Aseptic containment chamber provided with lighting system and relative method of adjusting the light inside the aseptic containment chamber

Abstract

An aseptic containment chamber defines a containment volume for the handling and / or processing of chemical-pharmaceutical-biological substances and comprises a lighting system with adjustable colour temperature; the lighting system comprises a lighting body having at least one LED source configured to emit at least one beam of warm light and / or a beam of cool light of adjustable intensity and directed towards the inside of the containment volume and at least one unit for the adjustment and / or partialisation of the current in relation to the voltage and / or intensity for adjusting the emission of the beam of warm and / or cool light from the LED source.

Description

[0001] ASEPTIC CONTAINMENT CHAMBER PROVIDED WITH LIGHTING SYSTEM AND RELATIVE METHOD OF ADJUSTING THE LIGHT INSIDE THE ASEPTIC CONTAINMENT CHAMBER

[0002] DESCRIPTION

[0003] The present invention relates to an aseptic containment chamber for the handling and processing of chemical-pharmaceutical-biological substances, provided with a lighting system, and finds application in the pharmaceutical, hospital, research, advanced gene therapies, biotechnologies (and the like), for handling and processing chemicalpharmaceutical substances.

[0004] A method for adjusting the light inside the aseptic containment chamber is also an object of the present invention.

[0005] Therefore, the present invention finds application in the sectors where it is essential to maintain a sterile environment in which it is common to resort to barrier systems generically referred to as “aseptic containment chambers”.

[0006] According to the state of the art, the term “aseptic containment chamber” means a boxed, closed or semi-closed environment, for example in the shape of a parallelepiped made of rigid material such as stainless steel, with at least one transparent front face portion and provided with access to perform a handling by an operator, for example a lower slot or gloved flanges into which the operator can insert his / her arms.

[0007] In each containment chamber there is at least one incoming filtered air flow so that the environment is suitable to allow the manual or semimanual handling or processing of pharmaceutical active ingredients and / or chemical compounds (or even, depending on the needs of the moment, of biological origin) by specialized personnel, by means of equipment such as peristaltic pumps, centrifuges, sealers and other assisted systems.

[0008] Generally speaking, the containment chambers are intended to separate the process from the operator and from the environment outside the aseptic containment chamber itself, in order to protect the handled product from contamination outside the aseptic containment chamber and / or protect the operators and the environment from pharmaceutical active ingredients and / or chemical compounds, also of biological origin, handled inside the aseptic containment chamber.

[0009] The aseptic containment chamber is configured as a real “system” when, for example in the “insulator machine” configuration, it is enslaved by a myriad of further systems such as, for example, a system for forced ventilation or a pass-box chamber side by side for the intermediation of other material and so on.

[0010] It is known that within these containment chambers sterility tests are performed to validate drug production batches, biological material is handled for the development of advanced cell-genic-tissue therapies for medical and research treatments and prostheses, surgical instruments and diagnostic devices are made, therefore, aseptic conditions are often required to ensure patient safety.

[0011] The production of drugs and products for topical, dermatological and ocular use also requires sterile environments to avoid microbiological contamination of the products.

[0012] In general, the aseptic containment chamber is fundamental in any context where microbiological or particulate contamination may compromise the safety, quality or integrity of the products or processes.

[0013] It is evident that an incorrect procedure or a potential contamination of the treated material can firstly cause a considerable economic damage to the production of the drugs, and secondly represent a potential risk, albeit very remote given the levels of control, for the end users of such drugs.

[0014] Such aseptic containment chambers can also be used to protect personnel and the external environment from contaminations, this is the case of all those contexts in which one works with hazardous materials, such as radioactive substances or toxic chemical agents or even with sensitive samples for which the occurrence of such contamination would invalidate the results of the tests carried out on said samples.

[0015] In general, such chambers are required where contamination may affect the operational performance or, in other words, where handling and production of objects within such chambers must take place in volumes free of contamination.

[0016] In general, the aseptic containment chamber is fundamental in any context where microbiological or particulate contamination may compromise the safety, quality or integrity of the products or processes.

[0017] The operational-postural-ergonomic working condition in which operators specialised in these processes work is certainly not ideal, for example due to the levels of protection that intervene in handling. Think of the glass that stands between the operator and the operating environment, the consequent posture that the same operators must take while keeping their arms tucked into the slot or gloved flanges, the same thick gloves that must be worn, but also the light conditions in which the workers operate and the reflections caused by the internal environment typically made of polished stainless steel panels.

[0018] With regard to light, there is actually a further factor that affects the wellbeing of the operator, and can certainly affect in the short and long term the outcome of his / her work and above all his / her health; this factor concerns the internal lighting of the rooms, of a known type and for standard use, which is made by means of LED-type sources characterized by a steady type white light colour temperature, typically higher than 5000K, that is, a light with a highly impacting blue light component, a light of often steady intensity measured at about 500 lux on the work surface and a colour rendering index (CRI) usually lower than 80 Ra.

[0019] This type of lighting, far from ideal, subjects operators to high stress, especially of a visual-ocular type but not only given the work circumstances indicated above and considering that the work cycles also last many hours during which the operator is forced to keep his / her gaze fixed inside the aseptic containment chamber, performing operations that are not simple and whose outcome as we have explained is relevant, both economically and also for any potential negative consequences that may fall on the processed substances.

[0020] Some studies have pointed out how cool white light, rich in blue spectrum, negatively affects retinal activation by altering circadian rhythms and metabolic balance.

[0021] The body self-adjusts the sleep-wake rhythm by means of a mechanism, discovered only a few years ago, which depends on the type of light spectrum that enters the eye and hits the retina by activating the photo pigment melanopsin, activator of the hormone melatonin, known for defining the body's sleep-wake rhythms.

[0022] This self-adjusting process is consequent and inherent in human evolution itself, which took place with its alternation between day and night. This daily variation corresponds to the variation in the so-called colour temperature of light, which varies as the sun rises above the horizon, and which therefore determines the synthesis of melatonin and consequently circadian cycles.

[0023] These cycles, as it was discovered, also through the activation of numerous other metabolic variables, determine the quality not only of sleep, but also of wakefulness, of the stress suffered by the body, of the levels of attention, and also of many physiological parameters that, unfortunately, if altered, compromise the health condition of people.

[0024] The type of process that the operator must carry out, whose vision must remain acute for the entire processing time, while maintaining a high level of vigilance and attention, is potentially compromised precisely by the certainly not ideal lighting conditions and which also determine the negative correlates exposed above.

[0025] Therefore, in addition to the potential damage of economic value resulting from any operations carried out in conditions of fatigue or inattention, for example the risk of nullifying a production batch for a sterility test conducted clumsily, it is wished to highlight that the level of general wellbeing and the state of health of the operators involved is also at stake.

[0026] The technical task of the present invention is therefore to make available an aseptic containment chamber and a method of adjusting the light inside the aseptic containment chamber that are able to overcome the drawbacks arising from the prior art.

[0027] The object of the present invention is therefore to make available an aseptic containment chamber and a method of adjusting the light inside the aseptic containment chamber that are able to generate a lighting condition that is ideally adjustable and pleasant for the specific operating conditions and for the physiology of the operator and can therefore produce countless benefits, first of all for the health of the operator, but also for the outcome of his / her work.

[0028] Further, the object of the present invention is therefore to make available an aseptic containment chamber and a method of adjusting the light inside the aseptic containment chamber in which the light is adjusted consistently with respect to the day-night cycles, in order to minimize the disturbance of the circadian rhythms of the operators and with the ultimate aim of keeping the operators in conditions of undisturbed vigilance and attention and with an improved health and metabolic balance situation, when compared to the usual lighting conditions provided for the aseptic containment chambers.

[0029] The technical task and the specified purposes are substantially achieved by an aseptic containment chamber and a method of adjusting the light inside the aseptic containment chamber provided with a lighting system, with adjustable colour temperature of white light, comprising the features set forth in one or more of the claims. The dependent claims correspond to possible embodiments of the invention.

[0030] In particular, the specified technical task and the specified purposes are substantially achieved by an aseptic containment chamber and a method of adjusting the light inside the aseptic containment chamber defining a containment volume, for the handling and / or processing of chemicalpharmaceutical substances, comprising a lighting system with adjustable colour temperature of white light comprising at least one lighting body, in turn comprising at least one LED source configured to emit at least one beam of warm light and / or a beam of cool light of adjustable intensity and directed towards the inside of the containment volume defined by the chamber itself.

[0031] For example, the lighting system with adjustable colour temperature of white light also comprises at least one unit for the adjustment and / or partialisation of the current in relation to the voltage and / or intensity for the LED source.

[0032] The present invention, therefore, overcomes the drawbacks of the known art by proposing an aseptic containment chamber and a method of adjusting the light inside the aseptic containment chamber with adjustment of white light dynamically, this adjustment being related to the specific needs of the operator and according to the processes carried out within it and / or the day-night cycles and / or according to the times, the season, the weather and the material to be processed.

[0033] The advantage of the present invention is therefore to positively affect the level of attention and psycho-physical well-being of the operators.

[0034] Further characteristics and advantages of the present invention will become clearer from the indicative, and therefore non-limiting, description of some preferred but not exclusive embodiments of an aseptic containment chamber comprising a lighting system with adjustable colour temperature of white light, illustrated in the attached drawings in which: figures 1 to 6A show a diagram of possible embodiments for an aseptic containment chamber and related lighting systems.

[0035] With reference to the attached figures, 1 denotes an aseptic containment chamber which, for simplicity of description, will be referred to below as chamber 1 .

[0036] The chamber 1 , which defines a containment volume 2 for the handling and / or processing of chemical-pharmaceutical substances, comprises a lighting system with adjustable colour temperature of white light.

[0037] The lighting system comprises at least one lighting body 3 comprising at least one LED source 3a configured to emit at least one beam of warm light, which for example can be white, and / or a beam of cool light (which in turn can always be white or in any case fall within the spectrum commonly associated with the definition of “white light”), of adjustable intensity and directed towards the inside of the containment volume 2 itself.

[0038] Furthermore, the lighting system comprises at least one unit for the adjustment and / or partialisation of the current in relation to the voltage and / or intensity for adjusting the emission of the beam of warm and / or cool light emitted by the LED source 3a.

[0039] The at least one lighting body 3 can be positioned inside or outside the containment volume 2, for example in a peripheral structure of the containment volume 2.

[0040] In other words, in an actual application shown in figure 2, the lighting body 3 is positioned outside the containment volume 2 at a transparent front face portion.

[0041] In addition, in an upper portion of the chamber 1 , there are a diffuser element 5 and a filtering element 6 placed above the diffuser element 5; therefore, according to an embodiment, the lighting body 3 is arranged between the diffuser element 5 and the filtering element 6.

[0042] To allow a greater diffusion of the light emitted in the containment volume 2, the configurations shown in figure 3-5 provide that these LED sources 3a are positioned above the diffuser element 5, made for example in the form of a gauze or panel, placed in the upper portion of the chamber 1 and typically present with the purpose of creating a constant and laminar air flow from top to bottom.

[0043] In other words, the LED sources 3a are placed between the diffuser element 5 and the filtering element 6 placed above the chamber, the latter configured to filter the air and delimit the upper portion of the aseptic chamber 1 .

[0044] For example, the at least one lighting body 3 is made by means of an aluminium guide. In addition, the LED source 3a, which comprises a power supply circuitry, is coated with a transparent sealing material, preferably a polymer, even more preferably a cast polymer (which for example can cover the LEDs 3a as visible in figure 1a, where a body 3d made of this material and arranged around the LEDs 3a itself is visible).

[0045] In other words, according to a further aspect since in the chamber 1 it is not possible to insert an LED source 3a with a circuitry and / or board and / or screens that constitute recesses and that can retain and release impurities, volatile elements and pollutants, the lighting body 3 is contained inside an aluminium guide and the LED source 3a and its circuitry are coated with a transparent cast polymer, for example of a silicone type, in order to confine the LED board part and the circuitry from the environment that must be kept aseptic.

[0046] According to a possible embodiment, the chamber 1 comprises a plurality of lighting bodies 3 distributed inside or outside the containment volume 2 and positioned in a peripheral structure of the containment volume 2.

[0047] Advantageously, the containment volume 2 is defined below by a work surface that can conveniently be made of brushed sheet metal; more generally, in order to reduce the eye fatigue of the operators, it is possible that the chamber 1 internally is totally or selectively made not of polished sheet metal but of brushed sheet metal, while maintaining the characteristics of surface finish and minimum roughness necessary for processing in the chemical and pharmaceutical fields, as well as remaining consistent with the standards necessary for its cleaning and disinfection and according to the guidelines of correct design and execution GMP (Good Manufacturing Practice).

[0048] In addition, at least one LED source 3a is of the high colour rendering index (CRI) type, in particular greater than 90 Ra, for example greater than 94 Ra. In particular, LEDs with particular colour rendering indices may be selected and used, for example in relation to R9 for red and / or R13 for flesh-pink colour, also depending on the purpose for which the chamber 1 will be defined and designed and therefore also based on the type of materials and chemical-pharmaceutical substances to be treated.

[0049] Advantageously, a high colour rendering index (CRI) allows a more faithful recognition of colours and consequently reduces the visual-eye fatigue of the operators.

[0050] According to different embodiments of the invention, one or more lighting bodies 3 may be present inside the chamber 1 , each of which is characterized by an LED source 3a comprising at least a first LED 3b for emitting cool light and / or at least a second LED 3c for emitting warm light. In accordance with an embodiment reported in figure 1A, the LED source 3a comprises the first LED 3b, for the emission of particularly cool light, for example, white light emitted at 6000 K, and the second LED 3c for the emission of particularly warm light, for example, white light emitted at 3000 K.

[0051] Therefore, the emission of a mediated spectrum conforming to the needs of the operator is obtained, for example, a white light spectrum with a colour temperature of 4500 K.

[0052] This mediated spectrum between the beam emitted by the first LED 3b and that emitted by the second LED 3c will result from a partial adjustment-partialisation of the current in relation to the voltage and / or intensity, thus adjusting at least a first cool LED 3b and a second warm LED 3c, acting indifferently in volt-amperes and / or in amplitude and / or frequency of the square wave PWM (Pulse Width Modulation) supplying the LEDs.

[0053] In fact, it is essential to define how different LEDs collaborate with each other to obtain a certain light with the desired colour temperature and intensity.

[0054] In other words, the chamber 1 comprises an adjustment unit 9 configured to adjust the beam of cool light and / or the beam of warm light by acting in volts / amperes and / or amplitude and / or frequency of the square wave supplying the LED source 3a.

[0055] This adjustment mode can then be carried out by dynamically adjusting the white, i.e. the intensity of one or both of the at least two types of warm and cool LEDs.

[0056] It will also be possible to adjust the lighting intensity, for example by varying from 200 lux to 800 lux overall detected on the lower surface of the chamber 1 , to increase or vice versa to decrease, setting a certain spectrum of the white, for example at 4800 K as a result of a certain intensity of both warm and cool LEDs.

[0057] For example, this adjustment in perceived lux may vary between 50 lux and 1000 lux, being able to vary progressively as desired between a warm white light, for example of 3000 K and a cool white light, for example at 6000 K.

[0058] For example, the adjustment unit 9 is configured to vary the intensity of the light by means of predetermined intensity adjustment steps, each step being associated with a temperature variable between cool white and warm white.

[0059] Advantageously, the present invention allows the temperature of the white light to be varied, from warm to cool, and / or from a minimum to a maximum intensity, in a gradual manner.

[0060] In a variant of use, it will be possible to vary the white temperature from warm to cool by means of predetermined adjustment steps, for example in five steps in which the first step corresponds to a white temperature equal to 3100 K, the second to 3800 K, the third to 4500 K, the fourth to 5200 K and the fifth to 5900 K.

[0061] In other words, according to the possible piloting embodiments, pairs of piloting currents are defined that supply the piloting driver of the LEDs 3b and 3c, therefore it is possible to vary the intensity and temperature of the light, preferably white, from 3100K to 5900K with positions from 1 to 5 and / or with positions from A to E. For a further exemplification of the present invention, reference may be made to the following table:

[0062] “temperature *K from min to max in 5 steps” =

[0063] In the example shown in the table reported above, the 1 -10 volt piloting driver has a minimum threshold for switching on at a minimum intensity of 4 volts; therefore, the intensity adjustment of the LEDs 3b and 3c will take place by varying the power supply from 4 to 10 volts (and more particularly, with reference to the table just reported, it can be seen that each of the two LEDs 3b and 3c has its own range of variation of the power supply voltage).

[0064] The values of the voltages indicated in the table reported above are only representative of an example of possible values assumed by this magnitude, according to the same embodiment the voltage is for example comprised between 0 V and 240 V or, according to the needs of the moment, can be comprised between 1 V and 24 V.

[0065] In addition, light intensity and temperature can obviously be modified starting from any pair of cells and moving cyclically in steps and then intermediating any possible piloting through the driver 1 .

[0066] In a different variant of use, it will be possible to vary the intensity of the light perceived in the chamber 1 , maintaining a certain set white temperature, for example 4500 K, by means of predetermined intensity adjustment steps, for example in five steps where the light detected on the lower surface of the chamber 1 corresponds for the first step to 200 lx, for the second to 400 lx, for the third to 600 lx, for the fourth to 800 lx and for the fifth to 1000 lx.

[0067] A further example of how it is possible to pilot “by discrete steps” both the intensity and the colour temperature of white light is provided by the following table which, unlike the previous one which is expressed in volts, is expressed below in percentage values (comprised between a minimum of 0% and a maximum of 100%) of the so-called “duty-cycle PWM”, i.e. the amplitude of the power supply wave from a minimum of 0 out of 100 to a maximum of 100 out of 100. “temperature *K from min to max in 5 steps” = with reference to the table presented above, it should be pointed out that the fact of expressing the values in percentage makes it evident that, given that the type of LED at a higher colour temperature typically emits more lumens than the LED at a lower temperature and given the need to vary the temperature of the light obtained from the emission mix of both sources while maintaining the intensity constant, a possible control strategy implementable by the present invention can conveniently be constituted by piloting both LED sources with a specifically studied and verified power supply, thus experimentally ascertaining the outcome with appropriate instruments (for example, a spectrum -radiometer).

[0068] It is specified that the intensity of the light detectable in lux (lx) on the work surface will obviously be due to the current adjustment of the LEDs 3b and 3c and how they consequently radiate in Lumens.

[0069] For example, the adjustment unit 9 is further configured to vary the light intensity according to a day-night light cycle.

[0070] In other words, to vary the temperature of the white light and / or the intensity of the light, it is possible to operate by means of “preset recipes” according to the day-night cycle, i.e. by reproducing a white light inside the machine whose temperature and / or intensity reproduce a brightness and a type of white light consistent with the time of day.

[0071] In particular, this “recipe” considers at the beginning of the day a warm white that gradually becomes cool at the end of the morning and after a few hours it returns again to a warmer white from the afternoon. For example, assuming the use of a room 1 from 8 a.m. to 6 p.m. on a typical working day in the summer, for example, a white colour temperature adjustment can be assumed, as the hours vary, as follows: 8 a.m. - 3800 K, 9 a.m. - 4000 K, 10 a.m. - 4400 K, 11 a.m. - 5000 K, 12 a.m. - 6000 K, 1 p.m. - 6000 K, 2 p.m. - 5800 K, 3 p.m. - 5500 K, 4 p.m. - 5000 K, 5 p.m. - 4400 K e 6 p.m. - 3800 K.

[0072] In addition, the recipe adjustments can take into account the seasonality of the days, or even the weather and external lighting conditions, in the real geographical environment, adjusting the variations with an appropriate frequency, for example also every minute.

[0073] In the same way, it will also be possible to vary the lux intensity regardless of the environment, obviously in a manner compatible and consistent with the operational and functional needs of the chamber 1 , i.e. the needs of the user who must operate with the chamber 1.

[0074] According to a further embodiment, the LED source 3c is a yellow or amber type source, in use configured to process photosensitive or blue light degradable materials.

[0075] In other words, a yellow or amber type of LED can be used, for example, if photosensitive or blue light degradable materials must be processed, while maintaining any white adjustment functions as indicated above.

[0076] Therefore, it is possible to operate in particularly warm light when treating photosensitive materials, while it is possible to use light adjustable towards cool light or exclusively cool light where the risk of degradation of the photosensitive material has ceased.

[0077] Furthermore, in accordance with an embodiment shown in figure 6, the chamber 1 is provided with a lower slot 7 through which the operator can handle objects inside the containment volume 2, this slot 7 replaces the gloved flanges 8 (or a similar access interface) in which traditionally the operator from the outside inserts his / her arms to work inside the containment volume 2 of the chamber 1 .

[0078] It is also an object of the present invention a method of adjusting the light inside the aseptic containment chamber that allows to vary the lighting inside the aseptic containment chamber 1 according to the lux detected on the work surface, to vary the lighting inside the aseptic containment chamber 1 according to the day-night cycle, to vary the lighting inside the aseptic containment chamber 1 consistently with the time of day and finally to vary the lighting inside the aseptic containment chamber 1 consistently with the process that occurs inside the aseptic containment chamber 1 itself. Advantageously, the chamber 1 is provided with a lighting system and a method of adjusting the white light dynamically; this dynamic white adjustment is related to and / or a function of the processes carried out within it and / or a function of the material to be processed.

[0079] In addition, this system adjusts the white light in a dynamic manner in line with the specific needs of the operators and the processes they must carry out, day-night cycles, according to the hours, seasons or weather, positively affecting the level of attention and well-being of the operators.

[0080] Advantageously, the present invention proposes a chamber 1 for the handling and processing of chemical-pharmaceutical-biological substances provided with a lighting system and a method of adjusting white light dynamically aimed at obtaining the maximum health of the operator (and also to maximize the outcome of his / her work).

[0081] Advantageously, the lighting system composed of one or more lighting bodies 3, each of which provided with one or more specific LEDs, warm or cool, emits a resulting spectrum that is due to a partial adjustment of the power supply current of the LEDs themselves; to obtain an optimal adjustment of the white light on the basis of the different needs that may occur inside the chamber 1 .

[0082] Advantageously, the method of adjusting white light dynamically allows to set the most varied “recipes” for dynamic lighting management, such as, for example, at least one “recipe” that provides for the dynamic variation of the resulting white light during the course of the day, thus determining a kind of “dynamic white” that follows and reproduces, simulating it with a predetermined degree of “proximity” or correspondence, the natural sunlight of that given day taking into account the calendar (and therefore taking into account the season and so on) or even a “recipe” in which the resulting lighting can change more or less suddenly and automatically (for example, in terms of intensity and / or colour of the light), to send signals perceptible to the operator such as for example a signal of attention, a warning signal of an excessive period of continuous work or anything else, always depending on specific needs.

Claims

CLAIMS1 . Aseptic containment chamber (1 ) for the handling and / or processing of chemical-pharmaceutical-biological substances, defining a containment volume (2) and comprising a lighting system with adjustable colour temperature,Characterised in that said lighting system comprises:- at least one lighting body (3) comprising at least one LED source (3a) configured to emit at least one beam of warm light, preferably white light, and / or one beam of cool light, preferably white light, of adjustable intensity and directed towards the inside of said containment volume (2); and- at least one unit (9) for the adjustment and / or partial isation of the current in relation to the voltage and / or intensity for adjusting the emission of said beam of warm and / or cool light of said LED source (3a).

2. Aseptic containment chamber (1 ) according to claim 1 , wherein at least one lighting body (3) may be positioned inside said containment volume (2) or outside said containment volume (2) in a peripheral structure of said containment volume (2).

3. Aseptic containment chamber (1 ) according to claim 1 or 2, comprising a plurality of lighting bodies (3) distributed inside or outside said containment volume (2).

4. Aseptic containment chamber (1 ) according to one or more of the preceding claims, wherein said LED source (3a) comprises at least a first LED (3b) for emitting cool white light, preferably greater than 5000K, even more preferably greater than 5500K and / or at least a second LED (3c) for emitting warm white light, preferably lower than 3500K, even more preferably lower than 3000K.

5. Aseptic containment chamber (1) according to any one of the preceding claims, wherein the lighting body (3) is made by means of an aluminium guide.

6. Aseptic containment chamber (1 ) according to claim 1 , wherein the LED source (3a) comprises a power supply circuitry, said LED source (3a) being coated with transparent sealing material, preferably a polymer, even more preferably a body (3d) made of said polymer.

7. Aseptic containment chamber (1) according to any one of the preceding claims, wherein at least one LED source (3a) is of the high colour rendering index type preferably with a CRI higher than 90, even more preferably higher than 95.

8. Aseptic containment chamber (1) according to any one of the preceding claims, wherein said containment volume (2) is at least partially defined by at least one work surface, said at least one work surface being preferably a lower work surface made of brushed metal sheet, the inner walls of said containment volume (2) being even more preferably made entirely or selectively of brushed metal sheet.

9. Aseptic containment chamber (1) according to any one of the preceding claims, comprising in an upper portion of said aseptic containment chamber (1 ), a diffuser element (5) and a filtering element (6) placed above said diffuser element (5), at least one lighting body (3) being arranged between said diffuser element (5) and said filtering element (6).

10. Aseptic containment chamber (1 ) according to any one of the preceding claims, wherein said adjustment unit (9) is configured to adjust said beam of warm light, preferably white, and / or said beam of cool light, preferably white, by acting in volts / amperes and / or amplitude and / orfrequency of a square wave supplying the LED source (3a).

11. Aseptic containment chamber (1 ) according to any one of the preceding claims, wherein said adjustment unit (9) is configured to vary the light intensity by means of predetermined intensity adjustment steps, each step being associated with a temperature variable between cool white and warm white.

12. Aseptic containment chamber (1 ) according to any one of the preceding claims, wherein said control unit (9) is configured to vary the light intensity according to a day-night light cycle.

13. Aseptic containment chamber (1 ) according to any one of the preceding claims, wherein the LED source (3c) is a yellow or amber type source, configured in use to process photosensitive or blue light degradable materials.

14. Method of adjusting the light inside the aseptic containment chamber (1 ) according to any one of the preceding claims, comprising the steps of:- varying the lighting inside the aseptic containment chamber (1) according to the lux measured on the work surface; and / or- varying the lighting inside the aseptic containment chamber (1) according to the day-night cycle; and / or- varying the lighting inside the aseptic containment chamber (1) according to the time of day; and / or- varying the lighting within the aseptic containment chamber (1) in line with the process occurring within the aseptic containment chamber (1 ) itself.

15. Method of adjusting the light inside the aseptic containmentchamber (1 ) according to any one of the preceding claims, comprising the steps of:- defining the current pairs supplying the piloting driver;- exceeding the threshold for switching on the driver; and - dynamically varying the light intensity and white temperature by selecting the appropriate intensity-temperature pairs.

16. Method of adjusting the light inside the aseptic containment chamber (1 ) according to any one of the preceding claims, comprising the steps of: selecting a dynamic lighting management “recipe”; and / or determining a “dynamic white” that follows and reproduces natural sunlight on a predetermined day taking into account a calendar; and / or selecting a “recipe” wherein a resulting lighting can change more or less abruptly and automatically to send perceptible signals to an operator, said perceptible signals being preferably alarm or confirmation signals of an operation having taken place.

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