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Aseptic processing of HPAPIs using Dec PTS

products-servicesDec Group
September 7th 2016

Aseptic high-potency API (HPAPI) processing calls for specialized facility design to help pharma improve and maintain the sterility of their drug products and protect staff.

Achieving high containment levels to minimize operator exposure whilst protecting sterile products is a complex process in which nothing can be left to chance.

An effective solution can be constructed the Powder Transfer System (PTS) technology with a sterile high containment powder dispensing and charging isolator designed by Dec Group. This avoids the necessity for costly clean room construction.

The solution is well illustrated in a recent case study featuring an animal health pharmaceutical manufacturer using sterile high containment powder dispensing and charging using PTS Powder Transfer System and a purpose built isolator.

Background

Maintaining 100 per cent containment in sterile handling of highly potent-compounds usually demands specialized equipment and facilities, including costly fixed or mobile cleanrooms, Restricted Access Barriers (RABs), laminar flow cabinets or glove boxes. Ideally, the chosen equipment should not only be totally fit for purpose but also sufficiently flexible in use to allow easy process changes, especially in multipurpose facilities.

DEC Poland Integrated Isolator from Powderhandling on Vimeo.

For these reasons, the use of isolators presents a more accessible and versatile option increasingly favored by manufacturers.

Dec Group recently worked in partnership with an animal health drug manufacturer to construct a solution using patented PTS technology to handle powder dispensing and charging under high containment, using a twin chamber isolator.

Requirements

The customer needed to charge a reactor with sterile high potent ingredients while assuring complete operator and product protection.

The system had to meet a series of crucial requirements:

  • OEL (Occupational Exposure Limit) of < 1 µg/m3 time weighted average (TWA) over eight hours
  • Ensure safe barrier between the operator and the active drug substance to ensure both operator and product protection
  • Achieving and maintaining an ISO 14644-1 class 5 environment for particles and viable micro organisms
  • Plant designed to operate in both positive and negative pressure modes and in sterile and non-sterile conditions
  • Multi-product use of OEB 5 category (sterile potent compounds)
  • Clean or sterilize in place (CIP/SIP) with temperature mapping

Solution

Dec’s process containment experts designed high level environment isolator as an L-shape twin chamber isolator consisting of a fast gassing airlock and a main charging chamber, connected via an internal transfer door. The system is designed for the charging of either sterile or high potent compounds supplied in various number of bags of different sizes and weights max 15 bags x 10 kg into a process reactor by means of PTS Powder Transfer System.

For utmost cleanliness the isolator features a through-the-wall design creating a dedicated technical area for maintenance and services at the rear of the system, which is accessed separately to the process area. The process operation mode is selectable either in positive or negative pressure via the operator interface (HMI).

Advantages

The solution offered a series of customer benefits:

Sterile mode operation – Both chambers are initially loaded with bags of sterile APIs in various weights and sizes through the front visors. Both visors are then closed and the isolator environment started. Prior to commencing production an automated pressure decay test is performed. The operator then removes the outer foil bag from each bag, which are disposed via a non-sterile endless liner in the airlock. Each bag is then hung in a specific validated position using Dec’s automated bag rack system.

Total decontamination – Both isolator chambers are then biologically decontaminated using Vaporized Hydrogen Peroxide (VHP). This process achieves a 6-log reduction by means of a validated decontamination cycle and an integrated open loop VHP generator. Once bags are sterilized they are removed from the rack and those from the airlock are transferred into the main charging chamber. The internal transfer door is then interlocked closed.

Transfer under containment – The weight of each bag of powder is then manually verified on an internal scale prior to manually opening the bag and manually charging the sterile APIs into a pre-sterilized (with clean steam) powder transfer hopper. The APIs are then conveyed into a sterile process reactor using Dec’s patented PTS Powder Transfer System, which is installed directly on the process reactor in an adjacent vessel room.

Maintaining sterility – To meet campaign requirements, the above process can be continued by using the airlock as a fast gassing airlock with internal transfer door between both chambers interlocked until the next VHP cycle has been completed. This enables the charging chamber to remain sterile at all times.

Potent mode operation – for highly potent products, the same process is followed but with isolator operating under negative pressure. There is no requirement for biological decontamination of the incoming product.

However due to containment in this mode, the main charging chamber operates at a lower negative pressure than airlock, with the latter operating as a conventional transfer airlock chamber.

PTS Powder Transfer System

PTS is a system for conveying and dosing of dry and wet powders and granules. In order to convey powder, the system operates with vacuum and pressure. It is composed of a cylindrical body that is alternately filled by vacuum and discharged by pressure. A flat filter membrane in the upper part prevents fine dust particles from entering the vacuum line. The membrane is cleaned by each discharging cycle by means of sterile compressed air or inert gas.

The PTS transfer system including charging hopper and transfer hose to the process reactor can be sterilized in place (SIP) with clean steam with full thermal mapping. This assures sterility throughout the whole dispensing and charging process.

With safety being a large issue in today’s industries Dec offers more than a complete range of high-level process containment solutions for the pharmaceutical industry. It adopts a holistic approach providing a comprehensive range of services such as industry expertise, testing facilities, safety and regulatory advice, IQ/OQ and validation as well as global service capabilities.

Resources

Click on Powderhandling to see video.

Aseptic processing of HPAPIs using Dec PTS

Arrangement of Dec’s high containment sterile dispensing isolator (left) and reactor charging area (right) connected via PTS Powder Transfer System for a closed and sterile process flow

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