded into a container in an aseptic environment, for example a biological product, a pharmaceutical product, a food product and an electronic product and wherein the enclosure comprises a heat seal sleeve for receiving the containers filled with product. Suitably, the exhaust filter may be adapted so as to prevent egress of sterilising material as desired.

Two or more enclosures according to the invention may be employed together with an openable and sealable partition portion between the adjacent enclosures to allow transfer of equipment, parts or materials from one to the other. In one embodiment, the partition portion may be a dividing wall which forms a part of both the adjacent enclosures. The partition portion may be openable by any suitable means for example a zip, which is preferably gas-tight. The partition may be opened to allow purging of a chamber by passage of air or other purge gas from one enclosure to the other.

Suitably, the enclosure comprises one or more connector apertures which may be blanked-off with a removable closure and which are adapted to allow multiple enclosures to be linked together by fluid communication means linking the connector apertures in two or more enclosures. The enclosures are accordingly suitable for modular use by connecting together a desired number of separate enclosures.

The enclosure may further comprise an air-flow distribution plenum mounted within the body to define a separate zone within the body interposed between the inlet filter and the main body of the enclosure such that as air passes through the inlet filter, into the separate zone and from the separate zone, through the plenum into the main body of the enclosure. The plenum suitably comprises and array of apertures which may be located and configured so as to improve the uniformity of distribution or to direct air flow to desired parts of the main body as may be required. The plenum suitably is made of perforated plastics material, for example polyurethane. Preferably, the array of apertures comprises up to 15%, preferably up to 10% for example 5% of the total area of the plenum.

The controlled environment enclosure may be used as a zone in which to carry out a batch process or a continuous process. The invention is suitable for use in a wide range of fields including pharmaceuticals, biopharma and in a chemical laboratory and clean room environment such as a manufacturing operation or filling lines where contamination is to be avoided, for example in the electronics industry and in manufacture of composites especially for high-stress applications such as aviation and automobile, other sterile areas including medical operating theatres. The enclosure of the invention is especially suitable as an isolator. The enclosure may in use comprise equipment for example plates or containers or vials for pharmaceutical products.

In use, the controlled environment enclosure may contain equipment or automated equipment, for example automated equipment for filling vials.

The enclosure according to the invention may be prepared for use in one or more stages. In a further aspect the invention provides a method providing an aseptic environment in which to carry out a process for example an equipment loading or parts preparation process comprising providing a flexible enclosure according to the invention in which the inlet and outlet ports are temporarily sealed and which is configured in a threedimensional volume; sterilising the body, for example by connecting a gas sterilising gas supply for example VHP to a port in the body and supplying the gas to the body; connecting the inlet filter of the enclosure to an air inlet supply port and the outlet filter to an outlet or exhaust port, subjecting the inlet and outlet filters to a sterilising process for example using VHP, while the enclosure is temporarily sealed, connecting the air inlet to an air supply and purging the chamber defined by the body with air, optionally opening a partition wall between adjacent chambers in the body if present and subsequently filling vials in the chamber in the presence of airflow.

The invention is now illustrated by the accompanying, non-limiting figures in which:

Figure 1 shows a perspective view of an enclosure according to the invention;

Figure 2 shows a perspective view of two adjacent enclosures according to the invention; Figure 3 shows a perspective view of an enclosure according to the invention with the flexible body omitted for clarity;

Figure 4 shows a side elevation drawing of an enclosure according to the invention;

Figure 5 shows a collapsed body with integral filters according to the invention.

Figure 1 shows a flexible body (1) configured to form a volumetric space and which is under positive pressure having received air from gas inlet filter assembly (2) which is square and adapted to fit into fan housing (3). The gas inlet filter assembly (2) is adapted to be connected to a gas supply for example a venturi fan. Gas outlet assembly (4) is located under spill tray (5) which provides a means of retaining spillage during use. The outlet filter assemblies (2, 4) enable adequate air flow to provide a positive pressure into body (1).

The body (1) is supported by external frame (6) and is equipped with glove sleeves (7). The body (1) defines a chamber which is separated from adjacent body (8) by an openable internal wall (9). The internal wall (9) may be openable by means of a zip or other airtight closure means. The chamber defined by body (1) may be a product handling chamber and the chamber defined by body (8) may provide an airlock from any further chambers or connected volumes (not shown).

The body (1) further has an outlet port (10).

Figure 2 shows an enclosure according to the invention as shown in Figure 1 when deployed for use comprising two bodies (1, 8) with a common dividing wall (9) having an openable zip (11). The bodies are suitably made of FDA compliant polyurethane and contain a bonded H14 HEPA system. The body (8) further comprises an inlet port (12). The enclosure comprises two inlet filters (2, 2a) and two outlet filters (4, 4a).

The filters (2, 4) may be readily deployed by connection to the fan housing (3) and the base plenum (13), for example a moulded tray, for example with a clip-fitting, not requiring any tools or specialist training. The moulded tray may contain detection or monitoring apparatus for example a particle count measuring probe.

The four filters and the bodies (1, 8) may form a self-contained single unit to allow for ready packing by stacking the four filters for transport, easy unpacking and deployment into the configuration shown in Figure 2 and disposal after use as a self-contained and sealed unit to avoid contamination.

Figure 3 shows the inlet and outlet filter assemblies (2, 4), for example a large panel HEPA filter, which are suitably bonded into the body (1) (not shown) to provide a selfcontained unit.

Figure 4 shows a side view of an enclosure according to the invention having a body (1) with an airflow distribution plenum (14). The plenum (14) may be made of FDA approved polyurethane sheet and suitably has an array of apertures to allow air through into the remainder of the chamber and for it to be directed across the chamber to provide improved uni-directional airflow. The HEPA outlet filter (4) in this embodiment is located in the end wall.

Figure 5 shows a folded body (1) with glove sleeves (7) mounted on a tray containing an exhaust port (not shown) where the enclosure is ready for deployment by attaching the body (1) to frame (6) and the inlet air filter (2) may be clipped into the fan housing (3) to provide a deployed enclosure as shown in Figure 1.

Claims

1. A flexible enclosure adapted to form a controlled environment, comprising a flexible body adapted to be configured into a three-dimensional volume, a gas inlet filter adapted to transmit gas flow into the body and a gas exhaust filter for transmission of gas from within the body to externally of the body, the enclosure being configured so as to provide a pressure within the body greater than the external ambient pressure.

2. A flexible enclosure according to claim 1 in which the inlet filter and outlet filter are adapted for use with air.

3. A flexible enclosure according to claim 1 or claim 2 in which one or more of the inlet filter and the outlet filter comprise a HEPA filter capable of removing particulate material of 0.3 micron or greater.

4. A flexible enclosure according to claim 3 wherein the filter is capable of removing particulate material of 0.2 micron or greater.

5. A flexible enclosure according to any preceding claim configured such that air flow from the inlet to the outlet filter is uni-directional.

6. A flexible enclosure according to any preceding claim wherein the inlet filter is dimensioned so as to enable an air flow rate of at least 10m3/hr.

7. A flexible enclosure according to claim 6 wherein the filter is dimensioned to have a flow rate of at least 100m3/hr.

8. A flexible enclosure according to any preceding claim wherein inlet filter comprises a large panel HEPA permanently bonded to the flexible body of the enclosure.

9. A flexible enclosure according to any preceding claim comprising a dividing partition whereby the body defines two chambers and wherein each chamber comprises an inlet filter and an outlet filter and the body is adapted to allow the chambers to be separate from or in fluid communication with each other.

10. A flexible controlled environment enclosure comprising a flexible body having a wall defining a hollow three-dimensional volume supported by a fixed structure, a gas inlet filter integral with the wall of the body for transmission of a gas flow into the volume and a gas exhaust filter integral with the wall for transmission of gas from within the body to externally of the body, the gas inlet filter being adapted for fluid communication with an air supply, the arrangement being such as to enable a uni-directional air flow to pass through the volume from the inlet filter to the outlet filter and providing a volume capable of being pressurised relative to the external ambient pressure.

11. A flexible controlled environment enclosure according to any one of the preceding claims which provides an aseptic environment within the three-dimensional volume.

12. A method of providing an environment in which to carry out a process comprising:

ii) erecting the body so as to form a three-dimensional volume;

iii) connecting the gas inlet filter to an external air supply;

13. A method according to claim 12 wherein the environment is aseptic comprising subjecting the flexible enclosure to a sterilisation process prior to and/or after erecting the body to provide a three-dimensional volume.

14. A method of carrying out a process in an aseptic environment which comprises providing a flexible controlled environment enclosure according to any one of claims 1 to 11, erecting the enclosure and providing an aseptic environment according to claim 12, carrying out the process in the aseptic environment and disconnecting the inlet filter from the air supply, disconnecting the body from the support structure and disposing of the enclosure comprising the inlet and outlet filter.

15. Use of a filter assembly comprising a housing and a filter in a flexible controlled environment enclosure to provide an air flow through the enclosure of at least at least 10m3/hr wherein the enclosure comprises a flexible body adapted to define a three dimensional volume adapted to receive gas via the filter assembly and a gas exhaust for transmission of gas from within the body to externally of the body so as to provide a unidirectional gas-flow, wherein the filter has a filter area of such a size as to enable an air flow rate of at least 10m3/hr.

16. Use of a filter according to claim 15 wherein the filter area is of such a size as to enable an air flow rate of at least 200m3/hr.

17. Use of a filter according to claim 15 or claim 16 wherein the filter comprises a 0.5 micron air filter.

18. A method of providing an aseptic environment in which to carry out a process comprising providing a flexible enclosure according to any one of claims 1 to 11 in which the inlet and outlet ports are temporarily sealed and which is configured in a threedimensional volume, sterilising the body, connecting the inlet filter of the enclosure to an air inlet supply port and the outlet filter to an outlet or exhaust port, subjecting the inlet and outlet filters to a sterilising process while the enclosure is temporarily sealed, connecting the air inlet to an air supply and purging the chamber defined by the body with air, where the body comprises multiple chambers, optionally opening a partition wall between adjacent chambers in the body thereby to purge a second or further chamber and subsequently filling vials in the chamber in the presence of airflow.