Cleanroom / Healthcare
EPC SOLUTION
EPC Solution from Design to construction with validation ( V&Q) to develop to manufacturing facility at par of global standard by providing end to end solution under on single roof.
“Mazzetti” as an Engineering partner has fetched enrich cleanroom expertise of more than 700+ Clients & 6000+ Cleanroom projects worldwide.
We are committed to providing high & state of art Technical, Construction & Management Solutions for various cleanroom sectors as per ISO 14644-1 / BS 5295 / EU GMP / WHO GMP / US FDA / UK-MHRA / +.. and have huge experience to for following cleanrooms projects.
*Dedicated team for GMP Validation & Qualification*
VALIDATION
“ In the pharmaceutical industry most if not all processes need to be validated in one way or another with the protection of the patient in the forefront of the companies mind. Slip ups in validation can damage, if not destroy a company’s reputation overnight, let alone breach compliance regulations”.
Trouble is Validation is not a quick fix, as processes and companies evolve so does the need to re-validate. In fact it’s an ever changing environment that requires constant attention in order to prove an ongoing state of compliance. In this regard validation can be described as an ever moving target and it’s easy to see why.
4 Steps to Ensuring Validation Evolves with Production & Process Changes
Reference > Potential Problem > Consequence > Cause > Preventative Action > Contingency Plan
Flow charts, check sheets and process mapping can also strengthen your data integrity position.
Validation is and always will be a continuous process, but by utilising experts, team work and preparation it doesn’t have to be a headache. At SLP we deliver vigorous testing, validation and quality assurance solutions ensuring functional intent and approved design come together in a live environment.
We offer our services with highly experience & dedicated team for following
Air Balancing.
Installed HEPA Filter Leakage (Integrity), Testing - DOP / PAO test.
Airbone Particle Measurement (Non Viable Particle Count) Test.
Recovery test.
Air Flow Direction / Pattern test (Smoke Study).
Light Intensity Testing.
Sound Level Testing.
Contamination Leak Test
BOD Incubator.
Vacuum Oven.
Drying Ovens.
Cooling Chamber.
Walk in Cold Room.
Deep Freezers.
Cryogenic Freezers.
Glassware Ovens.
Packing Material Storage Area.
Capsule Storage Area.
Retain Storage Area.
In-process Material Storage Area.
Production Processing Area.