Many circumstances like cleanrooms require an area to be free from microbes and impurities. This place cannot afford to have even a particle those. Many people part of cleanroom walk carelessly inside the isolated area with their shoe carrying impermissible impurities. So, care must be taken by clean room sticky mats.
Sticky mats are nothing but compressed layers of polyethylene film. They come in bundles 1/8th of an inch thick with up to 30 sheets in a packet, and are available in a variety of colors and sizes. Sticky mats are meant for the purpose of collecting dirt and debris from shoes as they come into contact with a walker’s feet. When the top sheet becomes filled with too much dirt, you can simply pull the tab at one corner and discard the old sheet for the clean new sheet, the one below it. There is an adhesive double sided strip on the bottom of the packet. Once you remove the protective covering, you place the pad on the area you want to protect and you are ready to use it.
Sticky mats were developed predominantly for use in clean rooms that require sterile environments. The adhesive covering the mat works well to remove dirt but it also is treated to inhibit the growth of bacteria. It’s a remarkable invention in terms of essential component of cleanroom. It avoids the chance of dirt or any sort of microbial contamination.
With the advent of technology, many aspects of Pharma industry have advanced. One such aspect is to come up clean and microbe-free products in the market. For that same fact, Clean rooms have got utter importance to maintain the value of cleanliness to produce expected product with quality.
A new type of product used in such clean rooms like austenitic stainless steel came up in market, especially designed which is known to have more durability and resistance to bacteria. It has been developed by technologists at the University of Birmingham (UK). It making involved adding silver or copper to the surface of steel using the technique of ‘active screen plasma’ASP technology.
Since, Silver (Ag) and Copper (Cu) have a long history of use in human healthcare and medicine. It is known to be poisonous to bacteria just as lead or cyanide is to humans.
Hanshan Dong, the lead scientist in this area, took this existing ASP technology, a plasma surface engineering method used to harden stainless steel and came up with unbelievable process which introduces silver along with nitrogen and carbon, into the steel. Silver acts as an antibacterial agent and nitrogen and carbon adds to the steel’s hardness and durability.
The researchers treated stainless steel medical instruments 120 times, multiplying the cleaning process in hospitals. They found this ASP technology and this antibacterial properties of the stainless steel were still intact and the surface still resistant to wear. They look promising and marked itself for longer duration of time.
Resource: HVAX Technologies
Clean rooms in Pharma laboratories and various FMCG industries need to maintain certain quality of air to meet their needs of cleanliness or inhibit any kind of micro-organisms in the vicinity.
Even the person in the lab has certain value of microbes on their skin especially hands which could be readily transferred in to the product or critical area or objects if not taken with enough care. Such microbes are either present on the skin not multiplying like pre-existing flora, which can include a wide range of environmental microorganisms like Staphylococcus, Pseudomonas etc or are multiplying microorganisms released from the skin like residential flora coming from the families of Micrococcus and Propionibacterium. Of the two groups, residential flora is more difficult to get rid of. For utmost important operations, some protection is taken by wearing gloves to inhibit these creatures. However, gloves are not suitable for all activities and you have to undergo frequent sanitization or if they are of an unsuitable medium they will catch up and transfer via cross contamination.
Considering all these value points, sanitization of hands and surfaces in healthcare settings and in cleanrooms is of extreme importance while dealing with bulk drug production or any research which involves lots of effort and time, as carelessness at any point of operation could cost the company heavily.
The cleanliness of sterile clothing is an important consideration in order to prevent the clothing itself to become a source of contamination. For example, sterile gloves that have been washed in de-ionised water, cleanroom packed, sterile validated and specified for low endotoxin levels can help lower the risk of particle, microbiological and endotoxin contamination.
Sterile apparel that is laundered, cleanroom packed in individual vacuum packaging, double-bagged and provided with periodic sterile validation will also contribute to lower contamination risks. Sterile gloves made from synthetic materials are beneficial because they can eliminate the risk of contaminating the final product with rubber latex proteins, which can be a problem for patients with latex allergies.
Another point to keep in mind is the barrier performance of the clothing. Continuous improvement can come from better control or elimination of variability in attributes that impact barrier performance. For example, disposable apparel eliminates the risk of variability in filtration efficiency and material strength that may come from re-wearing, re-washing and re-sterilizing apparel many times and over a long period of time. Sterile apparel made from stronger materials and sterile gloves with a higher quality film formation will be more resistant to breakage and are more likely to be free from any pinhole type defects.
As well as protecting the process from contamination, sterile clothing should also protect the wearer from the health and safety risks presented by chemicals. Sterile gloves tested to show longer resistance times to permeation by cytotoxic chemicals and sterile clothing certified to provide protection against chemical splashes can contribute to better protection for the wearer. There are also other ways to protect wearers from health and safety risks. For example, sterile clothing that is bio-compatible can mitigate the risk of the clothing causing irritation to the wearer, and sterile gloves that are free from natural rubber latex will eliminate the risk of latex allergies.
Maintaining sterility and contamination control are important factors in any of the pharmaceutical industry. Most, if not all chemicals naturally contain some degree of contamination, however, even low levels of contaminants can be expensive or possibly hazardous.
In cleanroom labs, the unlikely presence of contaminants can call surprise reactions and deviate from actual results. In drug/ medical equipment manufacturing, contaminants can include toxins that convert a medicine into a poison, while infected medical devices can transmit pathogens to patients.
People came to different ways to manufacture contaminant-free products, ranging from sterilization to containment and contamination control, depending on the degree of sterilization you require. Often this combination works well both in terms of safety and efficacy.
Limiting the contamination leads to various options available in the market. From laminar airflow, sealed transfer hatches to disposable containment systems for individual processes. They provide complementary protection against infection and avoid cross-contamination.
In the pharmaceutical industry, decontamination is the first step to proceed further. Everything from laboratory instruments to glassware and processing equipment should be sterilized. All the glass wares are sterilized in the lab with the help of autoclave. Other options include dry heat sterilizers and chemical vapour sterilizers (often using hydrogen peroxide vapour – HPV). HPV decontamination systems involve the release of hydrogen peroxide vapour (H2O2), a powerful disinfectant that combats viruses, fungi and bacteria.
Cleanrooms provide an isolated, ventilated area for safe handling of chemicals and biologicals. Cleanrooms cannot prevent contamination altogether, but help to keep contamination to a limited level, protecting cleanroom products from contamination from the environment, safeguarding chemists and researchers against hazardous chemicals and biologicals in the cleanroom, and sometimes protecting the environment at major level from hazardous substances and pathogens.
Cleanroom is an isolated environment where products are manufactured. It is a room in which the concentration of airborne particles or micro-organisms is controlled to specific limits.
Contamination control is the biggest task to be taken care of in a clean room. They are ubiquitous and they come from people, process, facilities and equipment. They must be continually removed from air. The level to which these particles need to be removed depends upon the standards required for that particular industry. Strict rules and protocols are followed to prevent contamination of the product.
Contamination is taken care of by controlling air flow rates and direction, pressure, temperature, humidity and specialized filtration.
Clean rooms are designed and manufactured using strict protocol and methods. They are frequently needed in industry of electronics, pharmaceutical, biopharmaceutical, medical device industries and other critical manufacturing environments.
Contamination could cost you an arm and a leg. Product manufactured in that period of time (whole batch) just goes to waste.
For the same, different industry has a different quality of cleanliness. There are different grades of clean rooms. A Class 100 cleanroom is designed to never allow more than 100 particles (0.5 microns or larger) per cubic foot of air. Class 1000 and Class 10,000 clean rooms are designed to limit particles to 1000 and 10,000 respectively.
By the end of the day, after a clean room is done, the next big thing remains is to maintain a clean room with all the given standards and to get superior products.
ranges from full turn-key design/build to plan & spec construction. It’s a potential manufacturer of pre-engineered, pre-fabricated modular partitions/panels and doors for building infrastructure. Recently we have also shifted our focus into manufacturing of economical internal panels for non-pharma companies.
Company also designs, fabricates, integrates, installs and services highly technical custom built Isolation/Containment Systems for pharmaceutical and biotech industry.
Design Engineering & detailing
We are committed to provide total solutions in the areas of Clean room equipments. We are also involved in refrigeration facility design, execution and qualify to serve quality conscious clients who desire to have correctly optimized facilities.
These activities are carried out and coordinated by a team of professionals assisted by a group of associates, who have a wide-range of exposure in various aspects of Pharmaceutical Operations, Facility Design and Project Execution.
Parameters for designing clean room:
- Air leaks through the walls around windows, piping etc.
- Air filters leaks in gasket and in the filters itself.
- Filtration efficiency of different filters.
- Fire proofing of material construction.
- Wearing resistances of surfaces.
- Air movement in the clean room.
- Concept development, feasibility study and front-end engineering.
- Process engineering and material flow control.
- Clean room facility as Per USFDA/WHO/UKMHRA
- Non-Clean Utilities like Potable Water, Plant Steam, Water Pre-Treatment Systems, Non-lubricated CA systems etc.
INSTALLATION VALIDATION AND QUALIFICATION
Validation and Qualification is the process of proving and documenting that the system performs as per the design specification and the Client’s User Requirement Specification (URS).
ECS contractor entailed the following aspects:
- Air balancing
- Room air change rate calculations
- Room pressurization measurements
- Filter integrity (DOP) testing of HEPA filters
- Room particle count testing
- Control system software functionality tests
- Instrument calibrations
- Room temperature monitoring
- Room relative humidity monitoring
- Maintenance procedures
The Operational Qualification process verified and documented that the systems operated within the required limits and tolerances and that the systems complied with the design requirements.
- General specification and compliance check.
- HEPA filter leak test
- Factory ducting post welding leak test
- Room differential pressure test verification
- Particle test for cleanliness
- Air pattern smoke test
- Light intensity test
- Noise test
- Air velocity test
- Air temperature and RH tests
- Room pressure gradient including the system capability to avoid decay of negative pressure.
- All the conditions, class of cleanliness, air pressure gradients, temperature and RH and other parameter shall be ensured during the operation of the laboratory.