DE102014013299A1 - Method for creating a local protection zone in exterior cleaning machines in connection with isolators for the aseptic production of medicaments - Google Patents

Abstract

The invention is characterized in that 1. an angeordete after an insulator cleaning machine (see drawing, area 1) is equipped with a supply air system, 2. the supply air is injected into an inlet region of the cleaning machine, which on the one hand to the outlet of the insulator (see Drawing, area 2) and on the other hand to the washing area of the cleaning machine (see drawing, area 5) has openings for the transport of sealed containers with product, 3. the supplied by the aforementioned air supply system area of the cleaning machine (see drawing, area 1) with excess air is operated, so that from the aforementioned adjacent areas no air flows into the area supplied by the Zuluftsystem area of the cleaning machine.

Description

State of the art

In the aseptic production of drugs, the isolator technology is increasingly being used. This represents the state of the art, especially in the case of toxic products.

The insulators for the continuous production of pharmaceuticals have openings at the inlets and outlets, so-called mouse holes.

The mouse holes at the outputs of the plants are often operated under reduced pressure in order to separate a safe separation of the production area for the sterile processes from the surrounding clean room.

In particular, in the production of toxic sterile medicines, an exterior cleaning machine for cleaning the sealed containers is positioned at the exit of the insulator. This exterior cleaning machine is connected directly to the insulator. This is necessary because the products potentially contaminated with toxic substances may not be discharged from the isolator untreated for reasons of personal safety and contamination of other products. The resulting in the washing area of the outdoor cleaning machine moisture due to cleaning with water is sucked through usually by separate exhaust air systems. Thus, this area is operated in negative pressure relative to the surrounding clean room.

According to the European regulations, isolators for the production of sterile drugs may be placed in cleanrooms of the so-called class "D" [1].

Internationally, depending on country-specific regulatory requirements, there is a tendency or immediate requirement to install isolators for the manufacture of sterile pharmaceuticals in accordance with the US "US Safe and Drug Administration" in clean rooms that conform to ISO Class 8 [2 ]. This requirement can be compared with the clean room class "C" from European standardization [1].

To help with the installation of the insulators (see drawing, area 3 ) for the manufacture of sterile drugs in class "D" cleanrooms, also to meet the requirements of authorities requiring their installation in class "C" rooms [2], the inputs and outputs of the systems are protected by local protection zones with respect to the clean room environment, the requirements of the class "C" are met. These local protection zones can be realized by so-called laminar flow units, which are installed above the inputs and outputs.

When positioning the aforementioned laminar flow units above the exit of the exterior cleaning machine, there is the problem that within the exterior cleaning machine system-related significant water attack exists, so that the conditions of cleanliness class "C" can not be met there. An alternative is to add a separate insulator module between the output of the insulator and the external cleaning machine, which fulfills the function of the local protection zone with the properties of the cleanroom class "C". However, this solution is unfavorable because this module incurs significant additional investment and operation costs. The space requirement is also a hindrance.

Description of the invention

The present invention relates to a method according to which the local protection zone with the properties of the clean room class "C" by a in the inlet region (see drawing, area 1 ) the exterior cleaning machine integrated ventilation module is created.

The external cleaning machines for cleaning the potentially toxic contaminated containers are protected at least in the area in which toxic containers are transported to the environment as well as the insulators themselves. Thus, while maintaining personal protection without an additional insulator module within these systems with very little effort an air-technical area is established, which represents a room with the properties required by [2] and thus fulfills these requirements even if the system itself is in a class "D" cleanroom.

This module (see drawing, area 1 ) is supplied with air, which was passed as the last filter stage via a HEPA filter of at least class H13.

The amount of air is chosen so large that both the negative pressure in the mouse hole (see drawing, area 2 ) as well as operated in the vacuum washing, drying and discharge area of the exterior cleaning machine (see drawing, areas 5 . 6 . 7 ) are supplied with air such that no air from these areas in the newly created protection zone (see drawing, area 1 ).

With the invention can thus be dispensed with an additional insulator module and the associated additional costs and the additional space requirement. This results in considerable cost advantages for the user.

Naming the cited sources:

• [1] "Annex to the Federal Ministry of Health's announcement on Section 2 No. 3 of the Ordinance on Drugs and Active Substances of 12 March 2008 (BAnz., P. 1217); Annex 1 to the EC Guide to Good Manufacturing Practice "
• [2] "Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice", APPENDIX 1: ASEPTIC PROCESSING ISOLATORS

Explanations to drawing 1:

• 1 - Exterior cleaning machine - inlet area as local protection zone
• 2 - mouse hole (isolator output)
• 3 - Isolator for aseptic preparation
• 4 - Input of the isolator (not shown in detail)
• 5 - Outside cleaning machine - washing area
• 6 - Exterior cleaning machine - Drying area
• 7 - Exterior cleaning machine - outlet area
• 
  Area with overpressure to the environment
• 
  Area with negative pressure to the environment
• 
  product path

Claims (1)

The invention is characterized in that 1. a cleaning machine arranged according to an isolator (see drawing, area 1 ) is equipped with a supply air system, 2. the supply air is injected into an inlet region of the cleaning machine, which on the one hand to the outlet of the insulator (see drawing, area 2 ) and on the other hand to the washing area of the cleaning machine (see drawing, area 5 ) has openings for the transport of sealed containers with product, 3. the area of the cleaning machine supplied by the aforementioned air supply system (see drawing, area 1 ) is operated with excess air, so that from the aforementioned adjacent areas no air flows into the area supplied by the Zuluftsystem area of the cleaning machine.

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