Iskra Pio d.o.o.

We offer complete construction of clean rooms, which means the production of floors, walls, ceilings, doors, windows and also whole ventilation system to ensure appropriate working conditions. We also produce different equipment for clean rooms like washbowls, wardrobes, waste baskets and so on. We are managing entire process of clean rooms, complete logistic of staff and material. All processes are monitored and regulated to ensure proper working conditions.

Our systems can achieve degrees of cleanliness from A to D according to GMP (100; 10,000; 1,000,000).

• Sampling booths

The room with a built-in booth provides clean conditions for sampling and the necessary safety to the operators and the surroundings. Usually, it is set as a separate unit located at the entrance of pharmaceutical materials into the production process. With its different grades it ensures clean conditions in the room which includes a sampling booth. It is adapted to the mode of material transport, sampling frequency and to the mode of operators' entry and work (hall, changing rooms, etc.).

• Weighing cabins

Weighing cabins ensure the protection of operators working with hazardous substances. Individual devices can be adjusted to desired technology. A safety clean cabin – weighing cabin is used for handling sensitive, health harmful dust substances. Weighing and dispensing is computerized and controlled according to the technological process, using specially designed equipment and automatic weighing machines.

• LAF units

A LAF unit is a self-standing device with a vertical laminar air flow, which provides protection of open materials in the working area. The protection offered by the device belongs to class 5 of ISO 14644 classification or to class A according to GMP guidelines.

• UDF units

UDF device is a self-standing device with a vertical laminar air flow. It provides protection of pharmaceutical processes carried out within the protected area of the device. The protection offered by the device belongs to class 8 according to ISO 14644 classification or to class D according to GMP guidelines.

• RABS systems

A RABS device is a self-standing device with a vertical laminar air flow. It provides protection of pharmaceutical process carried out within the protected area of the device. The critical part of the line where the substance and the packaging are exposed to contamination from the surroundings is washed with a HEPA filtered laminar air flow, generated by the RABS device over the line. The protection offered by the device belongs to class 5 of ISO 14644 classification or in class A according to GMP guidelines.

• Personal barriers

Personal locks presents barrier between two differently clean areas. It is designed like a transition cabinet with interlock system for intensive air-washing and securing safety conditions during in/out personnel. For more intensive leaching a"mist shower" (shower with water fog) is used.

• Material barriers

Material barriers enable transfer of pharmaceutical material and equipment between rooms with different air classification and pressure. With controlled interlock the material barriers prevent irruption/contamination of air from less clean into clean room and opposite. We develop different types and shapes of material barriers: Passive and Active pass-through box, De-dusting cabinets, possibility of sterilization with UV light or VPH/H2O2… They are designed and made according to GMP directives.

Validations

Validation of clean rooms and equipment is performed to confirm clean and safe working conditions.

• Particle counting, room classification
• Airflow volumes, air change rates
• Airflow velocity measurements
• Filter in place integrity test
• KI-DISCUS test
• OEL level test
• Temperature test
• Relative humidity test
• Room pressurization test
• Visual smoke test
• Recovery time test
• Light level test
• Noise level test

Isolators ensure the highest level of protection for the operator, product and environment and are suitable for handling the most dangerous substances or protect most sensitive process. Operator and process are separated by physical barrier and controlled pressure inside Isolator. Environment protection is assured by exhaust air HEPA filtration. Product protection is assured with inlet air HEPA filtration, physical barrier between operator and process and controlled atmosphere inside isolator.

Our experiences in isolator development and manufacturing technology allow us to offer isolators which will provide safe and sterile work environments for manipulation with hazardous/sterile materials. Isolators are intended for packaging, sieving, sampling, weighing and other manipulations of pharmaceutical materials under certain conditions (sterile, inert atmosphere,… ) or work with hazardous (microbiological, OEB3, OEB4, OEB5) materials.

Our isolators offer innovative solutions in material transfer in/from working chamber, without braking conditions inside the isolator. According to different sizes and shapes of inlet/outlet packaging, we have developed multiple solutions (multiple drum ports, CLS ports, pass through chambers, pressure equalizing chambers…), which assure efficient transfer of used packages.

Working chambers are made of stainless steel quality 316L with surface roughness upon request (brushed, polished…). All corners of working chamber have suitable radius that enable easy cleaning. Working chamber design enables operator to reach all corners with gloves (for cleaning) and has all equipment on desired place. Front glass with typical 8° inclination from vertical assures comfortable working position. The glass is made of tempered safety glass and is hermetically sealed to working chamber. Gloves are placed on elliptical openings on front glass - glove is changed without opening isolator to environment. Systems typically allow safe glove and filter change.

Isolators are typically controlled through HMI which is located on easy accessible location. On the main screen of the panel  basic parameters, process quantities and regime of machine, which make machine easy to use, are given. For a more detailed view on machine functioning are foreseen quickly accessible screens like P&I scheme of machine, Trends of process quantities … The control system assures reliable maintenance of required conditions, safety of operator, process and environment and compliance with EU and US regulations (CFR part 11). All critical process quantities (P, T, Rh, H2O2 concentration, H2O2 consumption and remaining quantity, air velocity inside chamber…), can be monitored on HMI and report can be printed. In case of inappropriate conditions, alarms are triggered, shown on HMI and written in report.

In cooperation with the customer we develop different types of isolators, regarding customers needs and requirements (sampling, weighing, dispensing, sterility testing…). Dimension, shape, number of gloves, additional equipment, and atmosphere is adjusted to planned work and are finally determined on real size steel MOCK UP model. With our experience we can offer equipment, which will be the most suitable solution for customer’s needs.

Possible options:

• VHP sterilization system
• ATEX execution
• Particle counter
• Microbiological air sampler
• Specific atmosphere controls (T, Rh, O2…)
• Spray gun
• Weighing scales
• Equipment for supervision and control of weighing process
• Welding tongs - Device for sealing bags
• Glove testers
• Shelve holders
• Safe waste removal - Continuous liner system (CLS) or DTPE port
• Lifting system
• Drum clamping and tilting mechanism
• Needle for purging with nitrogen
• Platform for operator
• Zip bag system
• …

Material handling systems include equipment for processing of raw materials and are designed for different operations: mixing, grinding, seeding, dosing, weighing, washing, drying... With our material handling solutions we help our customers increase their productivity. Our highly trained engineers are experts in these areas and can find the best solution for your production.

• Container mixer

The container mixer is designed for mixing the powder container contents. It is suitable for mixing powders, granules or pellet. At the customer's request we develop a mixer according to customer needs. Controller and control system for parameterization, monitoring, triggering and alarm management is in accordance with CFR Part 11.

• Twin lifting system

This system is purposed for preparation of different mixtures. It is designed for the integration of required equipment for grinding, milling, seeding, dosing, weighing… The equipment is designed universal and capable in one place with the same controller control system to perform all these operations. The raw material is loaded from the floor, lifted and moved from higher to lower level by gravity through the various stages and equipment. The processing equipment is easily exchangeable. Two lifts with synchronous operation and cleanable design (without platforms…) assure effective and easily cleanable material handling.

• Automatic filling line

AFL is intended for filling containers with different starting package. This process controls filling of storage containers. Storage containers are raw material containers that are filled with raw materials from different types bulk packages (big-bags, drums...).

• Automatic weighing line

AWL is intended for the manufacturing of dosage raw materials. AWL consists of filling storage containers, located on a lifted platform. Batch IBC is located on a mobile trolley under the IBC platform. This IBC is filled with raw materials from the filling storage containers according to the received data. Weighing procedure is fully automated.

• Lifts and manipulators

The lifting device is used for lifting, turning, dosing, weighting and positioning of various carriers of material over the targeted devices. Iskra PIO produces multiple executions of lifts:

1. Pillar lifts for IBCs and drums (with automatic positioning, automatic valve opening, pneumatic hammer, IBC orientation detection, weighing scale, ATEX execution…)
2. Hanged lifts for containers and drums
3. Mobile lifts

Manipulators are devices that replace manual work. For these purposes we offer:

1. Hopper, which is located on the weighing cells
2. Weighing platform for containers and barrels
3. Trolley for washing the funnel
4. Equipment designed according to customer specification

• Washing and drying

Drying takes place in the chamber, where certain conditions are ensured (temperature, moisture, clean conditions, etc…)

Drying is performed with the help of dry hot air, which is blown into the chamber through the nozzles. AHU which is located on the technical floor, takes care of the adequate preparation of the air. The drying chamber and the AHU are interconnected with ducts. Filters (F9 and H14) in AHU and the drying chamber, ensure the appropriate level of cleanness within the drying place.

• Mills & Micronisers

Mills are used in pharmaceutical processes to increase surface area and improve formulation dissolution properties. Size reduction is one of the most common unit operations for active ingredients (API's), as well as bulk pharmaceuticals (BPI's) and others. Iskra PIO integrates mills according to customer’s requirements (mobile execution, with inertization, ATEX…).

• Sieves

A sieve is an essential part of every pharmaceutical production process, particularly as product quality and integrity are so important. Our equipment is available to meet your capacity and configuration needs. Iskra PIO integrates sieves according to customer’s requirements (mobile execution, with inertization, ATEX…).

Safety cabinets are researched and designed by our experts, based on long term experience in the development and production, they  ensure the highest level of protection for the operator, provide clean working conditions and protect the environment from contamination. Operator’s safety and comfort are paramount. Standard products of our company are different types of laminar flow cabinet that enables clean working conditions. There are different versions available, so buyers can modify the product's functionality to their wishes and needs. At the buyer's request, we can also create products of unique dimensions and characteristics.

Basic characteristics:

• built in accordance with GMP, GLP standard
• easy for cleaning and maintenance
• easy disinfection
• rounded corners
• easy and safe filters replacement
• low noise fan
• progressively adjustable fan
• available in different sizes
• easy accessible electric section
• stainless steel or metal construction protected with powder coated
• operating and safety features controlled by microprocessor (alarm limit values)

Protective class I

• MC – 1; Protective laminar vertical work-bench

A work-bench ensures the highest level of protection for working product from contamination. Inside working space is established laminar airflow and clean space conditions in class ISO 5 (ISO 14644-1) or class A (GMP).

• MINI – S; Mini vertical work-bench

A vertical chamber type MINI is a desktop version with vertical air movements and is designed specifically for smaller, simpler tasks that require clean working conditions. It is designed for the work in a pharmacy and in the field of pharmacy industry, microelectronic, optic...

• DIG; Suction work-bench series

It provides safe working conditions for the personnel and protects environment from contamination without dangerous emissions at working place. Air is drawn in from the front (open) side of the cabinet, and expel the air directly to the exterior of a building.

• OK; Extraction-protection cabinet

Exhaust chamber for safety manipulation with danger active substances (weighing, sampling or another laboratory work). Anti-vibrational working desk is made of black granite and is because of horizontal laminar air flow appropriate for precise weighing (0,1 µg). The surface is protected with an anti-absorbent surface layer.

• PCR; PCR work-bench

Intended for the safe handling with dangerous pharmaceutical substances.

 Protective class II

• MC – 2; Microbiological safety cabinet

The microbiological safety cabinet assures a high level of safety to the operator, the surrounding and the product. Cabinet is manufactured according to the requirements of the standard SIST EN 12469:2000 – measures for microbiological safety rooms.

• MC – 3; Cabinet with triple hepa filtration

This type of cabinet has an integrated additional set of absolute filters below the working segments. They protect filters above the working area and exhaust filters so those filters which are not subjected to the contaminated dust particles and consequently to replacement because of particles overload. Filters below the working segments can be replaced within the work area while the cabinet is running in working mode.

• MC – NC; Cabinet with 100% fresh air

The bench has 100% in/out air current. The exhaust air is directly connected to the independent AHU system with additional HEPA filter. Two fans inside bench and filters system assure safety conditions for operator, product and environment.

• MC – PB; Isotope – safety work-bench

The safety cabinet type PB (safety class II – SIST EN 12469:2000) assures operator’s, product’s and environment’s protection during working with radioactive substances, it is covered with 4 mm lead frame (or more if required).

The ultrasonic cleaner is designed for cleaning, degreasing, degassing, homogenizing etc. For cleaning or degreasing use water medium with an addition of proper detergent. In pharmacy, it is used to clean different manufacturing unit parts in contact with the product. For cleaning there is also a special holder available, for small parts a rack is used.

An ultrasonic cleaner consists of bath, housing and cover, all made of stainless steel. An ultrasonic generator is a set of electronic circuits which change electric energy into high frequency electrical energy. The basic concept behind the design of the PIO generator is that it always guarantees the maximum performance. The mechanical efficiency of ultrasonic cleaning can vary in accordance with a number of factors such as:

• temperature of the liquid,
• density of the liquid,
• surface tension.

This efficiency is also an effect by the shape and weight of the parts to be cleaned as well as by the depth of the liquid in the tank. The choice of a cleaning product use is also an important factor. The brain of this machine made up of a set of the latest and most sophisticated integrated circuits constantly monitors and regulates the ultrasonic oscillating frequency whatever the above parameters, so that there is always maximum cavitations power in the tank.

A “frequency sweeping” system prevents the formation of zones more liable to cavitations or shadow, ensuring uniform cleaning of all of the pieces surfaces.

This technology has the advantages of piezzo-electric transducers, without any disadvantages:

• highest possible efficiency,
• can tolerate high capacity without danger of damage from over loading,
• homogeneous frequency distribution over the whole surface,
• high quality output does not diminish with time,
• the ultrasound, is spread in a wide range.

A generator is equipped with RFI filters and corresponds to international IEC security norms.

All internal and external surfaces are manufactured according to pharmaceutical requirements, and they must be accessible and easy to clean.

A digital thermostat and timer reads and maintains a constant temperature and working time. Regulation, heating, start-up (timers) and all digital indicators for adjustment are located on the control panel. The components are made of high reliable European quality products.