“The Total Service Provider to the Regulated Industries”

“The Total Service Provider to the Regulated Industries”

“The Total Service Provider to the Regulated Industries”

We measure our success by your success. This defines the difference between IPS and our competitors.

Offering the specialist skills required to handle even the most complex of projects, from design to completion, we provide our clients with the optimum in quality of finished product, speed of delivery and value for money.


Our Approach

Here at Integrated Pharma Services we pride ourselves on being the “total service provider” to the Regulated/Life Science Industries.

We offer all the specialist skills required to handle even the most complex project from design to completion. Measuring our success by your success, we offer a single point of contact to provide our clients with the optimum in quality of finished product, speed of delivery and value for money.

Our Aim

Your project will be successful by design, not by chance.

With a genuine focus on developing close partnerships with our clients underpinned by our non-contractual ethos, we can implement complete projects from initial feasibility through to the completed facility, or if appropriate can integrate with an existing team to enhance capabilities in more specialised areas of facility design, construction, engineering or validation.

Who we are

Integrated Pharma Services Limited are a highly skilled team providing bespoke “single stop” solutions tailored to the exact needs of our Clients. We offer a wide range of working practices to take care of as much or as little of your project as you require.

Integrated Pharma Services Limited was established in 2006, and our mission is to provide an extremely high quality of service to the Regulated Industries.
Establishing long term relationships with clients based on mutual benefits and trust, all our people are committed to improvement and we constantly monitor our performance to ensure we are providing the best possible service.

Our success is underpinned by a team of motivated, proactive and talented individuals who provide the core to the success of the practice and to all of our projects. We believe that our staff are our greatest asset and promoting honest and open communication is the key to encouraging ownership of the company’s beliefs and principals.

Projects / Placements

Serialisation

Following the Falsified Medicines Directive (FMD) Safety Features Delegation Regulation, serialisation of licensed drug products will be a legal requirement from early 2019 (for manufactures supplying the EU).

IPS is undertaking the full Management of an upgrade scheme, which includes the complete upgrade of existing equipment of Blister, Bottles and OCL lines.

Our dynamic approach to ensure each element of the project is undertaken with precision and integrity has enabled our team to seamlessly integrate within our client’s requirements.

Full installation and qualification (up to OQ) has been completed on one blister line and the remaining lines are scheduled for completion in 2018.

The work will also include the installation and qualification of the Level 3 site server as we as connection to the Level 4 repository.

Ointments, Liquids and Creams Projects

IPS has lead projects generated as a result of several new product introductions (NPI) to existing clients, requiring the purchase and validation of new mixing and filling equipment.

The mixing vessel systems have varied in complexity depending on the composition of material (i.e. solution, suspension, creams, emulsions etc.) from simple variable speed impeller mixers to combinations of impellor, paddle and homogeniser mixers. Additionally, jacketed vessels have been used where temperature control is required and load cells added over a range of accuracies dependent on process needs.

Both new filling machines (semi-automated and fully automated) and modifications to existing machines have been installed and validated for bottles, tubes and syringes. Machines have incorporated filling, bottle insert additions, cappers, label printing & application and cartoning with PIL insert and printing.

Facilities

Projects ranging from new build pharmaceutical facilities, graded areas and the modification of existing structures, fabric and flooring to accommodate new equipment and manufacturing processes. The projects have included all aspects of environmental control systems (HVAC, Dehumidification) and subsequent integration with the Building Management System (BMS).

Complete site BMS upgrades have been completed to ensure the system is up to date with current technology to enable full & economical control of the environmental conditions throughout the manufacturing facilities.

Installation of new CCTV systems to Home Office approved facilities has been carried out under our complete management. This has been inclusive of all manufacturing and packaging areas including controlled drugs safes, office space, external grounds and car parking areas.

Utilities

IPS have previously developed and executed services relating’s to the design, installation, commissioning and full validation for all manors of utility supply’s including: Purified water, WFI (Water for Injection), Plant Steam and clean Steam and Compressed Air.

Purified Water systems

IPS is in the process of de-commissioning & removal of an existing purified water generation & distribution plant. The new generation system has been designed to provide purified water at a rate of 3m³/hr. at a conductivity of less than 1µs. The system will have in-line filters and UV sterilisers and a 3000L capacity holding tank.

During installation, the system will be integrated into the site BMS to monitor and alarm if necessary purity of water and low levels within the holding tank.
The project will involve collaboration with suppliers of the new plant to ensure the proposed system is fit for purpose. Following which the installation, commissioning and full validation of a new continuous electro-deionization (EDI) purified water system will be completed.

Phase two of the project will be the replacement of the existing distribution loop with additional supply points to support increased production demands for new manufacturing processes. On completion of the new distribution loop the whole system will be re-validated to confirm the quality of water supply and conform to regulatory standards.

VOC Abatement System

Installation and commissioning of a VOC (Volatile Organic Compounds) Abatement System to ensure compliance with local emission regulations of less than 5000kg/year. The system was installed to support increased production demands whilst still complying with emissions regulations for Methylene Chloride, Ethanol (incl. Meths etc.) & Isopropanol (IPA).

HVAC & Environmental Control Systems (LAF, Fume Cupboards etc.)

IPS has completed several HVAC based projects from design, installation, commissioning and full validation of new AHU systems, to improvements of existing systems to achieve the required cleanroom grades.

In all cases full validation has been successfully completed incorporating the key control parameters of environmental control – air change rates, supply/extract velocities and volumes, non-viable particle counts, viable particle counts and smoke visualisation studies.

Performance Assessment:

Solid Dose Manufacturing facility HVAC assessment & rebalancing to achieve the required pressure regimes. During the assessment engineering works were also completed to improve the efficiency of the system.

Humidification:

Installation and validation of a humidity control system integrated into the current HVAC supply to a potent compression bay required for moisture sensitive products.

Containment Systems:

Procurement, installation and validation of new fume cabinets in a QC laboratory, which required a complete generation of custom URS’s to enable client approval. Upon successful procurement, our team full managed the coordination of services, including the safe transfer of existing QC production to temporary locations to allow the scheme to progress.

Small Dose Manufacture

Various projects have been completed involving the full range of manufacturing processes involved in the manufacture and processing of solid dose forms (tablets, caplets & capsules).

Works have been completed in all the following areas: dispensing, granulation (including fluid bed and tray drying), compression/capsuling, tablet coating (film & sugar) & tablet printing where IPS has provided the following services:

Tablet Compression Machines

Sourced and procured a new 400,000-tablet/min press to support increased production demands. The system included tablet Deduster, WHT control (weight, hardness, thickness) & metal detection systems. The project was managed by IPS representatives through all stages, from design through to commissioning and full validation. All the associated validation documentation was provided to the site to support regulatory requirements.

Additionally, IPS has managed and implemented numerous control system upgrades to existing compression machines with full validation package, ensuring the site remains compliant with current regulations.

Upgrades or replacement to ancillary equipment (metal detectors and WHT Control units has also been completed.

Tablet Coating & Printing Equipment

Projects including the design, procurement and subsequent installation and qualification of new equipment required for a tablet sugar and film coating process has been completed.

The coated tablets (sugar and film) then required the application of printed characters directly onto the tablet surface. The equipment was developed through a joint venture between IPS and a contract engineering company. The resolution entailed a shared printer used for both tablet types however due to the difference in tablet coating the drying systems required differing process equipment. The projects were successfully completed and all equipment/processes fully validated.

Solid Dose Packing

IPS has undertaken numerous projects within the solid dose fill/finish department, which were highlighted by an initial area/validation GAP analysis.
The main focus of the assessment was to implement a new site policy to improve and manage the approach to packing validation. A benchmark of current validation status was applied and a worst-case matrix approach to re-validation implemented. This process is now in place on site and has subsequently achieved regulatory acceptance by the MHRA during an audit.
Additionally work has been completed to upgrade existing lines with new blister vision systems and checkweighers. All systems have been installed and fully validated, including CSV aspects of the systems by IPS and are now in routine use.

Projects including the integration of printing & labelling equipment required for the application of human readable and 2D Datamatrix serialised coding & the associated OCV (Optical Character Verification) equipment/software systems.

These also included the installation of line clients and Level 3 system to allow serialised number generation and management through to Level 4 Repository systems.

Services

Turnkey Projects

Integrated Pharma Services Limited provide a “single stop” fully managed solution for clients in the regulated industries. Our people understand the specialist nature of these industries and remain focused on the stringent requirements and working conditions within our chosen specialism.

Our fully integrated team of relevant and experienced professionals offer the complete range of services required to successfully deliver projects through the conception, design, construction, fit out and validation phases, all through a single point of contact.

Supply of Key Elements to Support a Client's Project

Integrated Pharma Services Limited can undertake any combination of a number of stand-alone services to support your project. Please follow the link to our services page to find out more.

Integrate with the Client's Project Team

Integrated Pharma Services Limited can integrate seamlessly into the Client’s in-house project team to undertake specific ‘backroom’ functions to assist in the successful completion of the projects.

Contact

Integrated Life Science Group
Independence House, Holly Bank Road,
Huddersfield HD3 3LX

+44 (0)1484 613 714  |  info@ilsgroup.co.uk  |  LinkedIn

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