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Pharmaceuticals

Pharmaceuticals · Dycem


 Contamination Control for Pharmaceuticals  Contamination Control for Pharmaceuticals 2  Contamination Control for Pharmaceuticals1

Pharmaceutical Environments are both complex & diverse, ranging from Sterile Vaccine Production to Multi-Vitamins including levels of mass/batch production / packaging needs in between.

As a result, the risk of contamination is also both complicated and varied where control is differentiated by classification levels as much as it is by demand, driven by changes internally and externally.

One element that sticks true is the irreversible, negative impact contamination (viable or non-viable) has over the products, processes, yield and brand if not properly supported with the correct solutions at the appropriate levels.

95% off all Pharmaceutical Environments are generally categorised in the following 4 sub-levels: Sterile, Cleanroom Controlled, Controlled Not Classified (CNC).

Their levels are driven by the sensitivity of their production as much as the content it produces.

Facilities will look to ensure the necessary protection across all surfaces, looking to keep up to specifications with standards and regulations.

Guidelines in place to support benchmarks in contamination control at micron levels Drugs and ISO information from the FDA are widely followed and reverted too.

Surface contamination control in Pharmaceuticals is paramount and the risk of exposure at floor level is both the largest due to the surface coverage and the hardest due to the flow of differing variables such as human, wheel and material effecting the situations faced.

Further evidence suggest contamination control at floor level, as much as at other levels, requires a revised and more active focus from all facilities in the above conditions as a innovative USP in the prevention of microbial and foreign particle cross contamination risk.

With increased capacities and increased volume of traffic, especially consolidated traffic of wheels and pedestrians within different CNC-ISO zones, the need to support with validated and integrated solutions that offer a proven performance in control is widely noted.

As a concept, Dycem is the leader in floor surface contamination control and has proven over the last 30 years within the Pharmaceutical industry, that our systems offer the most complete and sustainable solutions for an ever changing industry.

Already serving approximately 50 top Blue Chip Pharma facilities worldwide, our Dycem Contamination Control Floor Mats and services, offer a proven contamination control solution for all types of production (CDMO, Sterile, Vaccine, Powders, Liquids, Semi-Solids, Blister Packaging, Softgels, API’s, Nutraceuticals) and all share a common placement of our Fixed and Loose based solutions:

Where we can help

The commonalities in area placement are not subjected to a fixed solution. Our diversity is customisation, installation method, size differs depending on critically, volume and aesthetics.

  • Gowning rooms/ Pedestrian Airlocks
  • Material Airlocks / Warehouse Entry
  • Primary Packaging / Assembly
  • GMP Entry / Exits to Production
  • Granulation Bays (ATEX support)
  • Fill and Finish
  • Microbiology Laboratories
  • Sterile ISO 3-4
  • CNC environments

From start to finish – Full cycle control

When you are using raw materials

Raw materials have the potential to be contaminated by environmental factors or human error, which could lead to the materials being contaminated, mixed up or most importantly, contamination being brought in from outside spaces, leading to the introduction of foreign bodies being introduced to the manufacturing process.

The pharmaceutical industry faces multiple constraints and has different specialties, making it completely unique in comparison to any other industry types.

The industry needs extreme care in each step ranging from collecting the raw materials, to get in hand the product ready for supply.

Powder transfer is highly sensitive in some productions as many multi-batch production is now a common practice.

The risk of dust/powder explosion caused by static charge build up between particles is well documented, with extreme care and due diligence taken to try and prevent it, especially through wheel traffic activity from items such as a forklift or pallet truck.

You can find out more about dust explosions here

That is why it is highly important that you have clear contamination control protocol in place at source to prevent risk from entering and adding to this sensitivity.

Adapting an approach using Contamination Control systems from Dycem will allow you to support and control at source the risk of cross contamination, viable or otherwise, supporting an unavoidable barrier with proven anti-microbial and static dissipative benefits to the users operating in a 24/7 environment.

Your Environmental Sources and Monitoring Them

Monitoring your environmental sources and testing equipment could be affecting your contamination control procedures within your pharmaceutical cleanrooms and other controlled environments.

Environmental factors can have a severe impact when it comes to keeping control of contamination and contaminants entering your clean and sterile areas.

They could be coming in via your clothing, incoming air ventilation, machinery and other equipment in or nearby the clean or sterile area.

However, other things, such as a poor heating and ventilation system (HVAC system) can also be a potential source of microbes growth and a transportation mode for dispersing contaminants throughout the manufacturing facility.

Accumulation of organic material in or near HVAC air intakes coupled with Ineffective filtration of the supply air can really damage your product’s credibility.

Alongside the Inability for a HVAC system to access ventilation dampers and filters from outside the manufacturing areas and non-directional airflow within production or primary packing areas, your protection from contamination will start to reduce to undeliverable and unacceptable standards.

Placing a Dycem mat is proven to be a supportive and synergistic, added value process to a reduced airborne count whilst supporting a much more sustainable outlay vs alternatives.

Cleaning Equipment

Introducing equipment to your clean, controlled or sterile areas increases the risk of your pharmaceutical products becoming contaminated from an external source.

Improper cleaning and sanitisation protocols could harm your products, causing increased spoilage issues and a prevention of proper cleaning and maintenance procedures being carried out at your facility.

The accumulation of static material, lubricants, coolants, dirt, and sanitizing agents being introduced by or as a result of your cleaning equipment entering your controlled vicinity could have a massive impact on production and quality of your pharmaceutical products.

At Dycem, our mats and flooring are tailor made and fully adaptable to you cleaning SOP and protocols.

Compatibility and “red tape” avoidance is critical for a smooth process in between shifts. Cleaning must remain a simplified process and avoid downtime to production.

Dycem’s ability in retention and overstriking capabilities allow it ( in the right placement) to support a reduced but complete cleaning operation.

Packaging and repackaging Areas

Packaging and repackaging in pharmaceutical areas have a range of important uses.

As well as being used to store and protect drugs, packaging pharmaceuticals is also essential for identification purposes, for marketing and promoting different brands, and for facilitating the use of pharmaceutical products.

No matter whether your pharmaceutical product is, classified as primary, secondary, and tertiary, it is essential to ensure strict procedures are followed and correct protocol is adhered to avoid contamination.

Within the packaging an repackaging areas, cartons or boxes, vials, bottles, blister packs, sachets, syringes and ampoules all need to be fully compliant and meet to regulatory standards that make them suitable for use.

Dycem’s WorkZone flooring solutions offer superb support in large particle collection, debris and wheel containment in these areas, mostly known and grey zones.

Processing departments

There are various opportunities for contamination to enter the Pharmaceutical manufacturing process.

Lack of dedicated facilities to manufacture a single product and the inappropriate cleaning in-between batches, disregard of an area line clearances according to approved procedures following each cleaning process and between each batch and lack of communicative cleaning procedure and labelling can all play a key part in allowing contamination to enter.

The use of an open manufacturing in the processing on pharmaceuticals could also be exposing the product to the immediate room environment if inappropriate zoning is not being correctly used.

Dycem floor mats offer a two-toned system approach and, are available in a range of colours to help with zoning and ensuring strict protocols are met.

By utilising our flooring in your sterile through to your controlled areas, you stand a better chance of inhibiting the growth of contamination in your facility, whist reducing the risk of contamination effecting your products.

In your Storage areas

It is well known that all materials and pharmaceutical products in storage areas should be correctly labelled and stored correctly to a standard which does not adversely affect the products and provide adequate protection for the products.

Segregation of batches in your storage areas although necessary, cannot be guaranteed.

Poor practices in your storage areas could result in infiltration of certain contaminants and microbes into your stored items and products.

Dycem’s unique and unrivalled technology in your storage areas and using our two-tone approach will help you segregate your areas and enable you to have control of contamination that may be prone to enter.

Transportation of Your Goods

The transportation of your pharmaceutical goods on arrival to your facility, is a carefully thought-out procedure.

Each incoming delivery should be checked, and each container physically verified and examined to ensure correct stock has been delivered and nothing improper has happened to the product during the transportation procedure.

Using Dycem adds safety and assurance to this procedure. Ensuring your products are adhering to the strict regulation from storage, right through to delivery.

Production Capacity Increases

Increasing production at your pharmaceutical manufacturing plant is a positive step in increasing your product revenue and is the sign of a positive product.

However with this positivity also comes caution.

If there is need for updating or increasing capacity of production within your pharmaceutical plant, it is essential that correct compliance guidelines are followed even more so than before.

Increase in production is equal to an increase in risk, so therefore having correct contamination control procedures in place and in the right areas will allow for a fully functional process and a smooth transition into your new expansions.

Dycem have worked with various companies worldwide, who have increased their capacity and chosen us to help ensure all decontamination protocols are met and all industry and product guidelines are followed.

Our Validation, Compliance data, Testing

At Dycem we have always endeavoured to develop high-quality products and services that ensure customer satisfaction is achieved and, wherever possible, exceeded.

This commitment to ongoing improvement is ensured with the company ensuring a management system that conforms to the relevant national and international requirements within the Pharmaceutical industry.

Our production processes are continuously monitored to make certain that products meet document requirements and that the products delivered to our customers conform to all relevant standards of the industry.

We guarantee quality focus exists throughout the organisation, from product development, through manufacturing, to the delivery of our products.

PHARMACEUTICAL COMPANIES WHO USE DYCEM

CASE STUDIES

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