Software Solutions with Advanced Process Control

Siemens and Per­cep­tive Engi­neer­ing announce a part­ner­ship which offers Per­cep­tive’s Phar­maMV and Siemens Simat­ic Sipat soft­ware prod­ucts close­ly inte­grat­ed to pro­vide a ver­sa­tile solu­tion for advanced con­trol and opti­miza­tion appli­ca­tions in both con­tin­u­ous and batch phar­ma­ceu­ti­cal man­u­fac­tur­ing. The inter­est to have APC inte­grat­ed into a PAT plat­form is grow­ing sig­nif­i­cant­ly with­in the Life Sci­ences Indus­try. Thus, the goal of this col­lab­o­ra­tion is to offer the Phar­ma­ceu­ti­cal Indus­try the inte­grat­ed com­bi­na­tion of tech­nolo­gies that have — inde­pen­dent­ly from each oth­er — estab­lished a proven track record in the past decade.
An inte­grat­ed PAT Data Man­age­ment sys­tem like Siemens’ Sipat has been increas­ing­ly adopt­ed by the reg­u­lat­ed indus­tries, offer­ing a 21CFR11 com­pli­ant PAT plat­form to mon­i­tor the end prod­uct qual­i­ty in real-time while it’s been pro­duced. This is based on the struc­tured col­lec­tion of data from spec­tral PAT ana­lyz­ers com­bined with tra­di­tion­al process data and raw data infor­ma­tion from e.g. a LIMS application.
Advanced Process Con­trol (APC) with Per­cep­tive Engi­neer­ing’s Per­cep­tiveAPC has been estab­lished in dif­fer­ent indus­tries, real­is­ing APC often based on process data only. Its phar­ma­ceu­ti­cal ver­sion, called Phar­maMV, has been enriched with spe­cif­ic func­tion­al­i­ties to com­ply with the require­ments in a reg­u­lat­ed environment.
The inte­grat­ed approach of both soft­ware solu­tions pro­vides a com­plete plat­form, for struc­tured data col­lec­tion, real time CQA cal­cu­la­tion and mul­ti­vari­ate mod­el­ling and mon­i­tor­ing, which is then com­bined with auto­mat­ed mul­ti­vari­able feed­back direct­ly into the process con­trol lay­er to simul­ta­ne­ous­ly main­tain all CQA’s with­in the desired design space.
This com­bined plat­form has now been deployed with major Phar­ma­ceu­ti­cal part­ners, and at key inno­va­tion cen­tres around the world. Per­cep­tive Engi­neer­ing, based in the UK, Sin­ga­pore and Ire­land can pro­vide com­pli­men­ta­ry appli­ca­tion sup­port for Sipat and APC solu­tions worldwide.
Simat­ic Sipat is a scal­able and mod­u­lar soft­ware solu­tion that enables com­pa­nies to extend their PAT-based qual­i­ty con­trol strate­gies on a step-by-step basis with­in the scope of a Qual­i­ty-by-Design (QbD) based approach. With Sipat as inte­grat­ed PAT plat­form, prod­uct devel­op­ment and pro­duc­tion process­es can be mon­i­tored, con­trolled and opti­mized by mea­sur­ing and cal­cu­lat­ing the Crit­i­cal to Qual­i­ty Attrib­ut­es (CQA) of end prod­ucts in real-time. This con­tin­u­ous mon­i­tor­ing of prod­uct qual­i­ty can pre­vent devi­a­tions from spec­i­fi­ca­tions and there­fore reduce pro­duc­tion costs. In addi­tion, it allows for Real Time Release Test­ing, so final qual­i­ty inspec­tions can be reduced or com­plete­ly eliminated.
Per­cep­tive Engi­neer­ing is a lead­ing play­er in the deploy­ment of mod­el based Advanced Process Con­trol, APC, espe­cial­ly with­in the Phar­ma­ceu­ti­cal sec­tor. Phar­maMV is specif­i­cal­ly designed to sup­port devel­op­ment and deploy­ment of mul­ti­vari­able tech­nolo­gies for mon­i­tor­ing and con­trol with­in the reg­u­lat­ed Phar­ma­ceu­ti­cal pro­duc­tion envi­ron­ment. The Phar­maMV plat­form pro­vides mod­u­lar tools to design, deploy and main­tain advanced appli­ca­tions with­in a reg­u­lat­ed envi­ron­ment. The Plat­form includes soft­ware tools to ease the tran­si­tion from Devel­op­ment into Man­u­fac­tur­ing, reduc­ing the time to trans­fer knowl­edge and tech­nol­o­gy into com­mer­cial val­ue. Advanced Process Con­trol solu­tions are already avail­able for a wide range of phar­ma­ceu­ti­cal process units, for both small and large mol­e­cules, batch and con­tin­u­ous process­es, all now con­form­ing to an Indus­try 4.0 design.